The Role of Different Cycles of Chemotherapy（Capecitabine-oxaliplatin） in Esophageal Chemoradiotherapy
DCOECRT
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
1 other identifier
interventional
60
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2014
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 11, 2015
CompletedFirst Posted
Study publicly available on registry
November 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJuly 6, 2016
July 1, 2016
3.2 years
November 11, 2015
July 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival, OS
2 years
Secondary Outcomes (6)
progression-free survival,PFS
2 years
overall remission rate, ORR
16 weeks
serious adverse event，SAE
16 weeks
quality of life, Qol
16 weeks
pathologic complete response rate
16 weeks
- +1 more secondary outcomes
Study Arms (2)
Capecitabine-oxaliplatin 2 cycles
EXPERIMENTALoxaliplatin：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 COMPARATORoxaliplatin: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.
Interventions
capecitabine(Aibin):625mg/m2,bid d1-5; q1w, po,5 or 10 weeks in total
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.
concurrent radiotherapy:50Gy in total,2 Gy/d,5d/w,Until disease progression or unacceptable toxicity
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003, China
Related Publications (11)
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.
PMID: 20888705BACKGROUNDFakhrian 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.
PMID: 24737541BACKGROUNDPera 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.
PMID: 21652581BACKGROUNDQin 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.
PMID: 19230050BACKGROUNDChiarion-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.
PMID: 18825381BACKGROUNDO'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.
PMID: 17476140BACKGROUNDLee 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.
PMID: 26468007BACKGROUNDXing 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.
PMID: 24578238BACKGROUNDKoo 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.
PMID: 21968953BACKGROUNDLee 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.
PMID: 19270824BACKGROUNDLee 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.
PMID: 17762932BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Shegan Gao, Doctor
The First Affiliated Hospital of Henan University of Science and Technology
- STUDY DIRECTOR
Tanyou Shan, Master
The First Affiliated Hospital of Henan University of Science and Technology
- STUDY DIRECTOR
Xiaoshan Feng, Doctor
The First Affiliated Hospital of Henan University of Science and Technology
- PRINCIPAL INVESTIGATOR
Jiachun Sun, Doctor
The First Affiliated Hospital of Henan University of Science and Technology
- PRINCIPAL INVESTIGATOR
Xinshuai Wang, Doctor
The First Affiliated Hospital of Henan University of Science and Technology
- PRINCIPAL INVESTIGATOR
Guoqiang Kong, Master
The First Affiliated Hospital of Henan University of Science and Technology
- STUDY DIRECTOR
Xiaozhi Yuan, Master
The First Affiliated Hospital of Henan University of Science and Technology
- PRINCIPAL INVESTIGATOR
Ruinuo Jia, Master
The First Affiliated Hospital of Henan University of Science and Technology
- PRINCIPAL INVESTIGATOR
Dan Zhou, Master
The First Affiliated Hospital of Henan University of Science and Technology
- PRINCIPAL INVESTIGATOR
Jing Ren, Master
The First Affiliated Hospital of Henan University of Science and Technology
- PRINCIPAL INVESTIGATOR
Ruina Yang, Master
The First Affiliated Hospital of Henan University of Science and Technology
- PRINCIPAL INVESTIGATOR
Dan Wang, Master
The First Affiliated Hospital of Henan University of Science and Technology
- PRINCIPAL INVESTIGATOR
Yongxuan Liu, Master
The First Affiliated Hospital of Henan University of Science and Technology
- PRINCIPAL INVESTIGATOR
Yali Zhang, Master
The First Affiliated Hospital of Henan University of Science and Technology
- PRINCIPAL INVESTIGATOR
Weijiao Yin, Master
The First Affiliated Hospital of Henan University of Science and Technology
- PRINCIPAL INVESTIGATOR
Wei Wang, Master
The First Affiliated Hospital of Henan University of Science and Technology
- PRINCIPAL INVESTIGATOR
Shiyuan Song, Master
The First Affiliated Hospital of Henan University of Science and Technology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2015
First Posted
November 13, 2015
Study Start
October 1, 2014
Primary Completion
December 1, 2017
Study Completion
December 1, 2020
Last Updated
July 6, 2016
Record last verified: 2016-07