CIRCULATING TUMOR DNA BASED DECISION FOR ADJUVANT TREATMENT IN COLON CANCER STAGE II

NCT04120701 | Recruiting Phase 3

• 1 other identifier: PRODIGE 70 - CIRCULATE
• Study Type: interventional
• Target: 1,980
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of CIRCULATE trial is to improve care of patients after colon tumor surgery, based on an innovative marker: circulating tumor DNA.

Conditions

Patients With Resected Stage II Colon Cancer

Outcome Measures

Primary Outcomes (1)

• 3-year Disease-Free Survival in ctDNA positive patients

  3-years

Study Arms (3)

Chemotherapy

EXPERIMENTAL

Drug: mFOLFOX6

Follow-up within the study

NO INTERVENTION

Follow-up outside the study

NO INTERVENTION

Interventions

mFOLFOX6 DRUG

Patients receive adjuvant chemotherapy every 2 weeks during 6 months: FOLFOX6m (5-FU, leucovorin and oxaliplatin).

Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent obtained prior to any study specific procedures
• Age ≥ 18 years and ≤ 75 years
• 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.
• At least 12 lymph nodes analyzed
• Patient with MSI + tumors can be included
• All patients must have been discussed in multidisciplinary meetings with a decision of not performing adjuvant chemotherapy
• No metastatic disease on CT-Scan and/or liver MRI done within 3 months before randomization.
• Randomization planned up to 7 weeks after curative R0 resection
• WHO performance Status \< 2
• No prior chemotherapy for colo-rectal cancer
• No prior abdominal or pelvic irradiation for colo-rectal cancer
• Life expectancy of ≥ 5 years
• Adequate haematological function: with neutrophils ≥ 1,500 /mm3, platelet count ≥ 100,000/mm3, hemoglobin ≥ 9 g/dL (5,6 mmol/l)
• Total bilirubin ≤ 1.5 x ULN (upper limit of normal)
• ASAT and ALAT ≤ 2.5 x ULN

You may not qualify if:

• T4b tumors
• Peripheral neuropathy \> grade 1
• Comorbidity influencing the 5 year patients' survival including clinically relevant cardiovascular disease,
• Ischemic myocardial infarction in the last year and/or unstable ischemic cardiopathy,
• Participation to another interventional study for postoperative therapy
• Partial or complete DPD deficiency
• 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
• 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,
• Lack of effective contraception in patients (men and/or women) of childbearing age, pregnant or breastfeeding women. Women of childbearing potential should agree to use a method of contraception during treatment of the trial and at least 4 months after discontinuation of oxaliplatin therapy and at least 30 days after discontinuation of 5-fluorouracil. Men must agree to use a method of contraception during treatment and at least 6 months after stopping oxaliplatin therapy and at least 3 months after stopping 5-fluorouracil.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Fédération Francophone de Cancérologie Digestive

Dijon, 21000, France

RECRUITING

Central Study Contacts

Julien TAIEB

CONTACT

+33 1 56 09 50 42; julien.taieb@egp.aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 9, 2019
• Study Start: January 17, 2020
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: October 22, 2021

Record last verified: 2021-10

Locations

FR (1)