PRODIGE 34 - ADAGE: Randomised phase III study evaluating adjuvant chemotherapy after resection of stage III colon adenocarcinoma in patients aged 70 and older

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fondation Franc.Cancerologie Digestive

Participant type

Patients

Age range

65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

23 Dec 2014 → ongoing

Decision date (initial)

2025-01-17

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-518741-21-00

EudraCT number

2014-002517-39

ClinicalTrials.gov

NCT02355379

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

To compare the relapse-free survival (RFS) at 3 years for 2 therapeutic strategies in each group of patients aged 70 and over after a stage III upper rectal or colon cancer resection.

Conditions and MedDRA coding

colon cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. Age ≥ 70
2. Patient deemed fit by the MCM to receive chemotherapy
3. Lee’s score (Appendix 1) examined and faxed to the RMAC
4. Stage III upper rectal or colon adenocarcinoma
5. Resection R0 of the primary tumour
6. Start of the adjuvant chemotherapy possible within 12 weeks after the surgery
7. No prior chemotherapy for colon cancer
8. Initial geriatric “patient” self-questionnaire completed and faxed to the RMAC (Appendix 2)
9. Initial geriatric “team” questionnaire completed and faxed to the RMAC (Appendix 3)
10. Effective contraception for male patients throughout the treatment and at least 6 months after stopping the oxaliplatin treatment
11. Informed consent(s) signed

Exclusion criteria 8

1. Another progressive malignant tumour (cancer not stabilised since less than 2 years)
2. Rectal cancer (localised at less than 10 cm from the anal margin by endoscopy or sub-peritoneal)
3. PMNs < 2,000/mm3 for group 1 and PMNs < 1,500/mm3 for group 2, platelets < 100,000/mm3 or haemoglobin < 9 g/dL
4. Neuropathy for the patients from group 1
5. Known total or partial dihydropyrimidine dehydrogenase (DPD) deficiency
6. Patient with severe liver insufficiency
7. Any contra-indication to the medicinal products used in the study (refer to the updated versions of the SPCs of the products used, in Appendix 8)
8. Impossibility to undergo the trial's medical follow-up for geographical, social, or psychological reasons

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is relapse-free survival (RFS). It is defined as the time limit between the randomisation date and the date of the first recurrence (local or remote) or the date of death, regardless of the cause. All second cancers, colon or not, shall not be taken into account. The living patients without recurrence shall be censored at the date of their last assessment.

Secondary endpoints 6

1. The dose intensity
2. The overall tolerance to the treatments
3. The time to recurrence
4. Overall survival
5. The time to decrease in autonomy
6. The time to decrease in the quality of life

Investigational products

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

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fondation Franc.Cancerologie Digestive

Sponsor organisation

Fondation Franc.Cancerologie Digestive

Address

7 Boulevard Jeanne D Arc

City

Dijon Cedex

Postcode

21001

Country

France

Scientific contact point

Organisation

Fondation Franc.Cancerologie Digestive

Contact name

coordonator

Public contact point

Organisation

Fondation Franc.Cancerologie Digestive

Contact name

coordonator

Third parties 1

Locations

2 EU/EEA countries · 103 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 27 files

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

Application history

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