Induction Chemotherapy Followed by Chemoradiotherapy in Esophageal Cancer

NCT02403531 | Completed Phase 2 DMC

• 1 other identifier: ICCRTEC
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms

Keywords

Esophageal cancer; Chemoradiotherapy; induction chemotherapy

Outcome Measures

Primary Outcomes (1)

• overall response rate (clinical complete response and partial response)

  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.

  3 months after chemoradiotherapy (plus or minus 7 days)

Secondary Outcomes (2)

• Overall survival

  3 years

• Progression-free survival

  3 years

Study Arms (2)

Concurrent chemoradiotherapy

ACTIVE COMPARATOR

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; Drug: Cisplatin; Radiation: Radiotherapy

Induction chemotherapy plus chemoradiotherapy

EXPERIMENTAL

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; Drug: Cisplatin; Radiation: Radiotherapy

Interventions

Docetaxel DRUG

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

Also known as: taxotere

Concurrent chemoradiotherapy; Induction chemotherapy plus chemoradiotherapy

Cisplatin DRUG

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

Also known as: DDP

Concurrent chemoradiotherapy; Induction chemotherapy plus chemoradiotherapy

Radiotherapy RADIATION

definitive radiotherapy

Also known as: radiation

Concurrent chemoradiotherapy; Induction chemotherapy plus chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mian XI: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (6)

• 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.

  PMID: 19465425 BACKGROUND

• 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.

  PMID: 21968953 BACKGROUND

• 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.

  PMID: 21990000 BACKGROUND

• 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.

  PMID: 23975663 BACKGROUND

• Liu S, Chen B, Zhu Y, Wang S, Cheng X, Wang R, Hu Y, Liu H, Li Q, Zhang L, Zhao L, Liu M, Xi M. Induction chemotherapy plus chemoradiotherapy in esophageal cancer: long-term results and exploratory analyses of a randomized controlled trial. Oncologist. 2025 Jul 4;30(7):oyae295. doi: 10.1093/oncolo/oyae295.

  PMID: 39584557 DERIVED

• 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.

  PMID: 34188053 DERIVED

MeSH Terms

Conditions

Neoplasms; Esophageal Neoplasms

Interventions

Docetaxel; Cisplatin; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Therapeutics; Physical Phenomena

Study Officials

• Meng-Zhong Liu, MD

  Sun Yat-sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Xi

Study Record Dates

• First Submitted: March 19, 2015
• First Posted: March 31, 2015
• Study Start: May 1, 2015
• Primary Completion: September 6, 2017
• Study Completion: May 30, 2020
• Last Updated: June 2, 2020

Record last verified: 2020-05

Locations

CN (1)