Efficacy of adjuvant Imatinib in patients with intermediate-risk gastrointestinal stromal tumor with a high-risk Genomic Grade Index

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Regional De Marseille

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

13 Sep 2016 → ongoing

Decision date (initial)

2024-07-26

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-515432-71-00

EudraCT number

2014-005255-87

ClinicalTrials.gov

NCT02576080

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Assess the efficacy of adjuvant Imatinib on rate of metastatic relapse at 2 years in patients with intermediate-risk gastrointestinal stromal tumor presenting a high Genomic Grade Index.

Secondary objectives 4

1. Compare the 2 therapeutic approaches in terms of metastasis-free survival at 1 year, 2 years and 3 years
2. Compare the 2 therapeutic approaches in terms of overall survival
3. Compare the 2 therapeutic approaches in terms of Clinical and biological tolerance and safety
4. Compare the 2 therapeutic approaches in terms of quality of life of patients

Conditions and MedDRA coding

gastrointestinal stromal tumor

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Man or woman 18 years old or over and Performance Status: 0-2
2. No prior radiation therapy, no prior chemotherapy, no molecular targeted or biological therapy for the past 3 years
3. Subject with a gastrointestinal stromal tumor, intermediary risk from the Armed Forces Institute of Pathology classification [Miettenen 2006]
4. Subject with Genomic Grade Index higher than 10 determined by CGH array
5. Subject with surgery for primary tumor performed from 2 weeks to 3 months before starting adjuvant Imatinib mesylate
6. Subject with no evidence of residual macroscopic disease after surgery (RO). Microscopically infiltrated margins, or supposed to be are allowed (R1)
7. Subjects with absence of distant metastases

Exclusion criteria 7

1. Subjects meeting any of the following criteria must not be enrolled
2. Minors or pregnant or breast-feeding women.
3. Subject with a contraindication to Imatinib, a known hypersensitivity to the active substance or to any of the excipients (ambivalence clause)
4. Subject treated with medicinal products that induce CYP3A4
5. Subject who have experienced spontaneous tumor rupture before surgery (risk of spread)
6. Subject whose tumor has a PDGFRA D842V mutation evidenced by sequencing from tumor block
7. Subject whose mutational status meets the wild phenotype definition as evidenced by sequencing from tumor block

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The efficacy of adjuvant Imatinib defined by the rate of metastatic relapse at 2 years based on a thoraco-abdominal and pelvic CT-scan

Secondary endpoints 4

1. 1-year, 2-year and 3-year metastasis-free survival based on a thoraco-abdominal and pelvic CT-scan. Metastasis-free survival will be defined as the time from the baseline visit (feedback of the randomization to the patient) and the earliest date of documented radiological occurrence of metastasis.
2. Overall survival
3. Clinical and biological tolerance
4. Patients’ quality of life assesssed by a generic questionnaire: the French version of the SF36 [Leplège 1998] and s specific questionnaire, the French version of the EORTC QLQ-C30. EORTC QLQ-C30

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Regional De Marseille

Sponsor organisation

Centre Hospitalier Regional De Marseille

Address

80 Rue Brochier

City

Marseille

Postcode

13005

Country

France

Scientific contact point

Organisation

Centre Hospitalier Regional De Marseille

Contact name

Coordonator investigator

Public contact point

Organisation

Centre Hospitalier Regional De Marseille

Contact name

project manager

Locations

1 EU/EEA country · 14 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications