Esophageal NeoplasmPhase 3IMRTNCT01745107
Efficacy of Intensity Modulated Radiation Therapy After Surgery in Early Stage of Esophageal Carcinoma;
A Phase 3 study testing Prophylactic postoperative radiation therapy in people with Esophageal Neoplasm and Esophageal Cancer TNM Staging Primary Tumor (T) T2, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to determine the efficacy of preventive intensity modulated radiation therapy after surgery in stage T2-3N0M0 disease of thoracic esophageal squamous cell carcinoma(UICC 7th edition) and to identify the subgroup benefiting from the treatment. Read more about this study
- Who is it for?
- Ages 40 to 72 years
- Conditions the study is for
- Esophageal Neoplasm, Esophageal Cancer TNM Staging Primary Tumor (T) T2, Esophageal Cancer TNM Staging Primary Tumor (T) T3
- What is being tested?
- Prophylactic postoperative radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Oct 2012to Dec 2021
- Phase
- Phase 3
- 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 40 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage T2-3N0M0 disease of TESCC patients confirmed by pathology studies who received R0 operations in Cancer Institute \& Hospital，CAMS；
- KPS≥70 before radiotherapy;
- Did not receive neoadjuvant or adjuvant treatment;
- No clear recurrent or metastatic lesions before radiotherapy;
- Intensity modulated radiation therapy(IMRT) is accepted;
- Regular follow-up.
Who cannot join
- Exploratory thoracotomy or palliative surgery;
- No clear recurrent or metastatic sites;
- Recurrence or metastasis is not certain;
- death of no definite cause.
- Irregular follow-up;
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer institute & Hospital，Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021
About this study
Official title: Phase Ⅲ Study of Prophylactic Postoperative Intensity Modulated Radiation Therapy in Stage T2-3N0M0 Disease of Thoracic Esophageal Squamous Cell Carcinoma;
The purpose of this study is to determine the efficacy of preventive intensity modulated radiation therapy after surgery in stage T2-3N0M0 disease of thoracic esophageal squamous cell carcinoma(UICC 7th edition) and to identify the subgroup benefiting from the treatment.
Read the detailed description
Although preoperative chemoradiation therapy followed by surgery is the most common approach for patients with resectable esophageal cancer, the considerable number of esophageal cancer patients received operation as the first treatment modality. Accordingly, postoperative treatments have been playing an important role because of the poor survival rates of the patients who have been treated with resection alone. The existing data shows that the 5-yeal survival rate of stage T2-3N0M0(UICC 7th edition) of thoracic esophageal squamous cell carcinoma(TESCC) after surgery is about 50% ,and locoregional lymph nodes metastases is responsible for the main cause of failure while distal metastases account for relatively less ratio. Therefore, the subclinical residual tumor is affirmative even if the early disease has been undergone curable excision and local adjuvant treatment may be essential. While we have proved the value of prophylactic radiation therapy after radical esophagectomy for esophageal carcinoma with positive lymph node metastases and stage Ⅲ disease, there is still lack of clear evidence for prophylactic radiation therapy in stage T2-3N0M0 disease now. The comparison of conventional 2-dimensional radiotherapy after operation versus surgery alone does not show statistically significant difference for stage T2-3N0M0 disease in our previous report. In the precise radiotherapy setting, more and more evidences of non-randomised control study indicate the trend or preliminary results of dosimetric advantages of IMRT translating into substantive benefits in both survival and locoregional control compared with 3- dimensional conformal and 2-dimensional conventional radiotherapy for the treatment of esophageal carcinoma, but it remains to be confirmed in the randomized control study that whether the IMRT is effective to improve the clinical outcomes of stage T2-3N0M0 patients of TESCC. In view of this, we designed the randomized controlled trial to determine the clinical efficacy and toxicity of prophylactic IMRT after surgery in stage T2-3N0M0 disease of TESCC.
- Conditions
- Esophageal Neoplasm, Esophageal Cancer TNM Staging Primary Tumor (T) T2, Esophageal Cancer TNM Staging Primary Tumor (T) T3, Esophageal Cancer TNM Staging Regional Lymph Nodes (N) N0, Esophageal Cancer TNM Staging Distal Metastasis (M) M0
- Being tested
- Prophylactic postoperative radiation therapy
- Keywords
- T2-3N0M0 disease of esophageal neoplasm, postoperative radiotherapy, intensity modulated radiation therapy, survival
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic postoperative radiation therapyRadiation
Also called Preventive postoperative radiotherapy
Prescription dose of 95%planning target volume(PTV) 50.4Gy/1.8Gy/28fractions for supraclavicular region and 95%PTV 56Gy/2Gy/28fractions for mediastinum which is delivered in 2 months after surgery.
| Study group | Role | What they receive |
|---|---|---|
| surgery alone | No intervention | No prophylactic postoperative radiation therapy,that is surgery alone is developed in this arm |
| surgery plus radiation | Experimental | Prophylactic postoperative radiation therapy is developed in this arm Receives: Radiation: Prophylactic postoperative radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival time
including survival time from randomization to locoregional recurrence and to distal metastasis
Measured: up to 3 years
Secondary outcomes (1)
overall survival time
survival time from randomization to death
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionDec 2018
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Esophageal NeoplasmStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Sichuan Cancer Hospital and Research Institute, Tianjin Medical University Cancer Institute and Hospital
- Responsible party
- Principal investigator, Zefen Xiao, Chinese Academy of Medical Sciences
- Investigators
- Zefen Xiao, MD, Principal investigator, The Department of Radiation Oncology ,Cancer Institute & Hospital，Chinese Academy of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745107
- Sponsor's protocol ID
- Z121107001012004
- Other IDs
- Z121107001012004
- Acronym
- IMRT
- Status last verified
- Jan 2019
- First submitted
- 6 Dec 2012
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Xiao ZF, Yang ZY, Liang J, Miao YJ, Wang M, Yin WB, Gu XZ, Zhang DC, Zhang RG, Wang LJ. Value of radiotherapy after radical surgery for esophageal carcinoma: a report of 495 patients. Ann Thorac Surg. 2003 Feb;75(2):331-6. doi: 10.1016/s0003-4975(02)04401-6.
PubMed 12607634Lin SH, Wang L, Myles B, Thall PF, Hofstetter WL, Swisher SG, Ajani JA, Cox JD, Komaki R, Liao Z. Propensity score-based comparison of long-term outcomes with 3-dimensional conformal radiotherapy vs intensity-modulated radiotherapy for esophageal cancer. Int J Radiat Oncol Biol Phys. 2012 Dec 1;84(5):1078-85. doi: 10.1016/j.ijrobp.2012.02.015. Epub 2012 Aug 3.
PubMed 22867894Chen J, Zhu J, Pan J, Zhu K, Zheng X, Chen M, Wang J, Liao Z. Postoperative radiotherapy improved survival of poor prognostic squamous cell carcinoma esophagus. Ann Thorac Surg. 2010 Aug;90(2):435-42. doi: 10.1016/j.athoracsur.2010.04.002.
PubMed 20667325Mariette C, Balon JM, Piessen G, Fabre S, Van Seuningen I, Triboulet JP. Pattern of recurrence following complete resection of esophageal carcinoma and factors predictive of recurrent disease. Cancer. 2003 Apr 1;97(7):1616-23. doi: 10.1002/cncr.11228.
PubMed 12655517Nishimaki T, Suzuki T, Suzuki S, Kuwabara S, Hatakeyama K. Outcomes of extended radical esophagectomy for thoracic esophageal cancer. J Am Coll Surg. 1998 Mar;186(3):306-12. doi: 10.1016/s1072-7515(98)00013-1.
PubMed 9510261Reeh M, Nentwich MF, von Loga K, Schade J, Uzunoglu FG, Koenig AM, Bockhorn M, Rosch T, Izbicki JR, Bogoevski D. An attempt at validation of the Seventh edition of the classification by the International Union Against Cancer for esophageal carcinoma. Ann Thorac Surg. 2012 Mar;93(3):890-6. doi: 10.1016/j.athoracsur.2011.11.035. Epub 2012 Jan 29.
PubMed 22289905Isono K, Sato H, Nakayama K. Results of a nationwide study on the three-field lymph node dissection of esophageal cancer. Oncology. 1991;48(5):411-20. doi: 10.1159/000226971.
PubMed 1745490Akiyama H, Tsurumaru M, Udagawa H, Kajiyama Y. Radical lymph node dissection for cancer of the thoracic esophagus. Ann Surg. 1994 Sep;220(3):364-72; discussion 372-3. doi: 10.1097/00000658-199409000-00012.
PubMed 8092902Chen J, Sang M, Chen Y. [Recurrence pattern and prognosis of esophageal cancer following tumor resection]. Zhonghua Zhong Liu Za Zhi. 1998 Jul;20(4):293-5. Chinese.
PubMed 10920988Visbal AL, Allen MS, Miller DL, Deschamps C, Trastek VF, Pairolero PC. Ivor Lewis esophagogastrectomy for esophageal cancer. Ann Thorac Surg. 2001 Jun;71(6):1803-8. doi: 10.1016/s0003-4975(01)02601-7.
PubMed 11426751Teniere P, Hay JM, Fingerhut A, Fagniez PL. Postoperative radiation therapy does not increase survival after curative resection for squamous cell carcinoma of the middle and lower esophagus as shown by a multicenter controlled trial. French University Association for Surgical Research. Surg Gynecol Obstet. 1991 Aug;173(2):123-30.
PubMed 1925862Fok M, Sham JS, Choy D, Cheng SW, Wong J. Postoperative radiotherapy for carcinoma of the esophagus: a prospective, randomized controlled study. Surgery. 1993 Feb;113(2):138-47.
PubMed 8430362Zieren HU, Muller JM, Jacobi CA, Pichlmaier H, Muller RP, Staar S. Adjuvant postoperative radiation therapy after curative resection of squamous cell carcinoma of the thoracic esophagus: a prospective randomized study. World J Surg. 1995 May-Jun;19(3):444-9. doi: 10.1007/BF00299187.
PubMed 7639004Chen G, Wang Z, Liu XY, Liu FY. Recurrence pattern of squamous cell carcinoma in the middle thoracic esophagus after modified Ivor-Lewis esophagectomy. World J Surg. 2007 May;31(5):1107-14. doi: 10.1007/s00268-006-0551-1.
PubMed 17426905Xiao ZF, Yang ZY, Miao YJ, Wang LH, Yin WB, Gu XZ, Zhang DC, Sun KL, Chen GY, He J. Influence of number of metastatic lymph nodes on survival of curative resected thoracic esophageal cancer patients and value of radiotherapy: report of 549 cases. Int J Radiat Oncol Biol Phys. 2005 May 1;62(1):82-90. doi: 10.1016/j.ijrobp.2004.08.046.
PubMed 15850906
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅲ Study of Prophylactic Postoperative Intensity Modulated Radiation Therapy in Stage T2-3N0M0 Disease of Thoracic Esophageal Squamous Cell Carcinoma;
- ClinicalTrials.gov ID
- NCT01745107
- Acronym / sponsor ID
- IMRT / Z121107001012004
- Conditions
- Esophageal Neoplasm, Esophageal Cancer TNM Staging Primary Tumor (T) T2, Esophageal Cancer TNM Staging Primary Tumor (T) T3, Esophageal Cancer TNM Staging Regional Lymph Nodes (N) N0, Esophageal Cancer TNM Staging Distal Metastasis (M) M0
- Keywords
- T2-3N0M0 disease of esophageal neoplasm, postoperative radiotherapy, intensity modulated radiation therapy, survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Sichuan Cancer Hospital and Research Institute, Tianjin Medical University Cancer Institute and Hospital
- Study start
- Oct 2012 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2021 (estimated)
- First posted
- 7 Dec 2012 (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.
The purpose of this study is to determine the efficacy of preventive intensity modulated radiation therapy after surgery in stage T2-3N0M0 disease of thoracic esophageal squamous cell carcinoma(UICC 7th edition) and to identify the subgroup benefiting from the treatment.
Detailed description
Although preoperative chemoradiation therapy followed by surgery is the most common approach for patients with resectable esophageal cancer, the considerable number of esophageal cancer patients received operation as the first treatment modality. Accordingly, postoperative treatments have been playing an important role because of the poor survival rates of the patients who have been treated with resection alone. The existing data shows that the 5-yeal survival rate of stage T2-3N0M0(UICC 7th edition) of thoracic esophageal squamous cell carcinoma(TESCC) after surgery is about 50% ,and locoregional lymph nodes metastases is responsible for the main cause of failure while distal metastases account for relatively less ratio. Therefore, the subclinical residual tumor is affirmative even if the early disease has been undergone curable excision and local adjuvant treatment may be essential. While we have proved the value of prophylactic radiation therapy after radical esophagectomy for esophageal carcinoma with positive lymph node metastases and stage Ⅲ disease, there is still lack of clear evidence for prophylactic radiation therapy in stage T2-3N0M0 disease now. The comparison of conventional 2-dimensional radiotherapy after operation versus surgery alone does not show statistically significant difference for stage T2-3N0M0 disease in our previous report. In the precise radiotherapy setting, more and more evidences of non-randomised control study indicate the trend or preliminary results of dosimetric advantages of IMRT translating into substantive benefits in both survival and locoregional control compared with 3- dimensional conformal and 2-dimensional conventional radiotherapy for the treatment of esophageal carcinoma, but it remains to be confirmed in the randomized control study that whether the IMRT is effective to improve the clinical outcomes of stage T2-3N0M0 patients of TESCC. In view of this, we designed the randomized controlled trial to determine the clinical efficacy and toxicity of prophylactic IMRT after surgery in stage T2-3N0M0 disease of TESCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery alone | No intervention | –No prophylactic postoperative radiation therapy,that is surgery alone is developed in this arm |
| surgery plus radiation | Experimental | Radiation: Prophylactic postoperative radiation therapyProphylactic postoperative radiation therapy is developed in this arm |
Who may qualify
- Ages
- 40 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stage T2-3N0M0 disease of TESCC patients confirmed by pathology studies who received R0 operations in Cancer Institute \& Hospital，CAMS；
- KPS≥70 before radiotherapy;
- Did not receive neoadjuvant or adjuvant treatment;
- No clear recurrent or metastatic lesions before radiotherapy;
- Intensity modulated radiation therapy(IMRT) is accepted;
Key exclusion criteria (5 listed)
- Exploratory thoracotomy or palliative surgery;
- No clear recurrent or metastatic sites;
- Recurrence or metastasis is not certain;
- death of no definite cause.
- Irregular follow-up;
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 |
|---|---|---|
| Prophylactic postoperative radiation therapyAlso: Preventive postoperative radiotherapyPrescription dose of 95%planning target volume(PTV) 50.4Gy/1.8Gy/28fractions for supraclavicular region and 95%PTV 56Gy/2Gy/28fractions for mediastinum which is delivered in 2 months after surgery. | Radiation | surgery plus radiation |
Primary outcome
Disease-free survival time
Time frame: up to 3 years
including survival time from randomization to locoregional recurrence and to distal metastasis
1 secondary outcome
overall survival time
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Background: PubMed 12607634Xiao ZF, Yang ZY, Liang J, Miao YJ, Wang M, Yin WB, Gu XZ, Zhang DC, Zhang RG, Wang LJ. Value of radiotherapy after radical surgery for esophageal carcinoma: a report of 495 patients. Ann Thorac Surg. 2003 Feb;75(2):331-6. doi: 10.1016/s0003-4975(02)04401-6.
- Background: PubMed 22867894Lin SH, Wang L, Myles B, Thall PF, Hofstetter WL, Swisher SG, Ajani JA, Cox JD, Komaki R, Liao Z. Propensity score-based comparison of long-term outcomes with 3-dimensional conformal radiotherapy vs intensity-modulated radiotherapy for esophageal cancer. Int J Radiat Oncol Biol Phys. 2012 Dec 1;84(5):1078-85. doi: 10.1016/j.ijrobp.2012.02.015. Epub 2012 Aug 3.
- Background: PubMed 20667325Chen J, Zhu J, Pan J, Zhu K, Zheng X, Chen M, Wang J, Liao Z. Postoperative radiotherapy improved survival of poor prognostic squamous cell carcinoma esophagus. Ann Thorac Surg. 2010 Aug;90(2):435-42. doi: 10.1016/j.athoracsur.2010.04.002.
- Background: PubMed 12655517Mariette C, Balon JM, Piessen G, Fabre S, Van Seuningen I, Triboulet JP. Pattern of recurrence following complete resection of esophageal carcinoma and factors predictive of recurrent disease. Cancer. 2003 Apr 1;97(7):1616-23. doi: 10.1002/cncr.11228.
- Background: PubMed 9510261Nishimaki T, Suzuki T, Suzuki S, Kuwabara S, Hatakeyama K. Outcomes of extended radical esophagectomy for thoracic esophageal cancer. J Am Coll Surg. 1998 Mar;186(3):306-12. doi: 10.1016/s1072-7515(98)00013-1.
- Background: PubMed 22289905Reeh M, Nentwich MF, von Loga K, Schade J, Uzunoglu FG, Koenig AM, Bockhorn M, Rosch T, Izbicki JR, Bogoevski D. An attempt at validation of the Seventh edition of the classification by the International Union Against Cancer for esophageal carcinoma. Ann Thorac Surg. 2012 Mar;93(3):890-6. doi: 10.1016/j.athoracsur.2011.11.035. Epub 2012 Jan 29.
- Background: PubMed 1745490Isono K, Sato H, Nakayama K. Results of a nationwide study on the three-field lymph node dissection of esophageal cancer. Oncology. 1991;48(5):411-20. doi: 10.1159/000226971.
- Background: PubMed 8092902Akiyama H, Tsurumaru M, Udagawa H, Kajiyama Y. Radical lymph node dissection for cancer of the thoracic esophagus. Ann Surg. 1994 Sep;220(3):364-72; discussion 372-3. doi: 10.1097/00000658-199409000-00012.
- Background: PubMed 10920988Chen J, Sang M, Chen Y. [Recurrence pattern and prognosis of esophageal cancer following tumor resection]. Zhonghua Zhong Liu Za Zhi. 1998 Jul;20(4):293-5. Chinese.
- Background: PubMed 11426751Visbal AL, Allen MS, Miller DL, Deschamps C, Trastek VF, Pairolero PC. Ivor Lewis esophagogastrectomy for esophageal cancer. Ann Thorac Surg. 2001 Jun;71(6):1803-8. doi: 10.1016/s0003-4975(01)02601-7.
- Background: PubMed 1925862Teniere P, Hay JM, Fingerhut A, Fagniez PL. Postoperative radiation therapy does not increase survival after curative resection for squamous cell carcinoma of the middle and lower esophagus as shown by a multicenter controlled trial. French University Association for Surgical Research. Surg Gynecol Obstet. 1991 Aug;173(2):123-30.
- Background: PubMed 8430362Fok M, Sham JS, Choy D, Cheng SW, Wong J. Postoperative radiotherapy for carcinoma of the esophagus: a prospective, randomized controlled study. Surgery. 1993 Feb;113(2):138-47.
- It is a national center for cancer research and treatment. It is one of the clinical trial bases approved by the Food and Drug Administration of State (SFDA)Link provided by the sponsor.
Related trials for Esophageal Neoplasm
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
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.
Zefen Xiao, MD principal investigator
The Department of Radiation Oncology ,Cancer Institute & Hospital，Chinese Academy of Medical Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prophylactic postoperative radiation therapy in people with Esophageal Neoplasm and Esophageal Cancer TNM Staging Primary Tumor (T) T2, 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 6 inclusion and 5 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 31 Jan 2019. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival time (time frame: up to 3 years). 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 NCT01745107, which also lists 19 linked publications.
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 31 Jan 2019.