Induction Chemotherapy Followed by Chemoradiotherapy in Esophageal Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Randomized Trial of Induction Chemotherapy Versus no Induction Chemotherapy Followed by Definitive Chemoradiotherapy in Patients With Inoperable Thoracic Esophageal Cancer

Conditions
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Neoplasms

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Cisplatin
* Radiation: Radiotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Concurrent chemoradiotherapy<br>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<br>* Include brand names, serial numbers and code names to improve search results on the ClinicalTrials.gov web site.<br>* Other names: taxotere;Drug: Cisplatin<br>* Include brand names, serial numbers and code names to improve search results on the ClinicalTrials.gov web site.<br>* Other names: DDP;Radiation: Radiotherapy<br>* definitive radiotherapy<br>* Other names: radiation;|
| Experimental: Induction chemotherapy plus chemoradiotherapy<br>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<br>* Include brand names, serial numbers and code names to improve search results on the ClinicalTrials.gov web site.<br>* Other names: taxotere;Drug: Cisplatin<br>* Include brand names, serial numbers and code names to improve search results on the ClinicalTrials.gov web site.<br>* Other names: DDP;Radiation: Radiotherapy<br>* definitive radiotherapy<br>* Other names: radiation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal cancer, Chemoradiotherapy, induction chemotherapy