Chemoradiation Versus Esophagectomy for Locally Advanced Esophageal Cancer
NCT ID: NCT02972372
Last Updated: 2025-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
196 participants
INTERVENTIONAL
2016-11-30
2027-12-31
Brief Summary
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Detailed Description
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Aim: to compare outcomes in Chinese patients with locally advanced resectable esophageal squamous cell cancer who have received either surgery or definitive chemoradiation (CRT).
Methods: 176 ESCC patients with T1bN+M0, T2-4aN0-2M0 will be randomized to CRT group or Surgery group.In the CRT group, patients will be given intensity modulation radiation therapy (IMRT) with 50Gy/25 fractions , and current chemotherapy with 5-fluorouracil (5-FU) basic regimens. In the surgery group, patients will received standard esophagectomy. 5 years follow-up for both groups patients.
Primary endpoints: 2 year and 5 year Disease free survival, Overall survival Second endpoints: treatment-related adverse events; the quality of life
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CRT group
3-weekly cycles of cisplatin and 5-fluorouracil chemotherapy and radical radiotherapy delivered in IMRT mode (total of 50Gy given in 25 fractions) will be given over a period 5-6 weeks.
CRT
Drug: Capecitabine(Aibin) capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 weeks in total
Other Names:
Aibin Drug: Oxaliplatin(Aiheng) Oxaliplatin(Aiheng)：65mg/m2，d1，8, 22, 29,I.V.
Other Names:
Aiheng cisplatin: 75mg/m2 d1，29 or d1, 29, 57, 85. 5-Fu：750mg/m2 CIV24h d1-4，d29-32 or d1-4，d29-32, d57-60, d85-88.
Radiation: Radiotherapy concurrent radiotherapy：IMRT radiotherapy 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity
Surgery group
The patients randomized to receive either standard esophagectomy will have the operation performed in an open manner with two-field lymphadenectomy
surgery
The patients randomized to receive either standard esophagectomy will have the operation performed in an open manner with two-field lymphadenectomy
Interventions
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CRT
Drug: Capecitabine(Aibin) capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 weeks in total
Other Names:
Aibin Drug: Oxaliplatin(Aiheng) Oxaliplatin(Aiheng)：65mg/m2，d1，8, 22, 29,I.V.
Other Names:
Aiheng cisplatin: 75mg/m2 d1，29 or d1, 29, 57, 85. 5-Fu：750mg/m2 CIV24h d1-4，d29-32 or d1-4，d29-32, d57-60, d85-88.
Radiation: Radiotherapy concurrent radiotherapy：IMRT radiotherapy 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity
surgery
The patients randomized to receive either standard esophagectomy will have the operation performed in an open manner with two-field lymphadenectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* esophageal squamous cell cancer
* mid or lower esophageal cancer
* tumor is resectable disease
* clinical stage: cT1bN+Mo, or cT2-4aN0-2M0
Exclusion Criteria
* who had a serious premorbid condition or a poor physical status that compromised a thoracotomy.
18 Years
75 Years
ALL
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Anyang Tumor Hospital
OTHER
150th Hospital of PLA
OTHER_GOV
The First Affiliated Hospital of Henan University of Science and Technology
OTHER
Responsible Party
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Principal Investigators
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Shegan Gao, MD, PhD
Role: STUDY_CHAIR
The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology
Fuyou Zhou, MD, PhD
Role: STUDY_CHAIR
Anyang Tumor Hospital
Ruinuo Jia, MD
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology
Locations
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Anyang Tumor Hospital
Anyang, Henan, China
The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology
Luoyang, Henan, China
Countries
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Central Contacts
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Facility Contacts
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References
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Teoh AY, Chiu PW, Yeung WK, Liu SY, Wong SK, Ng EK. Long-term survival outcomes after definitive chemoradiation versus surgery in patients with resectable squamous carcinoma of the esophagus: results from a randomized controlled trial. Ann Oncol. 2013 Jan;24(1):165-71. doi: 10.1093/annonc/mds206. Epub 2012 Aug 10.
Teoh AY, Yan Chiu PW, Wong TC, Liu SY, Hung Wong SK, Ng EK. Functional performance and quality of life in patients with squamous esophageal carcinoma receiving surgery or chemoradiation: results from a randomized trial. Ann Surg. 2011 Jan;253(1):1-5. doi: 10.1097/SLA.0b013e3181fcd991.
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.
Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17.
Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
Blum MA, Taketa T, Sudo K, Wadhwa R, Skinner HD, Ajani JA. Chemoradiation for esophageal cancer. Thorac Surg Clin. 2013 Nov;23(4):551-8. doi: 10.1016/j.thorsurg.2013.07.006.
Conroy T, Galais MP, Raoul JL, Bouche O, Gourgou-Bourgade S, Douillard JY, Etienne PL, Boige V, Martel-Lafay I, Michel P, Llacer-Moscardo C, Francois E, Crehange G, Abdelghani MB, Juzyna B, Bedenne L, Adenis A; Federation Francophone de Cancerologie Digestive and UNICANCER-GI Group. Definitive chemoradiotherapy with FOLFOX versus fluorouracil and cisplatin in patients with oesophageal cancer (PRODIGE5/ACCORD17): final results of a randomised, phase 2/3 trial. Lancet Oncol. 2014 Mar;15(3):305-14. doi: 10.1016/S1470-2045(14)70028-2. Epub 2014 Feb 18.
Kato K, Muro K, Minashi K, Ohtsu A, Ishikura S, Boku N, Takiuchi H, Komatsu Y, Miyata Y, Fukuda H; Gastrointestinal Oncology Study Group of the Japan Clinical Oncology Group (JCOG). Phase II study of chemoradiotherapy with 5-fluorouracil and cisplatin for Stage II-III esophageal squamous cell carcinoma: JCOG trial (JCOG 9906). Int J Radiat Oncol Biol Phys. 2011 Nov 1;81(3):684-90. doi: 10.1016/j.ijrobp.2010.06.033. Epub 2010 Oct 6.
Kato K, Nakajima TE, Ito Y, Katada C, Ishiyama H, Tokunaga SY, Tanaka M, Hironaka S, Hashimoto T, Ura T, Kodaira T, Yoshimura K. Phase II study of concurrent chemoradiotherapy at the dose of 50.4 Gy with elective nodal irradiation for Stage II-III esophageal carcinoma. Jpn J Clin Oncol. 2013 Jun;43(6):608-15. doi: 10.1093/jjco/hyt048. Epub 2013 Apr 12.
Lee 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.
Xing 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.
Jia R, Yin W, Li S, Li R, Yang J, Shan T, Zhou D, Wang W, Wan L, Zhou F, Gao S. Chemoradiation versus oesophagectomy for locally advanced oesophageal cancer in Chinese patients: study protocol for a randomised controlled trial. Trials. 2019 Apr 11;20(1):206. doi: 10.1186/s13063-019-3316-5.
Other Identifiers
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CRTESC6111
Identifier Type: -
Identifier Source: org_study_id
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