Induction Chemotherapy Followed by Chemoradiotherapy in Esophageal Cancer

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ClinicalTrials.gov Identifier: NCT02403531

Recruitment Status : Completed

First Posted : March 31, 2015

Last Update Posted : June 2, 2020

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Sponsor:

Information provided by (Responsible Party):

Mian XI, Sun Yat-sen University

Study Description

Brief Summary:

The contribution of induction chemotherapy before definitive chemoradiotherapy is unknown. The purpose of this study was to compare the efficacy and toxicity of induction chemotherapy followed by definitive chemoradiotherapy versus no induction chemotherapy in patients with inoperable thoracic esophageal squamous cell carcinoma.

Condition or disease	Intervention/treatment	Phase
Neoplasms	Drug: Docetaxel Drug: Cisplatin Radiation: Radiotherapy	Phase 2

Detailed Description:

108 patients were randomized to receive no induction chemotherapy (IC, Arm A) or IC (Arm B) before definitive chemoradiotherapy in patients with inoperable thoracic esophageal squamous cell carcinoma. Patients assigned to Arm B first received two cycles of 3-weekly schedule of IC, consisting of docetaxel 75 mg/m2 on day 1 and cisplatin 75 mg/m2 on day 1. The prescribed dose of radiotherapy is generally 50-60 Gy/25-28fr. The concomitant chemotherapy is docetaxel 20 mg/m2 on day 1, cisplatin 25 mg/m2 on day 1, repeated weekly during radiation.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	110 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase II Randomized Trial of Induction Chemotherapy Versus no Induction Chemotherapy Followed by Definitive Chemoradiotherapy in Patients With Inoperable Thoracic Esophageal Cancer
Actual Study Start Date :	May 1, 2015
Actual Primary Completion Date :	September 6, 2017
Actual Study Completion Date :	May 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel

Genetic and Rare Diseases Information Center resources: Esophageal Cancer

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Concurrent chemoradiotherapy Patients assigned to this Arm received concurrent chemoradiotherapy. The prescribed dose of radiotherapy is generally 50-60 Gy/25-28fr. The concomitant chemotherapy is docetaxel 20 mg/m2 on day 1, cisplatin 25 mg/m2 on day 1, repeated weekly during radiation.	Drug: Docetaxel Include brand names, serial numbers and code names to improve search results on the ClinicalTrials.gov web site. Other Name: taxotere Drug: Cisplatin Include brand names, serial numbers and code names to improve search results on the ClinicalTrials.gov web site. Other Name: DDP Radiation: Radiotherapy definitive radiotherapy Other Name: radiation
Experimental: Induction chemotherapy plus chemoradiotherapy Patients assigned to this Arm first received two cycles of 3-weekly schedule of IC before definitive chemoradiotherapy, consisting of docetaxel 75 mg/m2 on day 1 and cisplatin 75 mg/m2 on day 1. The prescribed dose of radiotherapy is generally 50-60 Gy/25-28fr. The concomitant chemotherapy is docetaxel 20 mg/m2 on day 1, cisplatin 25 mg/m2 on day 1, repeated weekly during radiation.	Drug: Docetaxel Include brand names, serial numbers and code names to improve search results on the ClinicalTrials.gov web site. Other Name: taxotere Drug: Cisplatin Include brand names, serial numbers and code names to improve search results on the ClinicalTrials.gov web site. Other Name: DDP Radiation: Radiotherapy definitive radiotherapy Other Name: radiation

Arm

Intervention/treatment

Active Comparator: Concurrent chemoradiotherapy

Patients assigned to this Arm received concurrent chemoradiotherapy. The prescribed dose of radiotherapy is generally 50-60 Gy/25-28fr. The concomitant chemotherapy is docetaxel 20 mg/m2 on day 1, cisplatin 25 mg/m2 on day 1, repeated weekly during radiation.

Drug: Docetaxel

Include brand names, serial numbers and code names to improve search results on the ClinicalTrials.gov web site.

Other Name: taxotere

Drug: Cisplatin

Include brand names, serial numbers and code names to improve search results on the ClinicalTrials.gov web site.

Other Name: DDP

Radiation: Radiotherapy

definitive radiotherapy

Other Name: radiation

Experimental: Induction chemotherapy plus chemoradiotherapy

Patients assigned to this Arm first received two cycles of 3-weekly schedule of IC before definitive chemoradiotherapy, consisting of docetaxel 75 mg/m2 on day 1 and cisplatin 75 mg/m2 on day 1. The prescribed dose of radiotherapy is generally 50-60 Gy/25-28fr. The concomitant chemotherapy is docetaxel 20 mg/m2 on day 1, cisplatin 25 mg/m2 on day 1, repeated weekly during radiation.

Drug: Docetaxel

Include brand names, serial numbers and code names to improve search results on the ClinicalTrials.gov web site.

Other Name: taxotere

Drug: Cisplatin

Include brand names, serial numbers and code names to improve search results on the ClinicalTrials.gov web site.

Other Name: DDP

Radiation: Radiotherapy

definitive radiotherapy

Other Name: radiation

Outcome Measures

Primary Outcome Measures :

overall response rate (clinical complete response and partial response) [ Time Frame: 3 months after chemoradiotherapy (plus or minus 7 days) ]
RECIST (Response Evaluation Criteria in Solid Tumors) criteria was used to determine the tumor response. Tumor response was evaluated 3 months after the completion of treatment based on barium esophagography, CT scans, and endoscopy with biopsies.

Secondary Outcome Measures :

Overall survival [ Time Frame: 3 years ]
Three years follow-up from the enrollment to the date of death from any cause or date of lost follow-up
Progression-free survival [ Time Frame: 3 years ]
From the date of randomization to the date of disease progression or last follow-up

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed squamous cell carcinoma of the esophagus;
Localized, nonmetastatic disease (T1-4, N0-1) confirmed by endoscopic ultrasound (EUS) and CT scan (according to UICC TNM version 6);
Absence of distant metastasis of solid organ;
Not suitable for surgery (either for medical reasons or patient's choice);
Age at diagnosis 18 to 70 years;
Eastern Cooperative Oncology Group performance status ≤ 2
No prior cancer therapy;
No history of concomitant or previous malignancy;
Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL;
Renal function: Cr ≤ 1.25×UNL;
Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL;
Documented informed consent to participate in the trial.

Exclusion Criteria:

Younger than 18 or older than 70 years of age;
ECOG performance status of 3 or above;
Other cancer history;
Previous radiotherapy history;
Subjects with distant metastases;
Pregnancy or breast feeding. Women of childbearing age must use effective contraception;
Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension);
Evidence of bleeding diathesis or serious infection.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02403531

Locations

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China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060

Sponsors and Collaborators

Mian XI

Investigators

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Study Chair:	Meng-Zhong Liu, MD	Sun Yat-sen University

More Information

Publications:

Ruhstaller T, Widmer L, Schuller JC, Roth A, Hess V, Mingrone W, von Moos R, Borner M, Pestalozzi BC, BalmerMajno S, Koberle D, Terraciano L, Schnider A, Bodis S, Popescu R; Swiss Group for Clinical Cancer Research (SAKK). Multicenter phase II trial of preoperative induction chemotherapy followed by chemoradiation with docetaxel and cisplatin for locally advanced esophageal carcinoma (SAKK 75/02). Ann Oncol. 2009 Sep;20(9):1522-1528. doi: 10.1093/annonc/mdp045. Epub 2009 May 22.

Koo 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.

Ilson DH, Minsky BD, Ku GY, Rusch V, Rizk N, Shah M, Kelsen DP, Capanu M, Tang L, Campbell J, Bains M. Phase 2 trial of induction and concurrent chemoradiotherapy with weekly irinotecan and cisplatin followed by surgery for esophageal cancer. Cancer. 2012 Jun 1;118(11):2820-7. doi: 10.1002/cncr.26591. Epub 2011 Oct 11.

Ajani JA, Xiao L, Roth JA, Hofstetter WL, Walsh G, Komaki R, Liao Z, Rice DC, Vaporciyan AA, Maru DM, Lee JH, Bhutani MS, Eid A, Yao JC, Phan AP, Halpin A, Suzuki A, Taketa T, Thall PF, Swisher SG. A phase II randomized trial of induction chemotherapy versus no induction chemotherapy followed by preoperative chemoradiation in patients with esophageal cancer. Ann Oncol. 2013 Nov;24(11):2844-9. doi: 10.1093/annonc/mdt339. Epub 2013 Aug 23.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Liu S, Luo L, Zhao L, Zhu Y, Liu H, Li Q, Cai L, Hu Y, Qiu B, Zhang L, Shen J, Yang Y, Liu M, Xi M. Induction chemotherapy followed by definitive chemoradiotherapy versus chemoradiotherapy alone in esophageal squamous cell carcinoma: a randomized phase II trial. Nat Commun. 2021 Jun 29;12(1):4014. doi: 10.1038/s41467-021-24288-1.

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Responsible Party:	Mian XI, Dr. Xi, Sun Yat-sen University
ClinicalTrials.gov Identifier:	NCT02403531
Other Study ID Numbers:	ICCRTEC
First Posted:	March 31, 2015 Key Record Dates
Last Update Posted:	June 2, 2020
Last Verified:	May 2020

Keywords provided by Mian XI, Sun Yat-sen University:


Esophageal cancer Chemoradiotherapy induction chemotherapy

Additional relevant MeSH terms:

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Esophageal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases	Gastrointestinal Diseases Docetaxel Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action

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