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Compare two treatment regimens to find out whether one of them FOLFIRI is better than the other Irinotecan alone when combined with Arsenic trioxide

ABSTRACT: Intervention1: modified FOLFIRI plus Arsenic trioxide: Irinotecan 180mg per m2 IV over 90 mins on Day 1 Leucovorin 300mg per m2 IV over 2 hours on Day 1 5 FU - 2400mg per m2 IV over 46 hours continuous infusion starting on Day 1 Arsenic Trioxide 0.15mg per kg IV in 250 ml NS over two hours 1st dose on Days 1 and 2 1 cycle, administered every 2 weeks Start of next IV cycle on D 15 If ATO is well tolerated during the first infusion, then it can be infused over 1 hour from the second dose onwards. Control Intervention1: Irinotecan monotherapy: Irinotecan 180 mg per m2 IV over 90 mins on Day 1 1 cycle, administered every 2 weeks Start of next IV cycle on D 15 The patient will be on supportive care and reviewed with imaging and serologically on a periodic basis, every 3 months + or -15 days as per study or on an SOS basis in case of symptomatic disease worsening Primary outcome(s): Progression free survivalTimepoint: 5 years Study Design: Other Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Open Label

DISEASE(S): Malignant Neoplasm Of Rectum

PROVIDER: 2738867 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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