Stage III Esophageal Squamous Cell CarcinomaPhase 3DCOECRTNCT02604615
The Role of Different Cycles of Chemotherapy（Capecitabine-oxaliplatin） in Esophageal Chemoradiotherapy
A Phase 3 study testing Capecitabine(Aibin), Oxaliplatin(Aiheng) and Radiotherapy in people with Stage III Esophageal Squamous Cell Carcinoma and Esophageal Neoplasms, run by The First Affiliated Hospital of Henan University of Science and Technology at 1 site in China.
Trial summary
A two-arm (two cycles' versus four cycles' capecitabine combined oxaliplatin concurrent radiotherapy) randomised Phase III clinical trial was started in Oct. 2015. Definitive chemoradiotherapy is the standard regimen in Western countries for patients with esophageal cancer who can't receive surgery or reject surgery. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Stage III Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms
- What is being tested?
- Capecitabine(Aibin), Oxaliplatin(Aiheng) and Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Dec 2020
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation and signed a consent form
- Histologically proven squamous cell carcinoma of the esophagus, initial treatment (Not had surgery, radiotherapy, chemotherapy or targeted therapy)
- the tumor was in T2-4N0-2M0, locally advanced（AJCC2002）
- Have a measurable lesions.
- Male or female who has fertility is willing to take contraceptive measures in the experiment
- WBC≥3x10 9/L；Hb≥80g/L；ANC ≥1.5x10 9/L；PLT ≥100x10 9/L；TBIL< 1.5xN；AST (SGOT)/ALT (SGPT) ≤2.5xN；Cr≤1.5xN.
- Performance status score 0-2
- Expected lifetime>3 months
Who cannot join
- Pregnant, lactating women or With fertility but did not use contraceptive measures
- Has a history of severe allergic or idiosyncrasy
- Hab been treated with surgery, radiation and chemotherapy or targeted therapy for esophageal cancer
- After exploratory thoracotomy or Laying an esophageal tracheal stent
- Received a major surgery treatment within 28 days prior to the start of research and treatment
- History of organ transplantation
Show all 11Show fewer
- Has uncontrolled seizures or Lose self-knowledge because of mental illness
- Severe infection
- Oral capecitabine who have difficulty with,such as esophageal obstructed completely, dysphagia,The activities of digestive ulcer, Gastrointestinal bleeding
- Severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,high blood pressure, diabetes.
- Other malignant tumor in recent 5 years.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003
shegan gao, doctor, 0379 64811906, gsg112258@163.com
tanyou shan, master, 0379 64815350, shantanyou@163.com
About this study
Official title: Two Cycles Versus Four Cycles of Capecitabine Combined Oxaliplatin Concurrent Radiotherapy as First-line Therapy for Chinese Locally Advanced Esophageal Squamous Cell Carcinomas, an Open Randomised Phase III Cilinical Trial
A two-arm (two cycles' versus four cycles' capecitabine combined oxaliplatin concurrent radiotherapy) randomised Phase III clinical trial was started in Oct. 2015. Definitive chemoradiotherapy is the standard regimen in Western countries for patients with esophageal cancer who can't receive surgery or reject surgery. But in China because of its severer toxic reaction, most of patients had to discontinue treatment at the halfway way. Thus, the chemotherapy regimen of capecitabine combined oxaliplatin are widely used in clinical due to its characristic of low toxic reaction.
The purpose of this study is to confirm the efficacy and safety of the different cycles(two cycles and four cycles ) of Capecitabine-oxaliplatin in Chinese esophageal squamous carcinoma radical concurrent chemoradiotherapy. A total of 60 patients will be accrued from China within 2 years. The primary endpoint is overall survival and the secondary endpoints include progression-free survival, response rate, pathologic complete response rate and adverse events.
Read the detailed description
First: The investigators use excel generate a 5 digits random number table. After subjects sign the informed consent, investigators will chose one for themm. Subject who get an odd number will receive 2cycles' chemotheapy concurrent radiotherapy and even number receive 4cycles'. Investigators should record the congruent relationship of subjects with group code.
Second: The investigators are required to record subjects' base measurements. The base measurements items:1.Tumor confirmed date,TNM staging,History of esophageal cancer treatment;2.Demographic data,past medical history;3.physical examination(a detailed system check including general neurological examination);4.vital signs,Height,Weight;5.PS score,Quality of life;6.serum biochemistry(ALT,AST,AKP,TBIL,blood glucose,BUN,Ccr,electrolyte,et al.);7. Blood RT(RBC,HGB,WBC,ANC,PLT,et al.);8.Urine routines;9.Endoscopic biopsy(More than 3 pieces of biopsy specimens),chest CT,abdomen ultrasound/CT/MRI,PET-CT,et al.;10.Blood/urine pregnancy tests;11.Collect blood samples(5 ml);12.Preserve CorpseSample. note:Check the time limit-2 weeks before get into groups.
Third:Observation items during treatment include 3-8 items of the base measurements;Radiotherapy 20 times, should review of esophageal barium meal or chest CT. The investigators need to observe adverse event during treatment and eveluate the relationship of adverse event with researched therapeutic regimen according to the Common Terminology Criteria for Adverse Events,CTCAE) (V4.0, 2009-05-28) and accurately fill in Case Report Form(CRF).
Fourth: Follow-up items include 3-9 items of the base measurements;bood and tissue sample should also be preserved when subject receives 16th weeks' review.
The patient who withdrew from the study during researched treatment must accept the end evaluation research. The investigators must record the reason and the date of termination in patient' progress note and CRF.
Cases of complete report should transfer to data administrators after investigates by clinical research associate. Data administrators input and management data.
- Being tested
- Capecitabine(Aibin), Oxaliplatin(Aiheng), Radiotherapy
- Keywords
- Chemoradiotherapy, Esophageal Squamous Cancer, Capecitabine and oxaliplatin, Chinese, Randomized Controlled Trials
- Medical subject headings
- Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine(Aibin)Drug
Also called Aibin
capecitabine(Aibin):625mg/m2,bid d1-5; q1w, po,5 or 10 weeks in total
Oxaliplatin(Aiheng)Drug
Also called Aiheng
Oxaliplatin(Aiheng):65mg/m2,d1,8,22,29,I.V. or Oxaliplatin(Aiheng):65mg/m2,d1,8,22,29,43,50,64,71,I.V.
RadiotherapyRadiation
Also called Radiation Therapy
concurrent radiotherapy:50Gy in total,2 Gy/d,5d/w,Until disease progression or unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine-oxaliplatin 2 cycles | Experimental | oxaliplatin：65mg/m2,d1,8,22,29,I.V; capecitabine: 625mg/m2, bid d1-5; q1w, po,5 weeks in total; radiotherapy:50Gy,2 Gy/d,5d/w. Receives: Drug: Capecitabine(Aibin); Drug: Oxaliplatin(Aiheng); Radiation: Radiotherapy |
| Capecitabine-oxaliplatin 4 cycles | Active comparator | oxaliplatin:65mg/m2,d1,8,22, 29,43,50,64,71,I.V; capecitabine:625mg/m2,bid d1-5; q1w, po,10 weeks in total; radiotherapy:50Gy ,2 Gy/d,5d/w. Receives: Drug: Capecitabine(Aibin); Drug: Oxaliplatin(Aiheng); Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival, OS
Measured: 2 years
Secondary outcomes (6)
progression-free survival,PFS
Measured: 2 years
overall remission rate, ORR
Measured: 16 weeks
serious adverse event，SAE
Measured: 16 weeks
quality of life, Qol
Measured: 16 weeks
pathologic complete response rate
Measured: 16 weeks
disease control rate,DCR
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Stage III Esophageal Squamous Cell CarcinomaStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Henan University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, Xinyang Central Hospital, Anyang Tumor Hospital, No. 150 Central Hospital of the Chinese People Liberation Army
- Responsible party
- Sponsor
- Investigators
- Shegan Gao, Doctor, Study chair, The First Affiliated Hospital of Henan University of Science and TechnologyTanyou Shan, Master, Study director, The First Affiliated Hospital of Henan University of Science and TechnologyXiaoshan Feng, Doctor, Study director, The First Affiliated Hospital of Henan University of Science and TechnologyJiachun Sun, Doctor, Principal investigator, The First Affiliated Hospital of Henan University of Science and TechnologyXinshuai Wang, Doctor, Principal investigator, The First Affiliated Hospital of Henan University of Science and TechnologyGuoqiang Kong, Master, Principal investigator, The First Affiliated Hospital of Henan University of Science and TechnologyXiaozhi Yuan, Master, Study director, The First Affiliated Hospital of Henan University of Science and TechnologyRuinuo Jia, Master, Principal investigator, The First Affiliated Hospital of Henan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604615
- Sponsor's protocol ID
- capecitabine-oxaliplatin
- Acronym
- DCOECRT
- Status last verified
- Jul 2016
- First submitted
- 11 Nov 2015
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Park JW, Kim JH, Choi EK, Lee SW, Yoon SM, Song SY, Lee YS, Kim SB, Park SI, Ahn SD. Prognosis of esophageal cancer patients with pathologic complete response after preoperative concurrent chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):691-7. doi: 10.1016/j.ijrobp.2010.06.041. Epub 2010 Oct 1.
PubMed 20888705Fakhrian K, Ordu AD, Haller B, Theisen J, Lordick F, Bisof V, Molls M, Geinitz H. Cisplatin- vs. oxaliplatin-based radiosensitizing chemotherapy for squamous cell carcinoma of the esophagus: a comparison of two preoperative radiochemotherapy regimens. Strahlenther Onkol. 2014 Oct;190(11):987-92. doi: 10.1007/s00066-014-0661-x. Epub 2014 Apr 16.
PubMed 24737541Pera M, Gallego R, Montagut C, Martin-Richard M, Iglesias M, Conill C, Reig A, Balague C, Petriz L, Momblan D, Bellmunt J, Maurel J. Phase II trial of preoperative chemoradiotherapy with oxaliplatin, cisplatin, and 5-FU in locally advanced esophageal and gastric cancer. Ann Oncol. 2012 Mar;23(3):664-670. doi: 10.1093/annonc/mdr291. Epub 2011 Jun 7.
PubMed 21652581Qin TJ, An GL, Zhao XH, Tian F, Li XH, Lian JW, Pan BR, Gu SZ. Combined treatment of oxaliplatin and capecitabine in patients with metastatic esophageal squamous cell cancer. World J Gastroenterol. 2009 Feb 21;15(7):871-6. doi: 10.3748/wjg.15.871.
PubMed 19230050Chiarion-Sileni V, Innocente R, Cavina R, Ruol A, Corti L, Pigozzo J, Del Bianco P, Fumagalli U, Santoro A, Ancona E. Multi-center phase II trial of chemo-radiotherapy with 5-fluorouracil, leucovorin and oxaliplatin in locally advanced esophageal cancer. Cancer Chemother Pharmacol. 2009 May;63(6):1111-9. doi: 10.1007/s00280-008-0834-3. Epub 2008 Sep 30.
PubMed 18825381O'Connor BM, Chadha MK, Pande A, Lombardo JC, Nwogu CE, Nava HR, Yang G, Javle MM. Concurrent oxaliplatin, 5-fluorouracil, and radiotherapy in the treatment of locally advanced esophageal carcinoma. Cancer J. 2007 Mar-Apr;13(2):119-24. doi: 10.1097/PPO.0b013e318046ee1a.
PubMed 17476140Lee SJ, Kim S, Kim M, Lee J, Park YH, Im YH, Park SH. Capecitabine in combination with either cisplatin or weekly paclitaxel as a first-line treatment for metastatic esophageal squamous cell carcinoma: a randomized phase II study. BMC Cancer. 2015 Oct 14;15:693. doi: 10.1186/s12885-015-1716-9.
PubMed 26468007Xing L, Liang Y, Zhang J, Wu P, Xu D, Liu F, Yu X, Jiang Z, Song X, Zang Q, Wang W. Definitive chemoradiotherapy with capecitabine and cisplatin for elder patients with locally advanced squamous cell esophageal cancer. J Cancer Res Clin Oncol. 2014 May;140(5):867-72. doi: 10.1007/s00432-014-1615-5. Epub 2014 Mar 1.
PubMed 24578238Koo DH, Park SI, Kim YH, Kim JH, Jung HY, Lee GH, Choi KD, Song HJ, Song HY, Shin JH, Cho KJ, Yoon DH, Kim SB. Phase II study of use of a single cycle of induction chemotherapy and concurrent chemoradiotherapy containing capecitabine/cisplatin followed by surgery for patients with resectable esophageal squamous cell carcinoma: long-term follow-up data. Cancer Chemother Pharmacol. 2012 Mar;69(3):655-63. doi: 10.1007/s00280-011-1750-5. Epub 2011 Oct 4.
PubMed 21968953Lee SJ, Ahn BM, Kim JG, Sohn SK, Chae YS, Moon JH, Lee EB, Kim JC, Park IK, Jeon SW. Definitive chemoradiotherapy with capecitabine and cisplatin in patients with esophageal cancer: a pilot study. J Korean Med Sci. 2009 Feb;24(1):120-5. doi: 10.3346/jkms.2009.24.1.120. Epub 2009 Feb 28.
PubMed 19270824Lee J, Im YH, Cho EY, Hong YS, Lee HR, Kim HS, Kim MJ, Kim K, Kang WK, Park K, Shim YM. A phase II study of capecitabine and cisplatin (XP) as first-line chemotherapy in patients with advanced esophageal squamous cell carcinoma. Cancer Chemother Pharmacol. 2008 Jun;62(1):77-84. doi: 10.1007/s00280-007-0577-6. Epub 2007 Aug 31.
PubMed 17762932
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Cycles Versus Four Cycles of Capecitabine Combined Oxaliplatin Concurrent Radiotherapy as First-line Therapy for Chinese Locally Advanced Esophageal Squamous Cell Carcinomas, an Open Randomised Phase III Cilinical Trial
- ClinicalTrials.gov ID
- NCT02604615
- Acronym / sponsor ID
- DCOECRT / capecitabine-oxaliplatin
- Keywords
- Chemoradiotherapy, Esophageal Squamous Cancer, Capecitabine and oxaliplatin, Chinese, Randomized Controlled Trials
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Henan University of Science and TechnologyUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, Xinyang Central Hospital, Anyang Tumor Hospital, No. 150 Central Hospital of the Chinese People Liberation Army
- Study start
- Oct 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 13 Nov 2015 (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.
A two-arm (two cycles' versus four cycles' capecitabine combined oxaliplatin concurrent radiotherapy) randomised Phase III clinical trial was started in Oct. 2015. Definitive chemoradiotherapy is the standard regimen in Western countries for patients with esophageal cancer who can't receive surgery or reject surgery. But in China because of its severer toxic reaction, most of patients had to discontinue treatment at the halfway way. Thus, the chemotherapy regimen of capecitabine combined oxaliplatin are widely used in clinical due to its characristic of low toxic reaction.
The purpose of this study is to confirm the efficacy and safety of the different cycles(two cycles and four cycles ) of Capecitabine-oxaliplatin in Chinese esophageal squamous carcinoma radical concurrent chemoradiotherapy. A total of 60 patients will be accrued from China within 2 years. The primary endpoint is overall survival and the secondary endpoints include progression-free survival, response rate, pathologic complete response rate and adverse events.
Detailed description
First: The investigators use excel generate a 5 digits random number table. After subjects sign the informed consent, investigators will chose one for themm. Subject who get an odd number will receive 2cycles' chemotheapy concurrent radiotherapy and even number receive 4cycles'. Investigators should record the congruent relationship of subjects with group code.
Second: The investigators are required to record subjects' base measurements. The base measurements items:1.Tumor confirmed date,TNM staging,History of esophageal cancer treatment;2.Demographic data,past medical history;3.physical examination(a detailed system check including general neurological examination);4.vital signs,Height,Weight;5.PS score,Quality of life;6.serum biochemistry(ALT,AST,AKP,TBIL,blood glucose,BUN,Ccr,electrolyte,et al.);7. Blood RT(RBC,HGB,WBC,ANC,PLT,et al.);8.Urine routines;9.Endoscopic biopsy(More than 3 pieces of biopsy specimens),chest CT,abdomen ultrasound/CT/MRI,PET-CT,et al.;10.Blood/urine pregnancy tests;11.Collect blood samples(5 ml);12.Preserve CorpseSample. note:Check the time limit-2 weeks before get into groups.
Third:Observation items during treatment include 3-8 items of the base measurements;Radiotherapy 20 times, should review of esophageal barium meal or chest CT. The investigators need to observe adverse event during treatment and eveluate the relationship of adverse event with researched therapeutic regimen according to the Common Terminology Criteria for Adverse Events,CTCAE) (V4.0, 2009-05-28) and accurately fill in Case Report Form(CRF).
Fourth: Follow-up items include 3-9 items of the base measurements;bood and tissue sample should also be preserved when subject receives 16th weeks' review.
The patient who withdrew from the study during researched treatment must accept the end evaluation research. The investigators must record the reason and the date of termination in patient' progress note and CRF.
Cases of complete report should transfer to data administrators after investigates by clinical research associate. Data administrators input and management data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capecitabine-oxaliplatin 2 cycles | Experimental | Drug: Capecitabine(Aibin), Drug: Oxaliplatin(Aiheng), Radiation: Radiotherapyoxaliplatin：65mg/m2,d1,8,22,29,I.V; capecitabine: 625mg/m2, bid d1-5; q1w, po,5 weeks in total; radiotherapy:50Gy,2 Gy/d,5d/w. |
| Capecitabine-oxaliplatin 4 cycles | Active comparator | Drug: Capecitabine(Aibin), Drug: Oxaliplatin(Aiheng), Radiation: Radiotherapyoxaliplatin:65mg/m2,d1,8,22, 29,43,50,64,71,I.V; capecitabine:625mg/m2,bid d1-5; q1w, po,10 weeks in total; radiotherapy:50Gy ,2 Gy/d,5d/w. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntary participation and signed a consent form
- Histologically proven squamous cell carcinoma of the esophagus, initial treatment (Not had surgery, radiotherapy, chemotherapy or targeted therapy)
- the tumor was in T2-4N0-2M0, locally advanced（AJCC2002）
- Have a measurable lesions.
- Male or female who has fertility is willing to take contraceptive measures in the experiment
Key exclusion criteria (11 listed)
- Pregnant, lactating women or With fertility but did not use contraceptive measures
- Has a history of severe allergic or idiosyncrasy
- Hab been treated with surgery, radiation and chemotherapy or targeted therapy for esophageal cancer
- After exploratory thoracotomy or Laying an esophageal tracheal stent
- Received a major surgery treatment within 28 days prior to the start of research and treatment
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 |
|---|---|---|
| Capecitabine(Aibin)Also: Aibincapecitabine(Aibin):625mg/m2,bid d1-5; q1w, po,5 or 10 weeks in total | Drug | Capecitabine-oxaliplatin 2 cycles, Capecitabine-oxaliplatin 4 cycles |
| Oxaliplatin(Aiheng)Also: AihengOxaliplatin(Aiheng):65mg/m2,d1,8,22,29,I.V. or Oxaliplatin(Aiheng):65mg/m2,d1,8,22,29,43,50,64,71,I.V. | Drug | Capecitabine-oxaliplatin 2 cycles, Capecitabine-oxaliplatin 4 cycles |
| RadiotherapyAlso: Radiation Therapyconcurrent radiotherapy:50Gy in total,2 Gy/d,5d/w,Until disease progression or unacceptable toxicity | Radiation | Capecitabine-oxaliplatin 2 cycles, Capecitabine-oxaliplatin 4 cycles |
Primary outcome
overall survival, OS
Time frame: 2 years
6 secondary outcomes
progression-free survival,PFS
Time frame: 2 years
overall remission rate, ORR
Time frame: 16 weeks
serious adverse event，SAE
Time frame: 16 weeks
quality of life, Qol
Time frame: 16 weeks
pathologic complete response rate
Time frame: 16 weeks
disease control rate,DCR
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2016.
- Background: PubMed 20888705Park JW, Kim JH, Choi EK, Lee SW, Yoon SM, Song SY, Lee YS, Kim SB, Park SI, Ahn SD. Prognosis of esophageal cancer patients with pathologic complete response after preoperative concurrent chemoradiotherapy. Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):691-7. doi: 10.1016/j.ijrobp.2010.06.041. Epub 2010 Oct 1.
- Background: PubMed 24737541Fakhrian K, Ordu AD, Haller B, Theisen J, Lordick F, Bisof V, Molls M, Geinitz H. Cisplatin- vs. oxaliplatin-based radiosensitizing chemotherapy for squamous cell carcinoma of the esophagus: a comparison of two preoperative radiochemotherapy regimens. Strahlenther Onkol. 2014 Oct;190(11):987-92. doi: 10.1007/s00066-014-0661-x. Epub 2014 Apr 16.
- Background: PubMed 21652581Pera M, Gallego R, Montagut C, Martin-Richard M, Iglesias M, Conill C, Reig A, Balague C, Petriz L, Momblan D, Bellmunt J, Maurel J. Phase II trial of preoperative chemoradiotherapy with oxaliplatin, cisplatin, and 5-FU in locally advanced esophageal and gastric cancer. Ann Oncol. 2012 Mar;23(3):664-670. doi: 10.1093/annonc/mdr291. Epub 2011 Jun 7.
- Background: PubMed 19230050Qin TJ, An GL, Zhao XH, Tian F, Li XH, Lian JW, Pan BR, Gu SZ. Combined treatment of oxaliplatin and capecitabine in patients with metastatic esophageal squamous cell cancer. World J Gastroenterol. 2009 Feb 21;15(7):871-6. doi: 10.3748/wjg.15.871.
- Background: PubMed 18825381Chiarion-Sileni V, Innocente R, Cavina R, Ruol A, Corti L, Pigozzo J, Del Bianco P, Fumagalli U, Santoro A, Ancona E. Multi-center phase II trial of chemo-radiotherapy with 5-fluorouracil, leucovorin and oxaliplatin in locally advanced esophageal cancer. Cancer Chemother Pharmacol. 2009 May;63(6):1111-9. doi: 10.1007/s00280-008-0834-3. Epub 2008 Sep 30.
- Background: PubMed 17476140O'Connor BM, Chadha MK, Pande A, Lombardo JC, Nwogu CE, Nava HR, Yang G, Javle MM. Concurrent oxaliplatin, 5-fluorouracil, and radiotherapy in the treatment of locally advanced esophageal carcinoma. Cancer J. 2007 Mar-Apr;13(2):119-24. doi: 10.1097/PPO.0b013e318046ee1a.
- Background: PubMed 26468007Lee SJ, Kim S, Kim M, Lee J, Park YH, Im YH, Park SH. Capecitabine in combination with either cisplatin or weekly paclitaxel as a first-line treatment for metastatic esophageal squamous cell carcinoma: a randomized phase II study. BMC Cancer. 2015 Oct 14;15:693. doi: 10.1186/s12885-015-1716-9.
- Background: PubMed 24578238Xing L, Liang Y, Zhang J, Wu P, Xu D, Liu F, Yu X, Jiang Z, Song X, Zang Q, Wang W. Definitive chemoradiotherapy with capecitabine and cisplatin for elder patients with locally advanced squamous cell esophageal cancer. J Cancer Res Clin Oncol. 2014 May;140(5):867-72. doi: 10.1007/s00432-014-1615-5. Epub 2014 Mar 1.
- Background: PubMed 21968953Koo DH, Park SI, Kim YH, Kim JH, Jung HY, Lee GH, Choi KD, Song HJ, Song HY, Shin JH, Cho KJ, Yoon DH, Kim SB. Phase II study of use of a single cycle of induction chemotherapy and concurrent chemoradiotherapy containing capecitabine/cisplatin followed by surgery for patients with resectable esophageal squamous cell carcinoma: long-term follow-up data. Cancer Chemother Pharmacol. 2012 Mar;69(3):655-63. doi: 10.1007/s00280-011-1750-5. Epub 2011 Oct 4.
- Background: PubMed 19270824Lee SJ, Ahn BM, Kim JG, Sohn SK, Chae YS, Moon JH, Lee EB, Kim JC, Park IK, Jeon SW. Definitive chemoradiotherapy with capecitabine and cisplatin in patients with esophageal cancer: a pilot study. J Korean Med Sci. 2009 Feb;24(1):120-5. doi: 10.3346/jkms.2009.24.1.120. Epub 2009 Feb 28.
- Background: PubMed 17762932Lee J, Im YH, Cho EY, Hong YS, Lee HR, Kim HS, Kim MJ, Kim K, Kang WK, Park K, Shim YM. A phase II study of capecitabine and cisplatin (XP) as first-line chemotherapy in patients with advanced esophageal squamous cell carcinoma. Cancer Chemother Pharmacol. 2008 Jun;62(1):77-84. doi: 10.1007/s00280-007-0577-6. Epub 2007 Aug 31.
- 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.
Shegan Gao, Doctor study chair
The First Affiliated Hospital of Henan University of Science and Technology
Tanyou Shan, Master study director
The First Affiliated Hospital of Henan University of Science and Technology
Xiaoshan Feng, Doctor study director
The First Affiliated Hospital of Henan University of Science and Technology
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 Capecitabine(Aibin), Oxaliplatin(Aiheng) and Radiotherapy in people with Stage III Esophageal Squamous Cell Carcinoma and Esophageal Neoplasms, run by The First Affiliated Hospital of Henan University of Science and Technology 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 8 inclusion and 11 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 6 Jul 2016. 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?
Contact Shegan Gao, Doctor (18638859977, gsg112258@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival, OS (time frame: 2 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 NCT02604615, which also lists 11 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 6 Jul 2016.