Phase III randomised trial evaluating FOLFOX with or without DOCETAXEL (TFOX) as 1st line chemotherapy for locally advanced or metastatic oesophago-gastric adenocarcinoma

Phase 2/3

Completed

• Conditions: Locally advanced or metastatic oesogastric adenocarcinoma

• Registration Number: 2024-515221-29-00
• Lead Sponsor: Fondation Franc.Cancerologie Digestive

Brief Summary

progression-free survival 12 months after the last randomization

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-07-04
• Last Update Posted: 2024-07-04

Recruitment & Eligibility

• Status: Ended
• Sex: Not specified
• Target Recruitment: 507

Inclusion Criteria

Histologically proven adenocarcinoma of the gastric or oesogastric junction (any Siewert) (on primary tumour or metastatic lesion)

HER2 negative (HER2 positive status is defined by a positive IHC test at 3+ or IHC at 2+ with positive FISH)

Metastatic or unresectable (locally advanced) disease

Disease measurable according to RECIST v1.1 criteria (at least one measurable lesion)

No major surgical procedure during the 4 weeks prior to randomisation

Patient eligible for a 1st line of chemotherapy based on 5FU, folinic acid and oxaliplatin (FOLFOX) with or without docetaxel (TFOX)

WHO: 0-1

Age ≥ 18

Exclusion Criteria

Presence of cerebral or meningeal metastases

Radiotherapy during the 4 weeks prior to randomisation

Other concomitant cancer or a history of cancer during the previous 5 years, with the exception of carcinoma in situ of the cervix or basal cell carcinoma or epidermoid cell carcinoma of the skin which is considered to be cured

Presence of > grade 2 neuropathy according to NCIC-CTC 4.0

Known DPD deficiency

Any known specific contraindication or allergy to the treatments used in the study

Chemotherapy or radio-chemotherapy in an adjuvant situation finished less than 12 months ago

Any progressive pathology not stabilised over the past 6 months: liver impairment, renal impairment, respiratory or cardiac failure

HIV+ patients

Prior chemotherapy including oxaliplatin (except for adjuvant chemotherapy)

Prior chemotherapy including docetaxel

Study & Design

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

Primary Outcome Measures

Name	Time	Method
To assess the progression free survival at 12 months after the last randomisation		To assess the progression free survival at 12 months after the last randomisation

Secondary Outcome Measures

Name	Time	Method
To assess the overall survival		To assess the overall survival

Trial Locations

Locations (1)

HÔPITAL EUROPÉEN GEORGE POMPIDOU; 🇫🇷 PARIS, France

HÔPITAL EUROPÉEN GEORGE POMPIDOU

🇫🇷PARIS, France

Aziz ZAANAN

Site contact

0156095064

aziz.zaanan@aphp.fr