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History of Changes for Study: NCT02403531
Induction Chemotherapy Followed by Chemoradiotherapy in Esophageal Cancer
Latest version (submitted May 30, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 25, 2015 None (earliest Version on record)
2 May 1, 2015 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 November 16, 2015 Study Status
4 October 12, 2016 Study Status
5 October 3, 2017 Recruitment Status, Study Status, Contacts/Locations and Study Design
6 December 31, 2018 Outcome Measures, Study Status and Study Identification
7 May 30, 2020 Recruitment Status, Study Status and Study Design
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Study NCT02403531
Submitted Date:  March 25, 2015 (v1)
Open or close this module Study Identification
Unique Protocol ID: ICNOIC
Brief Title: Induction Chemotherapy Followed by Chemoradiotherapy in Esophageal Cancer
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
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2015
Overall Status: Not yet recruiting
Study Start: May 2015
Primary Completion: April 2017 [Anticipated]
Study Completion: July 2018 [Anticipated]
First Submitted: March 19, 2015
First Submitted that
Met QC Criteria:		 March 25, 2015
First Posted: March 31, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:		 March 25, 2015
Last Update Posted: March 31, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Mian XI
Responsible Party: Sponsor-Investigator
Investigator: Mian XI
Official Title: Dr. Xi
Affiliation: Sun Yat-sen University
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module 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.
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.
Open or close this module Conditions
Conditions: Neoplasms
Keywords: Esophageal cancer
Chemoradiotherapy
induction chemotherapy
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 108 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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 Names:
  • taxotere
Drug: Cisplatin
Include brand names, serial numbers and code names to improve search results on the ClinicalTrials.gov web site.
Other Names:
  • DDP
Radiation: Radiotherapy
definitive radiotherapy
Other Names:
  • 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 Names:
  • taxotere
Drug: Cisplatin
Include brand names, serial numbers and code names to improve search results on the ClinicalTrials.gov web site.
Other Names:
  • DDP
Radiation: Radiotherapy
definitive radiotherapy
Other Names:
  • radiation
Open or close this module Outcome Measures
Primary Outcome Measures:
1. overall response rate
[ Time Frame: 3 months after the treatment (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:
1. 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
2. Progression-free survival
[ Time Frame: 3 years ]

From the date of randomization to the date of disease progression or last follow-up
3. Quality of life
[ Time Frame: 3 years ]

EORTC QLQ-C30 questionnaire was used to assess the quality of life.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

  1. Younger than 18 or older than 70 years of age;
  2. ECOG performance status of 3 or above;
  3. Other cancer history;
  4. Previous radiotherapy history;
  5. Subjects with distant metastases;
  6. Pregnancy or breast feeding. Women of childbearing age must use effective contraception;
  7. Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension);
  8. Evidence of bleeding diathesis or serious infection.
Open or close this module Contacts/Locations
Central Contact Person: Mian Xi, MD
Telephone: +86-20-87343385
Email: ximian@sysucc.org.cn
Study Officials: Meng-Zhong Liu, MD
Study Chair
Sun Yat-sen University
Locations: China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Contact:Contact: Mian Xi, MD ximian@sysucc.org.cn
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: 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. PubMed 19465425
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. PubMed 21968953
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. PubMed 21990000
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. PubMed 23975663
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