Informations générales (source: ClinicalTrials.gov)
CIRCULATING TUMOR DNA BASED DECISION FOR ADJUVANT TREATMENT IN COLON CANCER STAGE II
Interventional
Phase 3
Centre Hospitalier Universitaire Dijon (Voir sur ClinicalTrials)
janvier 2020
janvier 2028
15 septembre 2025
The objective of CIRCULATE trial is to improve care of patients after colon tumor
surgery, based on an innovative marker: circulating tumor DNA.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | L�onor BENHAIM | 10/04/2024 12:36:56 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| HOPITAL FOCH | lundi 15 septembre 2025 | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Fédération Francophone de Cancérologie Digestive - 21000 - Dijon - France | Flore GEILLON | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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
- Alkaline phosphatase ≤ 2.5 x ULN
- Serum creatinine ≤ 120 µmol/L or creatinine clearance ≥50 ml/min according MDRD
(Modification of Diet in Renal Disease)
- Carcinoembryogenic antigen (CEA) ≤ 1.5 x ULN after surgery (during screening period)
- Negative pregnancy test for registration(for women of childbearing age)
- Patient affiliated to a social security system
- 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
- Alkaline phosphatase ≤ 2.5 x ULN
- Serum creatinine ≤ 120 µmol/L or creatinine clearance ≥50 ml/min according MDRD
(Modification of Diet in Renal Disease)
- Carcinoembryogenic antigen (CEA) ≤ 1.5 x ULN after surgery (during screening period)
- Negative pregnancy test for registration(for women of childbearing age)
- Patient affiliated to a social security system
- 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.