A two-stage multicenter phase II trial of concurrent induction chemoimmunotherapy with epirubicine, oxaliplatin, capecitabine and panitumumab in KRAS wild-type, resectable type II gastric adenocarcinoma - Gastric 4

Phase 1

• Conditions: Gastric cancer; MedDRA version: 12.1Level: LLTClassification code 10017764Term: Gastric cancer stage II; MedDRA version: 12.1Level: LLTClassification code 10017765Term: Gastric cancer stage III; MedDRA version: 12.1Level: LLTClassification code 10017768Term: Gastric cancer stage IV without metastases

• Registration Number: EUCTR2009-011337-27-AT
• Lead Sponsor: AGMT

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-23
• Study Completion: 2012-05-30
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

•Signed informed consent
•untreated, histologically confirmed, non-metastasizing, resectable gastric or esophageal adenocarcinoma
•KRAS wild type tumor
•T2-4 NX M0 disease – see appendix 5
•ECOG performance status 0 or 1
•Patiente 18 to 65 years old
•Ability to understand and comply with requirements of study protocol and trial partici-pation
•Patients of either sex are eligible for study entry. Women of childbearing potential must have a negative pregnancy test at screening and must use effective contraception (e.g. intrauterine device (IUD), birth control pills, or barrier device) during treatment and for 6 months following the last dose of Pmab.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Pregnant or breast feeding women.
•Women of child-bearing potential and men not willing to use effective contraception during treatment and for 6 months after the end of treatment with Pmab
•Previous malignancy other than gastric cancer in the last 5 years except curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix.
•Active bacterial, viral or fungal infection (including acute or chronic-active infection with HBV or HCV).
•Arterial or venous thromboembolism within 6 months before enrollment
•Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) <=1 year before enrollment
•History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified