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

  • STATUS
    Recruiting
  • End date
    Jun 25, 2023
  • participants needed
    268
  • sponsor
    Federation Francophone de Cancerologie Digestive
Updated on 25 January 2021
Investigator
Marie Moreau
Primary Contact
CH de Meaux (0.9 mi away) Contact
+106 other location
vegf
fluorouracil
metastasis
oxaliplatin
panitumumab
liver metastasis
EGFR
leucovorin
metastatic colorectal cancer
bevacizumab
systemic chemotherapy
adenocarcinoma
vascular endothelial growth factor
colorectal adenocarcinoma
ki-ras

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 these metastases, only curative treatment is not immediately possible in 10-15% of cases. In unresectable patients, current palliative treatments are based on systemic chemotherapy associated or not with the targeted therapies (anti-EGFR (panitumumab), anti-VEGF (bevacizumab)). In this patient population, special attention was paid to intensified treatment regimens in order to improve their efficiency and improving the tumoral response rate, the intensity of the response and its earliness correlate with improved overall and progression-free survival.

The intra-arterial use of oxaliplatin coupled with IV chemotherapy has yielded OR levels of 64% in patients having survived one or more lines of chemotherapy IV and 62% in patients who have progressed on oxaliplatin IV. In addition, the HIA administration of oxaliplatin limits systemic and especially neurological toxicities, thanks to a greater hepatic clearance.

In conclusion, the combination of systemic chemotherapy, targeted therapy and HIAC with oxaliplatin has showed promising efficacy results associated with good tolerance from the first line onwards. Indeed, we can expect from the Phase II recent data, a control rate close to 100%, with high response rates associated with early maturity and depth responses as well as prolonged survival. However, to date, in the absence of randomized trial testing this combination, this strategy does not have sufficient evidence to be integrated in our routine practices, and HIAC remains limited to a few expert centers in treatment catch-up.

Details
Condition Colorectal Cancer, Rectal disorder, Colon Cancer Screening, Rectal Disorders, Colon cancer; rectal cancer, colorectal neoplasm, cancer, colorectal, colorectal tumor, tumors, colorectal
Treatment Panitumumab, bevacizumab, Folinic Acid, 5 FU, Oxaliplatin intravenous, Oxaliplatin intra-arteriel
Clinical Study IdentifierNCT02885753
SponsorFederation Francophone de Cancerologie Digestive
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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