Prodige 70 - Circulate - Circulating Tumor DNA Based Decision for Adjuvant Treatment in Colon Cancer Stage Ii

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Dijon

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

14 Aug 2024 → ongoing

Decision date (initial)

2024-08-14

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-515297-27-00

EudraCT number

2019-000935-15

ClinicalTrials.gov

NCT04120701

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

To improve Disease Free Survival (DFS) of centralized ctDNA positive patients by the administration of FOLFOX6m adjuvant treatment.

Secondary objectives 6

1. To improve Time to recurrence (TTR) in ctDNA positive patients with adjuvant therapy versus without therapy
2. To improve Overall survival (OS) in ctDNA positive patients with adjuvant therapy versus without therapy
3. To compare DFS and OS in ctDNA positive versus ctDNA negative patients, without adjuvant treatment
4. To estimate Toxicities using NCI-CTC v4 classification in ctDNA positive patients with or without adjuvant therapy (to assess treatment tolerability in this population)
5. To improve the success rate of prognostication of stage II colo-rectal cancer by testing the added value of ctDNA on classical prognostic factors for colo-rectal cancer,
6. To identify biological factors predictive of adjuvant treatment efficacy in ctDNA+ stage II colo-rectal cancer

Conditions and MedDRA coding

colon carcinoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 20

1. Signed written informed consent obtained prior to any study specific procedures
2. Age ≥ 18 years and ≤ 80 years (provided the score of the G8 geriatric questionnaire is >14 for patients 70 years or older)
3. Histologically confirmed stage II colon and high rectum adenocarcinoma excluding low and medium rectal cancers (tumor location ≥ 12 cm from the anal verge by endoscopy and/or above the peritoneal reflection at surgery are still eligible), without gross or microscopic evidence of residual disease after surgery with curative intent. Pathology report must be faxed to CRGA just after patient’s randomization.
4. At least 12 lymph nodes analyzed
5. Patient with MSI + tumors can also be included
6. All patients must have been discussed in multidisciplinary meetings with a decision of not performing adjuvant chemotherapy
7. No metastatic disease on CT-Scan and/or liver MRI done within 3 months before randomization.
8. Randomization planned up to 11 weeks maximun after curative R0 resection
9. WHO performance Status < 2
10. No prior chemotherapy for colo-rectal cancer
11. No prior abdominal or pelvic irradiation for colo-rectal cancer
12. Life expectancy of ≥ 5 years
13. Adequate haematological function: with neutrophils ≥ 1,500 /mm3, platelet count ≥ 100,000/mm3, hemoglobin ≥ 9 g/dL (5,6 mmol/l)
14. Total bilirubin ≤ 1.5 x ULN (upper limit of normal)
15. ASAT and ALAT ≤ 2.5 x ULN
16. Alkaline phosphatase ≤ 2.5 x ULN
17. Serum creatinine ≤ 120 μmol/L or creatinine clearance ≥50 ml/min according MDRD (Modification of Diet in Renal Disease)
18. Carcinoembryogenic antigen (CEA) ≤ 1.5 x ULN after surgery (during screening period)
19. Negative pregnancy test for registration (for women of childbearing age)
20. Patient affiliated to a social security system

Exclusion criteria 10

1. T4b tumors
2. Stage I tumors (T1 or T2N0)
3. Peripheral neuropathy > grade 1
4. Comorbidity influencing the 5-year patients’ survival including clinically relevant cardiovascular disease
5. Ischemic myocardial infarction in the last year and/or unstable ischemic cardiopathy
6. Participation to another interventional study for postoperative therapy
7. study for postoperative therapy - Partial
8. Legal incapacity or physical, psychological social or geographical status interfering with the patient's ability to sign the informed consent or to finish the study
9. Medical history of other concomitant or previous malignant disease, except adequately treated in situ carcinoma of the uterine cervix, basal or squamous cell carcinoma of the skin, or cancer in complete remission for ≥ 5 years,
10. Lack of effective contraception in patients (men and/or women) of childbearing age, pregnant or breastfeeding women. Men engaging in sexual activity with women of childbearing potential, and women of childbearing potential should agree to use a method of contraception during treatment of the trial and at least 6 months after discontinuation of said treatment.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. improve 3-year DFS from 25% to 42.5% by the use of adjuvant chemotherapy

Secondary endpoints 5

1. Time to Recurrence (TTR)
2. Overall Survival (OS)
3. compare DFS and OS in ctDNA positive versus ctDNA negative patients,
4. toxicities using NCI-CTC v4 classification
5. success rate of prognostication of stage II colo-rectal cancer

Investigational products

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

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Dijon

Sponsor organisation

Centre Hospitalier Universitaire De Dijon

Address

1 Boulevard Jeanne D Arc, Bp 77908 Bp 77908

City

Dijon

Postcode

21000

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Dijon

Contact name

Coordinator

Public contact point

Organisation

Centre Hospitalier Universitaire De Dijon

Contact name

Coordinator

Third parties 3

Locations

1 EU/EEA country · 131 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 8 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