Trial intelligence / Profile preview

Cetuximab with Chemoradiation in Gastric Cancer

NCT01611506Phase 2

Key facts

Status: Terminated
Start: Feb 2012
Primary completion: Dec 2012
Countries: 1
Modality: Engineered Antibody Formats, Antibody Conjugates, Monoclonal Antibodies

Drugs: cetuximab
Conditions: gastric cancer (GC)gastroesophageal junction adenocarcinoma

Overview

Phase 2, open-label, single-arm trial of cetuximab in gastric cancer (GC) and gastroesophageal junction adenocarcinoma. Primary endpoint: Dose Limiting Toxicity. Started Feb 2012; status: terminated.

Design

1 arm

Study design: Non-randomizedOpen-label

Cetuximab, capecitabine, cisplatin based chemoradiation
Induction chemotherapy followed by chemoradiation, surgery, and postoperative chemotherapy.

Who it enrols

Patients with histologically proven, localized or locally advanced gastric or Siewert Type II/III GE-junction adenocarcinoma, ECOG 0-1, and no HER2 overexpression.

Endpoints

Primary

Dose Limiting Toxicity4 weeks after radio-chemo-immunotherapy

Secondary

Major Histopathological Response Rateat surgery
Metabolic Response6 weeks
Secondary Resectability3-5 weeks after neoadjuvant treatment
R0 Resection Rateat surgery
Surgical Morbidity30 days after surgery
Overall Survival3 years
Time to Local and Systemic Progression5 years
Feasibility30 days postoperatively

Beyond the preview

Go deeper on NCT01611506.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT01611506.