Cetuximab in Combination With Paclitaxel Plus Cisplatin Versus Paclitaxel Plus Cisplatin Alone for the First-line Treatment of Metastatic Esophageal Squamous Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
This is an open-label, randomized, controlled trial. At the end of a 28-day screening period, all eligible subjects will be randomly assigned into treatment Arm A or B in a 1:1 ratio. Subjects in Arm A will receive a maximum of 6 cycles of chemotherapy (cisplatin plus paclitaxel) and cetuximab weekly in the absence of progressive disease (PD), as assessed by the Investigator, and unacceptable toxicity. After 6 cycles of treatment, subjects who derive clinical benefit will continue treatment with cetuximab as monotherapy until either PD or unacceptable toxicity. Subjects in Arm B will receive the same chemotherapy regimen as Arm A alone for a maximum of 6 cycles in the absence of PD and unacceptable toxicity.

Official Title
-----------------
A Phase II, Multicenter, Open-Label, Randomized, Controlled Study to Assess Efficacy and Safety of Cetuximab in Combination With Paclitaxel Plus Cisplatin Versus Paclitaxel Plus Cisplatin Alone for the First-line Treatment of Chinese Subjects With Metastatic Esophageal Squamous Cell Carcinoma.

Conditions
-----------------
Esophageal Cancer, Squamous Cell, Cetuximab Effect, Chemotherapy Effect

Intervention / Treatment
-----------------
* Drug: cetuximab
* Drug: cisplatin plus paclitaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written informed consent. Older than 18 years of age. Histologically proven squamous cell carcinoma of the esophagus. Metastatic ESCC, not suitable for local-regional treatment. Presence of at least 1 measurable lesion according to RECIST version 1.1. ECOG performance status of 0 or 1. Adequate bone marrow, haptic, renal, metabolic function. Exclusion Criteria: Prior chemotherapy in the metastasis setting. Prior chemotherapy within 6 months before entering this study. Previous exposure to EGFR-targeted therapy. Known central nervous system metastasis and/or leptomeningeal disease. Subjects with any concurrent medical condition or disease that will potentially compromise the conduct of the trial at the discretion of investigator.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chemotherapy (cisplatin plus paclitaxel) and cetuximab<br> | Drug: cetuximab<br>* cetuximab (EGFR monoclonal antibody) plus standard chemotherapy<br>Drug: cisplatin plus paclitaxel<br>* Chemotherapy<br>|
| Active Comparator: chemotherapy (cisplatin plus paclitaxel)<br> | Drug: cisplatin plus paclitaxel<br>* Chemotherapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | 
| overall response rate |  | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | 
| Disease control rate |  | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months | 
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |  | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |