Back to resultsInduction Chemotherapy Followed by Chemoradiotherapy in Esophageal Cancer
Primary Purpose
Neoplasms
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Docetaxel
Cisplatin
Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasms focused on measuring Esophageal cancer, Chemoradiotherapy, induction chemotherapy
Eligibility 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.
Sites / Locations
- Sun Yat-sen University Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Concurrent chemoradiotherapy
Induction chemotherapy plus chemoradiotherapy
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Overall survival
Three years follow-up from the enrollment to the date of death from any cause or date of lost follow-up
Progression-free survival
From the date of randomization to the date of disease progression or last follow-up
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02403531
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2015 (Actual)
Primary Completion Date
September 6, 2017 (Actual)
Study Completion Date
May 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mian XI
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms
Keywords
Esophageal cancer, Chemoradiotherapy, induction chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Concurrent chemoradiotherapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Induction chemotherapy plus chemoradiotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
taxotere
Intervention Description
Include brand names, serial numbers and code names to improve search results on the ClinicalTrials.gov web site.
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Other Intervention Name(s)
DDP
Intervention Description
Include brand names, serial numbers and code names to improve search results on the ClinicalTrials.gov web site.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Other Intervention Name(s)
radiation
Intervention Description
definitive radiotherapy
Primary Outcome Measure Information:
Title
overall response rate (clinical complete response and partial response)
Description
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.
Time Frame
3 months after chemoradiotherapy (plus or minus 7 days)
Secondary Outcome Measure Information:
Title
Overall survival
Description
Three years follow-up from the enrollment to the date of death from any cause or date of lost follow-up
Time Frame
3 years
Title
Progression-free survival
Description
From the date of randomization to the date of disease progression or last follow-up
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meng-Zhong Liu, MD
Organizational Affiliation
Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
19465425
Citation
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.
Results Reference
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PubMed Identifier
21968953
Citation
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.
Results Reference
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PubMed Identifier
21990000
Citation
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.
Results Reference
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PubMed Identifier
23975663
Citation
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.
Results Reference
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PubMed Identifier
34188053
Citation
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.
Results Reference
derived
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Induction Chemotherapy Followed by Chemoradiotherapy in Esophageal Cancer
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