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Phase II Randomized Study Comparing the Association of Intraarterial Perfusion of Raltitrexed and Oxaliplatin Versus Oral Capecitabine and Mitomycin Using Intravenous Perfusion for Colorectal Cancer Patient With Metastases Localized to Liver After Failure of Conventional Treatments.


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Colorectal Cancer, Liver Metastases

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Trial Information

Phase II Randomized Study Comparing the Association of Intraarterial Perfusion of Raltitrexed and Oxaliplatin Versus Oral Capecitabine and Mitomycin Using Intravenous Perfusion for Colorectal Cancer Patient With Metastases Localized to Liver After Failure of Conventional Treatments.


Inclusion Criteria:



- Informed consent signature by the patient-

- Cover by an health insurance

- Age between 18 and 75 years

- WHO status of 0 or 1

- Estimated Life expectancy > 3 months

- Hepatic metastases of colorectal cancer confirmed on CT Scan without extra-hepatic
metastasis (the presence of asymptomatic primary tumor is tolerated)

- TEP-Scan without fixation outside the liver and the primary tumor

- Histological proven colorectal cancer obtained from primary tumor or the hepatic
metastases

- Metastases not accessible to curative hepatectomy (impossible R0 surgery or leaving
less than 30 % of residual liver), or requiring a complex, very wide hepatectomy (5
segments or more) and\or risky procedure (RPC Class II)- - Presence of hepatic
lesion > 10 mm on CTScan or hepatic MRI

- Failure or arrest of a previous chemotherapy because of intolerance to oxaliplatin,
irinotecan, a fluoropyrimidine and/or target therapies (bevacizumab, cetuximab or
panitumumab given for tumor expressing wild type Ki-Ras)

- Bilirubinemia< 1,5 times the superior limit of the normal ( N ),

- ASAT and ALAT < 5 N,

- Creatinemia < 1.5 N and creatinine clearance > 65ml/mn,

- Neutrophils > 1,5 x 109/L, platelets 100 x 109/L, hemoglobin > 9 g/dL (patients
includables even after red blood cell transfusion)-Reference CTScan +/-MRI performed
in 21 days preceding the first cycle of treatment

Exclusion Criteria:

- extra-hepatic metastases (presence of 1 to 3 pulmonary nodules, of a maximal diameter
of 5 mm with non specific aspect on CTScan and with no fixation on TEP Scan does not
constitute a criterion of exclusion)

- Symptomatic primary colorectal tumor in place

- Contraindication for allergy of rank 3-4 for one of the compounds of chemotherapy-
Peripheral neuropathy > 2 (Levy Scale)

- Current participation or in the 30 days preceding the inclusion in the study in
another therapeutic trial with an experimental molecule

- Concomitant systemic treatment by immunotherapy, chemotherapy or hormonotherapy-
Unbalanced serious illness, unchecked active infection or the other underlying
serious disorder susceptible to prevent the patient from receiving the treatment

- Pregnancy (pregnancy test compulsory for the inclusion), breast-feeding

- Intestinal occlusion or sub-occlusion or history of inflammatory intestinal disease

- Other cancer during the 5 years preceding entry in the trial or concomitant (except
in situ cancer of the cervix or skin basal cell carcinoma)Patient in custody or under
guardianship, Impossibility to adhere to the medical follow-up for geographical,
social or psychiatric reason

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression-free survival

Outcome Time Frame:

for each patient after the 6 months of treatment

Safety Issue:

No

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

0329-1ghfr09

NCT ID:

NCT01348412

Start Date:

December 2010

Completion Date:

December 2014

Related Keywords:

  • Colorectal Cancer
  • Liver Metastases
  • non resectable metastases
  • liver of colic or rectal origin
  • after failure of the conventional treatments
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Liver Neoplasms

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