Cetuximab Effect, Chemotherapy Effect, Esophageal Cancer, Squamous Cell
Conditions
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.
Interventions
DRUGcetuximab
cetuximab (EGFR monoclonal antibody) plus standard chemotherapy
DRUGcisplatin plus paclitaxel
Chemotherapy
Sponsors
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
China
Contacts
Primary ContactZhihao Lu, MD
Outcome results
None listed