Rectal CancerIMRTNCT01863420
The Effect of Bone Marrow-sparing Intensity-Modulated Radiotherapy to GI Cancer
An observational study of Rectal Cancer and Gastric Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
Concurrent chemotherapy with external beam radiotherapy is the standard treatment of bulky or locally advanced cervical cancer, gastric cancer and rectal cancer.Despite excellent therapeutic results, acute hematologic toxicity (HT) is common with this regimen. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer, Gastric Cancer, Bone Marrow Toxicity
- What is being tested?
- Bone Marrow-sparing Intensity-Modulated Radiotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- Nov 2012to Oct 2015
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: II/III rectal cancer and gastric cancer patients
Who may be able to join
- All gastric cancer patients had to fulfill the following criteria: histologically confirmed adenocarcinoma of the stomach, cancer resected without residual disease (R0 gastrectomy), at least a D1 lymph node dissection, a classification as stage II through III according to the 2009 staging criteria of the American Joint Commission on Cancer, at least 4 cycles of chemotherapy, age greater than 18 years and less than or equal to 75 years, a performance status of 1 or lower according to Eastern Cooperative Oncology Group (ECOG) criteria, adequate function of major organs (including cardiac, hepatic, and renal functions), adequate bone marrow function (hemoglobin>10g/dL; absolute neutrophil count [ANC]≥2,000/μL; platelet count≥100,000/μL; leukocyte count ≥4,000/μL), a caloric intake greater than 1,500 kcal/day by oral route, treatment beginning no later than 4 weeks after the last cycles of chemotherapy (but a delay of 1 week was allowed to permit full recovery, with restoration of adequate nutritional intake).
- All rectal cancer patients with histologically confirmed rectal adenocarcinoma that involved the distal 12 cm of the rectum without evidence of distant metastases were eligible. The patients had to have undergone a staging evaluation within 6 weeks before initiation of the study by endoscopic ultrasonography (US), with evidence of Stage T3 or T4 tumor and/or evidence of lymph node involvement defined by the presence of at least one enlarged perirectal lymph node >8 mm in size and sonographically suspicious for metastasis. No previous RT to the pelvis and no previous chemotherapy for rectal cancer were allowed. Other inclusion criteria are age greater than 18 years and less than or equal to 75 years, a performance status of 1 or lower according to Eastern Cooperative Oncology Group (ECOG) criteria, adequate function of major organs (including cardiac, hepatic, and renal functions), adequate bone marrow function (hemoglobin>10g/dL; absolute neutrophil count [ANC]≥2,000/μL; platelet count≥100,000/μL; leukocyte count ≥4,000/μL), a caloric intake greater than 1,500 kcal/day by oral route.
Who cannot join
- For gastric patients, cases with stage IA or IB (T2aN0) disease (according to the American Joint Committee on Cancer 2002 staging system), microscopically positive resection margin, and involvement of M1 lymph node or distant metastases were excluded from the study; prior abdominal irradiation;
- For rectal patients, cases were excluded from the study if they had metastatic rectal cancer, other tumour types than adenocarcinoma of the rectum; prior pelvic irradiation;
- Other key exclusion criteria were: past or concurrent history of neoplasm except curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix; current uncontrolled infection; unresolved bowel obstruction or subobstruction; uncontrolled Crohn's disease or ulcerative colitis; current history of chronic diarrhoea; other serious illness or medical conditions; contraindication towards study drugs and radiation; prior radiotherapy, chemotherapy or any targeting therapy; administration of any other experimental drug under investigation concomitantly or within 4 weeks before eligibility; and pregnant or lactating patients.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing, Beijing Municipality, 100021
Jianyang Wang, MD, +86-13810095191, pkucell@163.com
Jing Jin, MD, +86-10-87788122, jingjin1025@163.com
About this study
Official title: Phase II Clinical Trial: The Effect of Bone Marrow-sparing Intensity-Modulated Radiotherapy (BMS-IMRT) on Reduction Acute Hematologic Toxicity in Gastric and Rectal Cancer Patients Treated With Concurrent Chemotherapy and IMRT
Concurrent chemotherapy with external beam radiotherapy is the standard treatment of bulky or locally advanced cervical cancer, gastric cancer and rectal cancer.Despite excellent therapeutic results, acute hematologic toxicity (HT) is common with this regimen. Previous studies have founded acute HT was significantly associated the volume of pelvic (PBM) and lumbosacral bone marrow (LSBM) receiving 10 and 20 Gy radiation (RT). Therefore, reducing the volume of BM receiving low-dose RT might prevent HT.
More than one-half of the body's bone marrow (BM) is located in the PBM, LSBM and proximal, where is just in the low dose of RT in patients with gastric, rectal and cervical cancer. Previous study have demonstrated highly conformal IMRT treatment plans reduced the volume of PBM irradiated resulting in less HT. We have since assumed that even better BM sparing is possible when the BM is entered as a separate constraint in the planning process. However, it is well known that hematopoietically active (red) BM is poorly visualized with computed tomography (CT). Consequently, the entire contents of the medullary canals must be entered as BM. Yet, a considerable portion of the medullary canal is comprised of inactive (yellow) marrow, which is composed primarily of fat. Contouring the entire medullary canals on CT thus overestimates the volume of active BM, unnecessarily constraining the IMRT plan. An alternative approach is the incorporation of functional BM imaging into the treatment planning process. One economical and efficiency approach involves the use of T1-weighted magnetic resonance (MR) images.
Therefore, we designed this study to test whether a separate constraint of active BM identified by MR could reduce acute HT in course of concurrent chemoradiotherapy for patients with gastric and rectal cancer.
Read the detailed description
1、Simulation All patients underwent computed tomography (CT) simulation in the supine position for gastric cancer patients and The CT scan was obtained from the T4 vertebral body to L5 cm. Oral contrast and intravenous contrast were administered prior to the CT scan.
All patients underwent computed tomography (CT) simulation in the prone position for rectal cancer patients with a full bladder and using a belly board to minimize exposure of the small bowel. Oral contrast and intravenous contrast were administered prior to the CT scan. A radio-opaque marker was placed at the anal margin. The superior and inferior limits of the acquired transaxial data (set by the topogram) were the iliac crests and 5 cm inferior to the anal marker, respectively. Intravenous contrast were administered prior to the CT scan.
2.Radiotherapy and chemotherapy For gastric cancer patients after surgery and chemotherapy,the 4500 cGy of radiation was delivered in 25 fractions, five days per week, to the tumor bed, to the regional nodes, and 2 cm beyond the proximal and distal margins of resection. The tumor bed was defined by preoperative computed tomographic (CT) imaging, barium roentgenography, and in some instances, surgical clips. Perigastric, celiac, local paraaortic, splenic, hepatoduodenal or hepatic-portal, and pancreaticoduodenal lymph nodes were included in the radiation fields. In patients with tumors of the gastroesophageal junction, paracardial and paraesophageal lymph nodes were included in the radiation fields. Concurrent chemotherapy regimen is monotherapy with capecitabine 1600mg∙m2 twice a day (b.i.d.).
For rectal cancer patients before surgery, The rectum was not opacified with barium in order to avoid contour artifacts. The gross tumor volume (GTV) was generated with the CT scan, MR scan and endoscopic ultrasonography results. Only a clinical target volume (CTV) was delineated, encompassing the entire mesorectum, Pararectal nodes were also included, together with the presacral and promontory nodes (limit to L5-S1 interspace ), and the internal iliac nodes up to the venous bifurcation. External iliac nodes were not included as they have not been a site for recurrence in our experience. On the contrary, internal pudendal nodes were included in the CTV. Organs at risk were also contoured: bladder (with intravenous contrast), small bowel (with oral contrast) and femoral heads. The small bowel was contoured on all CT slices where it could be visualized, which was highly variable among patients. IMRT is given with 5000 cGy in 25 fractions (5 weeks). Concurrent chemotherapy consists of oxaliplatin (50 mg/m2 ) intravenously over 2 h on days 1, 8, 15, 22 and 29, and capecitabine (825 mg/m2 twice day) was given orally on each day of radiation.
- Active bone marrow definition All the patient was scanned in the supine position on a 1.5 T MR scanner. For gastric cancer patients, the images were obtained from the T8 to L4 for gastric cancer patients. For rectal cancer patients, the images were obtained from the L3-4 interspace to below the ischial tuberosities for rectal cancer patients.
The MR images were subsequently fused with the planning CT scan using commercially available image fusion software. The interactive mode of the fusion software was used whereby the user manually translates and rotates the MR scan to produce the best visual overlay of the two image sets. A mutual information algorithm was then used to perform a fine adjustment. The CT and MR images (resliced along the planes of the CT scan) were subsequently displayed side-by-side. BM regions on the T1-weighted images that showed a signal intensity equal to or slightly higher than that of muscle were contoured as active BM. The range of active BM was 3cm beyond the upper limit of PTV and 3cm below the lower limit of PTV.
- Being tested
- Bone Marrow-sparing Intensity-Modulated Radiotherapy
- Keywords
- gastric cancer, rectal cancer, bone marrow toxicity, IMRT, hematologic toxicity
- Medical subject headings
- Rectal Neoplasms, Stomach Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow-sparing Intensity-Modulated RadiotherapyRadiation
Use Bone Marrow-sparing Intensity-Modulated Radiotherapy to limit the dose of active bone marrow in radiation fields. The BM regions on the T1-weighted images that showed a signal intensity equal to or slightly higher than that of muscle were contoured as active BM
| Study group | Role | What they receive |
|---|---|---|
| Rectal cancer patients | For rectal cancer patients before surgery, IMRT is given with 5000 cGy in 25 fractions (5 weeks). Concurrent chemotherapy consists of oxaliplatin (50 mg/m2 ) intravenously over 2 h on days 1, 8, 15, 22 and 29, and capecitabine (825 mg/m2 twice day) was given orally on each day of radiation.The dose constraints for active bone marrow are V5<95%, V10<88%,V20<80%,V30<65%, V40<45%. Receives: Radiation: Bone Marrow-sparing Intensity-Modulated Radiotherapy | |
| Gastric cancer patients | For gastric cancer patients after surgery and chemotherapy,the 4500 cGy of radiation was delivered in 25 fractions, five days per week. Concurrent chemotherapy regimen is monotherapy with capecitabine 1600mg∙m2 twice a day (b.i.d.).The dose constraints for active bone marrow are V5<90%, V10<80%,V20<70%,V30<55%, V40<35%. Receives: Radiation: Bone Marrow-sparing Intensity-Modulated Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematologic toxicity
According to the Radiation Therapy Oncology Group acute radiation morbidity scoring criteria, primary endpoints of interest were the white blood cell count (WBC), absolute neutrophil count (ANC), hemoglobin (Hgb), and platelet count nadirs and highest grade of each toxicity occurring within 60 days of initiation of concurrent chemoradiotherapy (CRT).
For rectal patients, Grade 2-4 leukopenia, neutropenia,anemia, and thrombocytopenia are considered as endpoints.
For gastric patients, Grade 3-4 leukopenia, neutropenia,anemia, and thrombocytopenia are considered as endpoints.
Measured: Within 60 days of initiation of concurrent chemoradiotherapy
Secondary outcomes (2)
Low dose volume
the volume of active BM receiving 5,10,20,30 and 40 Gy
Measured: Within the course of concurrent chemoradiotherapy
Conformity and Homogeneity of IMRT plan
Conformity Index (CI）and Homogeneity Index (HI) were used to evaluate the conformity and homogeneity of IMRT plan.
Measured: Within course of concurrent chemoradiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startNov 2012
- Primary completionOct 2014 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Jin, M.D., Chinese Academy of Medical Sciences
- Investigators
- Jing Jin, MD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical CollegeJianyang Wang, MD, Study director, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863420
- Sponsor's protocol ID
- LC2012B22
- Acronym
- IMRT
- Status last verified
- May 2013
- First submitted
- 26 May 2013
- Last updated
- 29 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jianyang W, Yuan T, Yuan T, Xin W, Ning L, Hua R, Hui F, Yanru F, Shulian W, Yongwen S, Yueping L, Weihu W, Yexiong L, Jing J. A prospective phase II study of magnetic resonance imaging guided hematopoietical bone marrow-sparing intensity-modulated radiotherapy with concurrent chemotherapy for rectal cancer. Radiol Med. 2016 Apr;121(4):308-14. doi: 10.1007/s11547-015-0605-2. Epub 2015 Nov 27.
PubMed 26612321
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial: The Effect of Bone Marrow-sparing Intensity-Modulated Radiotherapy (BMS-IMRT) on Reduction Acute Hematologic Toxicity in Gastric and Rectal Cancer Patients Treated With Concurrent Chemotherapy and IMRT
- ClinicalTrials.gov ID
- NCT01863420
- Acronym / sponsor ID
- IMRT / LC2012B22
- Keywords
- gastric cancer, rectal cancer, bone marrow toxicity, IMRT, hematologic toxicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 29 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Concurrent chemotherapy with external beam radiotherapy is the standard treatment of bulky or locally advanced cervical cancer, gastric cancer and rectal cancer.Despite excellent therapeutic results, acute hematologic toxicity (HT) is common with this regimen. Previous studies have founded acute HT was significantly associated the volume of pelvic (PBM) and lumbosacral bone marrow (LSBM) receiving 10 and 20 Gy radiation (RT). Therefore, reducing the volume of BM receiving low-dose RT might prevent HT.
More than one-half of the body's bone marrow (BM) is located in the PBM, LSBM and proximal, where is just in the low dose of RT in patients with gastric, rectal and cervical cancer. Previous study have demonstrated highly conformal IMRT treatment plans reduced the volume of PBM irradiated resulting in less HT. We have since assumed that even better BM sparing is possible when the BM is entered as a separate constraint in the planning process. However, it is well known that hematopoietically active (red) BM is poorly visualized with computed tomography (CT). Consequently, the entire contents of the medullary canals must be entered as BM. Yet, a considerable portion of the medullary canal is comprised of inactive (yellow) marrow, which is composed primarily of fat. Contouring the entire medullary canals on CT thus overestimates the volume of active BM, unnecessarily constraining the IMRT plan. An alternative approach is the incorporation of functional BM imaging into the treatment planning process. One economical and efficiency approach involves the use of T1-weighted magnetic resonance (MR) images.
Therefore, we designed this study to test whether a separate constraint of active BM identified by MR could reduce acute HT in course of concurrent chemoradiotherapy for patients with gastric and rectal cancer.
Detailed description
1、Simulation All patients underwent computed tomography (CT) simulation in the supine position for gastric cancer patients and The CT scan was obtained from the T4 vertebral body to L5 cm. Oral contrast and intravenous contrast were administered prior to the CT scan.
All patients underwent computed tomography (CT) simulation in the prone position for rectal cancer patients with a full bladder and using a belly board to minimize exposure of the small bowel. Oral contrast and intravenous contrast were administered prior to the CT scan. A radio-opaque marker was placed at the anal margin. The superior and inferior limits of the acquired transaxial data (set by the topogram) were the iliac crests and 5 cm inferior to the anal marker, respectively. Intravenous contrast were administered prior to the CT scan.
2.Radiotherapy and chemotherapy For gastric cancer patients after surgery and chemotherapy,the 4500 cGy of radiation was delivered in 25 fractions, five days per week, to the tumor bed, to the regional nodes, and 2 cm beyond the proximal and distal margins of resection. The tumor bed was defined by preoperative computed tomographic (CT) imaging, barium roentgenography, and in some instances, surgical clips. Perigastric, celiac, local paraaortic, splenic, hepatoduodenal or hepatic-portal, and pancreaticoduodenal lymph nodes were included in the radiation fields. In patients with tumors of the gastroesophageal junction, paracardial and paraesophageal lymph nodes were included in the radiation fields. Concurrent chemotherapy regimen is monotherapy with capecitabine 1600mg∙m2 twice a day (b.i.d.).
For rectal cancer patients before surgery, The rectum was not opacified with barium in order to avoid contour artifacts. The gross tumor volume (GTV) was generated with the CT scan, MR scan and endoscopic ultrasonography results. Only a clinical target volume (CTV) was delineated, encompassing the entire mesorectum, Pararectal nodes were also included, together with the presacral and promontory nodes (limit to L5-S1 interspace ), and the internal iliac nodes up to the venous bifurcation. External iliac nodes were not included as they have not been a site for recurrence in our experience. On the contrary, internal pudendal nodes were included in the CTV. Organs at risk were also contoured: bladder (with intravenous contrast), small bowel (with oral contrast) and femoral heads. The small bowel was contoured on all CT slices where it could be visualized, which was highly variable among patients. IMRT is given with 5000 cGy in 25 fractions (5 weeks). Concurrent chemotherapy consists of oxaliplatin (50 mg/m2 ) intravenously over 2 h on days 1, 8, 15, 22 and 29, and capecitabine (825 mg/m2 twice day) was given orally on each day of radiation.
- Active bone marrow definition All the patient was scanned in the supine position on a 1.5 T MR scanner. For gastric cancer patients, the images were obtained from the T8 to L4 for gastric cancer patients. For rectal cancer patients, the images were obtained from the L3-4 interspace to below the ischial tuberosities for rectal cancer patients.
The MR images were subsequently fused with the planning CT scan using commercially available image fusion software. The interactive mode of the fusion software was used whereby the user manually translates and rotates the MR scan to produce the best visual overlay of the two image sets. A mutual information algorithm was then used to perform a fine adjustment. The CT and MR images (resliced along the planes of the CT scan) were subsequently displayed side-by-side. BM regions on the T1-weighted images that showed a signal intensity equal to or slightly higher than that of muscle were contoured as active BM. The range of active BM was 3cm beyond the upper limit of PTV and 3cm below the lower limit of PTV.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectal cancer patients | – | Radiation: Bone Marrow-sparing Intensity-Modulated RadiotherapyFor rectal cancer patients before surgery, IMRT is given with 5000 cGy in 25 fractions (5 weeks). Concurrent chemotherapy consists of oxaliplatin (50 mg/m2 ) intravenously over 2 h on days 1, 8, 15, 22 and 29, and capecitabine (825 mg/m2 twice day) was given orally on each day of radiation.The dose constraints for active bone marrow are V5<95%, V10<88%,V20<80%,V30<65%, V40<45%. |
| Gastric cancer patients | – | Radiation: Bone Marrow-sparing Intensity-Modulated RadiotherapyFor gastric cancer patients after surgery and chemotherapy,the 4500 cGy of radiation was delivered in 25 fractions, five days per week. Concurrent chemotherapy regimen is monotherapy with capecitabine 1600mg∙m2 twice a day (b.i.d.).The dose constraints for active bone marrow are V5<90%, V10<80%,V20<70%,V30<55%, V40<35%. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- II/III rectal cancer and gastric cancer patients
Key inclusion criteria (2 listed)
- All gastric cancer patients had to fulfill the following criteria: histologically confirmed adenocarcinoma of the stomach, cancer resected without residual disease (R0 gastrectomy), at least a D1 lymph node dissection, a classification as stage II through III according to the 2009 staging criteria of the American Joint Commission on Cancer, at least 4 cycles of chemotherapy, age greater than 18 years and less than or equal to 75 years, a performance status of 1 or lower according to Eastern Cooperative Oncology Group (ECOG) criteria, adequate function of major organs (including cardiac, hepatic, and renal functions), adequate bone marrow function (hemoglobin>10g/dL; absolute neutrophil count [ANC]≥2,000/μL; platelet count≥100,000/μL; leukocyte count ≥4,000/μL), a caloric intake greater than 1,500 kcal/day by oral route, treatment beginning no later than 4 weeks after the last cycles of chemotherapy (but a delay of 1 week was allowed to permit full recovery, with restoration of adequate nutritional intake).
- All rectal cancer patients with histologically confirmed rectal adenocarcinoma that involved the distal 12 cm of the rectum without evidence of distant metastases were eligible. The patients had to have undergone a staging evaluation within 6 weeks before initiation of the study by endoscopic ultrasonography (US), with evidence of Stage T3 or T4 tumor and/or evidence of lymph node involvement defined by the presence of at least one enlarged perirectal lymph node >8 mm in size and sonographically suspicious for metastasis. No previous RT to the pelvis and no previous chemotherapy for rectal cancer were allowed. Other inclusion criteria are age greater than 18 years and less than or equal to 75 years, a performance status of 1 or lower according to Eastern Cooperative Oncology Group (ECOG) criteria, adequate function of major organs (including cardiac, hepatic, and renal functions), adequate bone marrow function (hemoglobin>10g/dL; absolute neutrophil count [ANC]≥2,000/μL; platelet count≥100,000/μL; leukocyte count ≥4,000/μL), a caloric intake greater than 1,500 kcal/day by oral route.
Key exclusion criteria (3 listed)
- For gastric patients, cases with stage IA or IB (T2aN0) disease (according to the American Joint Committee on Cancer 2002 staging system), microscopically positive resection margin, and involvement of M1 lymph node or distant metastases were excluded from the study; prior abdominal irradiation;
- For rectal patients, cases were excluded from the study if they had metastatic rectal cancer, other tumour types than adenocarcinoma of the rectum; prior pelvic irradiation;
- Other key exclusion criteria were: past or concurrent history of neoplasm except curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix; current uncontrolled infection; unresolved bowel obstruction or subobstruction; uncontrolled Crohn's disease or ulcerative colitis; current history of chronic diarrhoea; other serious illness or medical conditions; contraindication towards study drugs and radiation; prior radiotherapy, chemotherapy or any targeting therapy; administration of any other experimental drug under investigation concomitantly or within 4 weeks before eligibility; and pregnant or lactating patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone Marrow-sparing Intensity-Modulated RadiotherapyUse Bone Marrow-sparing Intensity-Modulated Radiotherapy to limit the dose of active bone marrow in radiation fields. The BM regions on the T1-weighted images that showed a signal intensity equal to or slightly higher than that of muscle were contoured as active BM | Radiation | Gastric cancer patients, Rectal cancer patients |
Primary outcome
Hematologic toxicity
Time frame: Within 60 days of initiation of concurrent chemoradiotherapy
According to the Radiation Therapy Oncology Group acute radiation morbidity scoring criteria, primary endpoints of interest were the white blood cell count (WBC), absolute neutrophil count (ANC), hemoglobin (Hgb), and platelet count nadirs and highest grade of each toxicity occurring within 60 days of initiation of concurrent chemoradiotherapy (CRT). For rectal patients, Grade 2-4 leukopenia, neutropenia,anemia, and thrombocytopenia are considered as endpoints. For gastric patients, Grade 3-4 leukopenia, neutropenia,anemia, and thrombocytopenia are considered as endpoints.
2 secondary outcomes
Low dose volume
Time frame: Within the course of concurrent chemoradiotherapy
Conformity and Homogeneity of IMRT plan
Time frame: Within course of concurrent chemoradiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2013.
- Derived from this study: PubMed 26612321Jianyang W, Yuan T, Yuan T, Xin W, Ning L, Hua R, Hui F, Yanru F, Shulian W, Yongwen S, Yueping L, Weihu W, Yexiong L, Jing J. A prospective phase II study of magnetic resonance imaging guided hematopoietical bone marrow-sparing intensity-modulated radiotherapy with concurrent chemotherapy for rectal cancer. Radiol Med. 2016 Apr;121(4):308-14. doi: 10.1007/s11547-015-0605-2. Epub 2015 Nov 27.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Jin, MD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Jianyang Wang, MD study director
Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer and Gastric Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Jin, MD (+86-13601365130, jingjin1025@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematologic toxicity (time frame: Within 60 days of initiation of concurrent chemoradiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01863420, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2013.