Status:

RECRUITING

Systemic Oxaliplatin or Intra-arterial Chemotherapy Combined With LV5FU2 +/- Irinotecan and an Target Therapy in First Line Treatment of Metastatic Colorectal Cancer Restricted to the Liver

Lead Sponsor:

Federation Francophone de Cancerologie Digestive

Conditions:

Colorectal Neoplasms

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

Colorectal cancer is the 3rd most common cancer in France and the 2nd cause of death from cancer. Between 30 to 60% of patients develop limited or predominant liver metastases. Surgical resection of t...

Eligibility Criteria

Inclusion

  • Histologically proven colorectal adenocarcinoma with hepatic metastasis(es)
  • At least one measurable hepatic metastasis according to the criteria RECIST v1.1
  • No other metastatic sites except lung nodules if number ≤ 3 and \< 10 mm
  • RAS mutation status known (determination of KRAS mutation (exons 2,3 and 4) and determination of the NRAS mutation (exons 2,3 and 4))
  • Age ≥ 18
  • WHO ≤ 2 (Appendix 4)
  • No prior treatment by chemotherapy except perioperative or adjuvant chemotherapy discontinued for more than 12 months
  • Life expectancy \> 3 months
  • PNN \> 1500/mm3, platelets \> 100 000/mm3, Hb \> 9 g/dLq
  • Bilirubin \< 25 mmol/L, AST \< 5x ULN, ALT \< 5 x ULN, ALP \< 5 x ULN, TP \> 60%, proteinuria from 24H \< 1 g
  • Creatinine clearance \> 50 mL/min according to MDRD formula (Appendix 4)
  • Patient affiliated to a social security scheme
  • Patient information and signature of the informed consent

Exclusion

  • Contraindications specific to the installation of a KTHIA: thrombosis of the hepatic artery, arterial vascular anatomy may compromise a secondary hepatic resection.
  • Patient immediately eligible for a curative therapy (surgical and/or percutaneous) after discussion in CPR
  • Following alterations in the 6 months prior to inclusion: myocardial infarction, angina, severe/unstable angina, coronary artery bypass surgery, congestive heart failure NYHA class II, III or IV, stroke or transient ischemic attack
  • Hypertension not controlled by medical treatment (SBP \> 140 mmHg and/or DBP\> 90 mmHg with blood pressure taken according to the diagram of the HAS)
  • A history of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess or active gastrointestinal bleeding in the 6 months preceding the start of treatment
  • Progressive gastroduodenal ulcer, wound or fractured bone
  • Abdominal or major extra-abdominal surgery (except diagnostic biopsy) or irradiation in the 4 weeks before starting the treatment
  • Transplant patients, HIV positive or other immune deficiency syndromes
  • Any progressive pathology not balanced over the past 6 months: hepatic failure, renal failure, respiratory failure
  • Peripheral neuropathy \> 1
  • Patient with interstitial pneumonitis or pulmonary fibrosis
  • History of chronic diarrhea or inflammatory disease of the colon or rectum, or unresolved occlusion or sub-occlusion in symptomatic treatment
  • History of malignant pathologies during the past 5 years except basocellular skin carcinoma considered in complete remission or in situ cervical carcinoma, properly treated
  • Patient already included in another clinical trial with an experimental molecule
  • Any known specific contraindication or allergy or hypersensitivity to the drugs used in the study (cf RCP Appendix 7)
  • Known deficit in DPD
  • QT/QTc range \> 450 msec for men and \> 470 msec for women
  • K+ \< LNL, Mg2+ \< LNL, Ca2+ \< LNL
  • Lack of effective contraception in patients (men and/or women) of childbearing age, pregnant or breastfeeding women, women of childbearing age not having had a pregnancy test
  • Persons deprived of liberty or under supervision
  • Impossibility of undergoing medical monitoring during the trial for geographic, social or psychological reasons

Key Trial Info

Start Date :

December 1 2016

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2028

Estimated Enrollment :

348 Patients enrolled

Trial Details

Trial ID

NCT02885753

Start Date

December 1 2016

End Date

September 1 2028

Last Update

July 9 2025

Active Locations (49)

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Page 1 of 13 (49 locations)

1

Hôpital Erasme

Brussels, Belgium

2

Chu Hotel Dieu

Angers, France

3

Institut de Cancérologie de l'Ouest

Angers, France

4

Hôpital Privé d'Antony

Antony, France