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Trial record 1 of 1 for:    prodige49 oscar
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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 (OSCAR)

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ClinicalTrials.gov Identifier: NCT02885753
Recruitment Status : Recruiting
First Posted : August 31, 2016
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Federation Francophone de Cancerologie Digestive

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 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.


Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Drug: Oxaliplatin intravenous Drug: 5 Fu Drug: Folinic Acid Drug: Oxaliplatin intra-arteriel Drug: Panitumumab Drug: Bevacizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Arm Intervention/treatment
Experimental: Experimental arm with oxaliplatin intra-arterial
Panitumumab (6 mg/kg if RAS wild) or Bevacizumab (5 mg/Kg if RAS mutated) Oxaliplatin (85 mg/m²) intra-arterially Folinic Acid (400 mg/m²) intravenously 5Fu: 400 mg/m² in bolus of 10 minutes 5Fu: 2400 mg/m² intravenously over 46 hours
Drug: 5 Fu
5 fluorouracil : 400 mg/m² in bolus of 10 minutes (intravenous) following by 2400 mg/m² during 46 hours in intravenous

Drug: Folinic Acid
400 mg/m² in intravenous

Drug: Oxaliplatin intra-arteriel
85 mg/m² in intra-arterial. 1 cycle each 15 days

Drug: Panitumumab
Only for patient RAS wild: 6 mg/Kg at each cycle in intravenous

Drug: Bevacizumab
Only for patient RAS mutated : 5 mg/m² at each cycle in intravenous

Active Comparator: Reference arm with oxaliplatin intravenous
Panitumumab (6 mg/kg if RAS wild) or Bevacizumab (5 mg/Kg if RAS mutated) Oxaliplatin (85 mg/m²) intravenously Folinic Acid (400 mg/m²) intravenously 5Fu: 400 mg/m² in bolus of 10 minutes 5Fu: 2400 mg/m² intravenously over 46 hours
Drug: Oxaliplatin intravenous
85 mg/m² in intravenous. 1 cycle each 15 days

Drug: 5 Fu
5 fluorouracil : 400 mg/m² in bolus of 10 minutes (intravenous) following by 2400 mg/m² during 46 hours in intravenous

Drug: Folinic Acid
400 mg/m² in intravenous

Drug: Panitumumab
Only for patient RAS wild: 6 mg/Kg at each cycle in intravenous

Drug: Bevacizumab
Only for patient RAS mutated : 5 mg/m² at each cycle in intravenous




Primary Outcome Measures :
  1. hepatic progression-free survival [ Time Frame: 24 months after randomization ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02885753


Contacts
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Contact: Marie MOREAU +33 (0)380393404 marie.moreau@u-bourgogne.fr

Locations
Show Show 33 study locations
Sponsors and Collaborators
Federation Francophone de Cancerologie Digestive
Investigators
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Principal Investigator: Julien TAIEB, MD-PhD HEGP, Paris

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Responsible Party: Federation Francophone de Cancerologie Digestive
ClinicalTrials.gov Identifier: NCT02885753    
Other Study ID Numbers: PRODIGE 49
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Federation Francophone de Cancerologie Digestive:
colorectal
cancer
metastasis
hepatic
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Folic Acid
Bevacizumab
Panitumumab
Oxaliplatin
Levoleucovorin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antidotes
Protective Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients