Rectum CancerNCT03071198
Clinical Effect of Neoadjuvant Hierarchical Treatment Based on Chemotherapy
A study testing TME, Concurrent chemo-radiotherapy and neoadjuvant CT in people with Rectum Cancer, run by Harbin Medical University at 1 site in China.
Trial summary
Clinical effect of neoadjuvant hierarchical treatment based on chemotherapy for T3-4N0-2M0 middle and lower rectal cancer Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Rectum Cancer
- What is being tested?
- TME, Concurrent chemo-radiotherapy and neoadjuvant CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2017to 30 Sep 2021
- Phase
- Interventional
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pathologically confirmed to be rectal adenocarcinoma.
- Distance < 10cm from the end of the tumor to the anal verge found on colonoscopy
- Tumor in stage T3-4N0-2 (pelvic MRI evaluation)
- Patients without distant metastases (such as liver and peritoneum, lungs, aortic lymph nodes)
- Patients with Karnofsky score greater ≥ 70
- WBC > 3.5 x 109/ml , PLT > 10 x 109/ml , TBIL<22.2 umol/l , BUN <7.14mmol/l , Cr<132umol/l or Ccr > 50ml/min (Evaluated using the Cockcroft-Gault formula: Creatinine clearance (male) = {(140 - age) x LBM (kg)} / {plasma creatinine (mg/dl) x 72} ; Creatinine clearance (female) = 0.85 x {(140 - age) x LBM(kg)}/ { plasma creatinine (mg/dl) x 72})
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- Patients must sign the informed consent form
- Female subjects must be contraceptive during the trial
- Patients who did not receive any form of chemotherapy and radiotherapy
- No other important related diseases (such as other tumors, severe heart disease and central nervous system diseases, etc.)
- Age must be equal or more than 20 and must be equal or less than 70
Who cannot join
- Previously received radiation therapy, chemotherapy or anti-tumor biological therapy
- Previously received immuno-suppressive therapy
- Participation in interventional clinical trial over the past time
- Suffering from malignant colonic neoplasms simultaneously
- With peripheral neuropathy(above WHO I level)
- Affected cognitive abilities because of neurological or psychiatric abnormalities Including central nervous system metastasis
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- Medical history of severe allergies or allergic constitution
- Severe pulmonary or heart disease history
- Female patients who are in pregnancy or lactation and refuse contraception
- Previously with other malignant tumors
- Exit criteria
- Occurrence of bleeding, obstruction, perforation and other complications
- Occurrence of distant metastasis during the period of neoadjuvant therapy
- Adverse reactions, not be tolerated and do not want to continue to receive treatment
- Patients voluntarily quit
- Capecitabine-related Grade 4 Hand-Foot Syndrome
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital Affiliated to Harbin Medical University
Harbin, Heilongjiang, 150000
binbin cui
About this study
Official title: Clinical Effect of Neoadjuvant Hierarchical Treatment Based on Chemotherapy for T3-4N0-2M0 Middle and Lower Rectal Cancer
Clinical effect of neoadjuvant hierarchical treatment based on chemotherapy for T3-4N0-2M0 middle and lower rectal cancer
Read the detailed description
By setting 3-Year disease-free survival (DFS) as main objective, the treatment strategy will be optimizing as neoadjuvant chemotherapy alone and chemo-radio-chemo sequential treatment.
- Conditions
- Rectum Cancer
- Being tested
- TME, Concurrent chemo-radiotherapy, neoadjuvant CT, adjuvant CT
- Keywords
- Neoadjuvant Chemotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMEProcedure or surgery
- Find the hypogastric nerve trunk in front of sacral promontory and protect it,be careful to use electrocautery hemostasis biased toward the side of rectal when handle lateral ligament of rectum and middle rectal artery and avoid to damage the pelvic plexus.
- At least a 2-cm margin to the lower edge of the tumor is adequate for distal bowel resection. Resect 5cm length distal rectal or all of the mesorectum.Check the integrity of the mesorectum in postoperative routine examination. Double stapling method is used for all low anastomosis operations.
Concurrent chemo-radiotherapyRadiation
Also called neoadjuvant RCT
Three-dimensional conformal radiotherapy as following: CTV 44Gy/22 times＋GTV1 6Gy/3 times(2Gy/time/day，5 days a week，totally 5 weeks),if rectal tumors do not regress obviously, additional GTV2 is necessary, 5.4Gy/3 times (1.8Gy/time/day). At the same time, Capecitabine (850mg/m2, two times every day) will be taken on radiotherapy day
neoadjuvant CTDrug
Also called neoadjuvant chemotherapy
CAPEOX protocol:Oxaliplatin 130mg/m2 ivgtt 2-6h dl;(Capecitabine 1000mg/m2 2 times a day lasts for 14 days Repeat every 3 weeks
adjuvant CTDrug
Also called adjuvant chemotherapy
CAPEOX protocol:Oxaliplatin 130mg/m2 ivgtt 2-6h dl;(Capecitabine 1000mg/m2 2 times a day lasts for 14 days Repeat every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Preoperative neoadjuvant CT | Experimental | Give neoadjuvant chemotherapy for four cycle ,if achieve cCR or cPR after four cycles neoadjuvant chemotherapy , receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy Receives: Procedure: TME; Drug: neoadjuvant CT; Drug: adjuvant CT |
| Preoperative neoadjuvant CT-RCT | Experimental | Give neoadjuvant chemotherapy for four cycle ,if not achieve cCR or cPR after four cycle neoadjuvant chemotherapy ,give concurrent chemo-radiotherapy,then additional neoadjuvant chemotherapy for 2 cycles ,then receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy Receives: Procedure: TME; Radiation: Concurrent chemo-radiotherapy; Drug: neoadjuvant CT; Drug: adjuvant CT |
| Concurrent chemo-radiotherapy | Active comparator | Give concurrent chemo-radiotherapy ,then receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy Receives: Procedure: TME; Radiation: Concurrent chemo-radiotherapy; Drug: adjuvant CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival (DFS)
the treatment strategy will be optimizing as neoadjuvant chemotherapy alone and chemo-radio-chemo sequential treatment.
Measured: 3 years
Secondary outcomes (5)
Surgery related mortality and complication
Surgery related mortality and complication
Measured: 3 years
Resection rate of R0
Resection rate of R0
Measured: 3 years
Pathologic complete remission (pCR) rate
Pathologic complete remission (pCR) rate
Measured: 3 years
Tolerance after neoadjuvant treatment
Tolerance after neoadjuvant treatment
Measured: 3 years
Predictor efficacy of neoadjuvant chemotherapy for DFS
Predictor efficacy of neoadjuvant chemotherapy for DFS
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2017
- Study start1 Mar 2017
- Primary completion30 Sep 2018 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectum 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This strategy is called "neoadjuvant hierarchical treatment" based on chemotherapy for rectal cancer. All patients with T3-4N0-2M0 middle and lower rectal caner will firstly receive neoadjuvant chemotherapy consisting of four cycles of XELOX. After four cycles, the patients achieved cCR or cPR will be perform the operation. And the patients who can not achieve cCR or cPR after the four cycles, then concurrent chemoradiotherapy will be added.
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Binbin Cui, Harbin Medical University
- Investigators
- binbin cui, Principal investigator, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071198
- Sponsor's protocol ID
- 201702230001
- Status last verified
- Mar 2017
- First submitted
- 26 Feb 2017
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effect of Neoadjuvant Hierarchical Treatment Based on Chemotherapy for T3-4N0-2M0 Middle and Lower Rectal Cancer
- ClinicalTrials.gov ID
- NCT03071198
- Acronym / sponsor ID
- 201702230001
- Conditions
- Rectum Cancer
- Keywords
- Neoadjuvant Chemotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Sep 2018 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 6 Mar 2017 (actual)
- 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.
Clinical effect of neoadjuvant hierarchical treatment based on chemotherapy for T3-4N0-2M0 middle and lower rectal cancer
Detailed description
By setting 3-Year disease-free survival (DFS) as main objective, the treatment strategy will be optimizing as neoadjuvant chemotherapy alone and chemo-radio-chemo sequential treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This strategy is called "neoadjuvant hierarchical treatment" based on chemotherapy for rectal cancer. All patients with T3-4N0-2M0 middle and lower rectal caner will firstly receive neoadjuvant chemotherapy consisting of four cycles of XELOX. After four cycles, the patients achieved cCR or cPR will be perform the operation. And the patients who can not achieve cCR or cPR after the four cycles, then concurrent chemoradiotherapy will be added.
| Arm | Type | Receives |
|---|---|---|
| Preoperative neoadjuvant CT | Experimental | Procedure: TME, Drug: neoadjuvant CT, Drug: adjuvant CTGive neoadjuvant chemotherapy for four cycle ,if achieve cCR or cPR after four cycles neoadjuvant chemotherapy , receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy |
| Preoperative neoadjuvant CT-RCT | Experimental | Procedure: TME, Radiation: Concurrent chemo-radiotherapy, Drug: neoadjuvant CT, Drug: adjuvant CTGive neoadjuvant chemotherapy for four cycle ,if not achieve cCR or cPR after four cycle neoadjuvant chemotherapy ,give concurrent chemo-radiotherapy,then additional neoadjuvant chemotherapy for 2 cycles ,then receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy |
| Concurrent chemo-radiotherapy | Active comparator | Procedure: TME, Radiation: Concurrent chemo-radiotherapy, Drug: adjuvant CTGive concurrent chemo-radiotherapy ,then receive Total Mesorectal Excision(TME) ,then received the complete adjuvant therapy |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Pathologically confirmed to be rectal adenocarcinoma.
- Distance < 10cm from the end of the tumor to the anal verge found on colonoscopy
- Tumor in stage T3-4N0-2 (pelvic MRI evaluation)
- Patients without distant metastases (such as liver and peritoneum, lungs, aortic lymph nodes)
- Patients with Karnofsky score greater ≥ 70
Key exclusion criteria (16 listed)
- Previously received radiation therapy, chemotherapy or anti-tumor biological therapy
- Previously received immuno-suppressive therapy
- Participation in interventional clinical trial over the past time
- Suffering from malignant colonic neoplasms simultaneously
- With peripheral neuropathy(above WHO I level)
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 |
|---|---|---|
| TME1. Find the hypogastric nerve trunk in front of sacral promontory and protect it,be careful to use electrocautery hemostasis biased toward the side of rectal when handle lateral ligament of rectum and middle rectal artery and avoid to damage the pelvic plexus. 2. At least a 2-cm margin to the lower edge of the tumor is adequate for distal bowel resection. Resect 5cm length distal rectal or all of the mesorectum.Check the integrity of the mesorectum in postoperative routine examination. Double stapling method is used for all low anastomosis operations. | Procedure or surgery | Concurrent chemo-radiotherapy, Preoperative neoadjuvant CT, Preoperative neoadjuvant CT-RCT |
| Concurrent chemo-radiotherapyAlso: neoadjuvant RCTThree-dimensional conformal radiotherapy as following: CTV 44Gy/22 times＋GTV1 6Gy/3 times(2Gy/time/day，5 days a week，totally 5 weeks),if rectal tumors do not regress obviously, additional GTV2 is necessary, 5.4Gy/3 times (1.8Gy/time/day). At the same time, Capecitabine (850mg/m2, two times every day) will be taken on radiotherapy day | Radiation | Concurrent chemo-radiotherapy, Preoperative neoadjuvant CT-RCT |
| neoadjuvant CTAlso: neoadjuvant chemotherapyCAPEOX protocol:Oxaliplatin 130mg/m2 ivgtt 2-6h dl;(Capecitabine 1000mg/m2 2 times a day lasts for 14 days Repeat every 3 weeks | Drug | Preoperative neoadjuvant CT, Preoperative neoadjuvant CT-RCT |
| adjuvant CTAlso: adjuvant chemotherapyCAPEOX protocol:Oxaliplatin 130mg/m2 ivgtt 2-6h dl;(Capecitabine 1000mg/m2 2 times a day lasts for 14 days Repeat every 3 weeks | Drug | Concurrent chemo-radiotherapy, Preoperative neoadjuvant CT, Preoperative neoadjuvant CT-RCT |
Primary outcome
Disease Free Survival (DFS)
Time frame: 3 years
the treatment strategy will be optimizing as neoadjuvant chemotherapy alone and chemo-radio-chemo sequential treatment.
5 secondary outcomes
Surgery related mortality and complication
Time frame: 3 years
Resection rate of R0
Time frame: 3 years
Pathologic complete remission (pCR) rate
Time frame: 3 years
Tolerance after neoadjuvant treatment
Time frame: 3 years
Predictor efficacy of neoadjuvant chemotherapy for DFS
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
- Individual participant dataSharing planned: Undecided
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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.
binbin cui principal investigator
Harbin Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TME, Concurrent chemo-radiotherapy and neoadjuvant CT in people with Rectum Cancer, run by Harbin Medical University 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 11 inclusion and 16 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 7 Mar 2017. 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 binbin Cui, Doctor (+86-13351112888, Cuibb2017@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Free Survival (DFS) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2017.