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

NCT ID: NCT03126708

Last Updated: 2018-01-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-10
• Study Completion Date: 2020-04-30

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.

Conditions

Esophageal Cancer, Squamous Cell; Cetuximab Effect; Chemotherapy Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

chemotherapy (cisplatin plus paclitaxel) and cetuximab

Group Type: EXPERIMENTAL

cetuximab

Intervention Type: DRUG

cetuximab (EGFR monoclonal antibody) plus standard chemotherapy

cisplatin plus paclitaxel

Intervention Type: DRUG

Chemotherapy

chemotherapy (cisplatin plus paclitaxel)

Group Type: ACTIVE_COMPARATOR

cisplatin plus paclitaxel

Intervention Type: DRUG

Chemotherapy

Interventions

cetuximab

cetuximab (EGFR monoclonal antibody) plus standard chemotherapy

Intervention Type: DRUG

cisplatin plus paclitaxel

Chemotherapy

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Shen Lin

Director,Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lin Shen, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Universtiy Cancer Hospital

Locations

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhihao Lu, MD

Role: CONTACT

pppeirain@126.com

86-10-88196561

Facility Contacts

Lin Shen, MD

Role: primary

lin100@medmail.com.cn

+86-10-88196561

Other Identifiers

ESCC-Cetuximab-PKU

Identifier Type: -

Identifier Source: org_study_id