Dataset Information

VECTIBIX PLUS OXALIPLATIN-BASED ADJUVANT TREATMENT OF RECTAL CANCER

ABSTRACT: Primary objectives: To assess the feasibility and preliminary efficacy of adding standard dose panitumumab to standard dose adjuvant FOLFOX4 chemotherapy in patients with resected rectal cancer Primary endpoints: Incidence of unacceptable toxicity (defined as grade 4 adverse event or any toxicity leading to discontinuation of therapy) of the combination of FOLFOX4-panitumumab, as per NCI-CTC guidelines, version 3

DISEASE(S): Rectal Cancer Stage 2-3 Includes Neoadjuvant Chemo Radiation, Followed By Resection, Followed By Adjuvant Chemotherapy.,Colorectal Cancer Stage Ii,Colorectal Cancer Stage Iii

PROVIDER: 2526755 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Primary objectives: ?To establish the efficacy of E-52862 to reduce the incidence and the severity of OXL-induced chronic neuropathy in patients treated for colorectal cancer.?To explore the efficacy of E-52862 to reduce the severity and duration of OXL-induced acute neuropathy.?To evaluate whether E-52862 can raise the cumulative total dose of OXL than can be delivered without dose-limiting chronic neuropathy.?To explore the incidence of dose-reduction, dose-delays and discontinuation of oxaliplatin due to symptomatic neuropathy grade 3 or 4.?To explore the incidence of adverse events by severity, of serious adverse events, of adverse events leading to E 52862 discontinuation and of adverse events related to E-52862 by severity.?To assess E-52862 plasma exposure associated with the treatment. Primary endpoints: Efficacy endpoints:-Evolution of the clinical Total Neuropathy Score (cTNS).-Change from baseline of the reduced Total Neuropathy Score (rTNS).-Evolution of cold-induced pain intensity.-Change from baseline of the number and duration of signs and symptoms of OXL-induced acute neuropathy assessed with the specific OXL-induced neuropathy questionnaire.-Level of peripheral sensory neuropathy toxicity at each visit assessed with the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria.-Time to the first occurrence of NCI-CTCAE grade 2, 3 or 4 symptomatic neuropathy.-Change from baseline of the amplitudes of sensory and motor nerve action potentials and of the sensitive and motor nerve conduction velocities measured in the nerve conduction tests.-Evolution of patients’s quality of life assessed with the Quality of Life Questionnaire C30 (QLQ-C30) with the module for chemotherapy-induced neuropathy (QLQ-CIPN20).-Proportion of patients who meet any of the following definitions of neuropathy at the end of the study: a) at least subclinical neuropathy: cTNS >2, b) manifest neuropathy: rTNS > or equal 5, c) symptomatic neuropathy: grade >1 NCI-CTCAE toxicity, and d) severe neuropathy: grade > or =3 NCI-CTCAE toxicity.-Incidence of dose-reduction, dose-delays and discontinuation of oxaliplatin due to symptomatic neuropathy grade 3 or 4.-Total cumulative dose of OXL administered. Safety endpoitns:-Incidence of adverse events by severity, of serious adverse events, of adverse events leading to E-52862 discontinuation and of adverse events related to E-52862 by severity. Values for these variables will be obtained in all visits of the study, except in the screening visit.-E-52862 plasma concentration associated with the treatment.

Dataset Information

VECTIBIX PLUS OXALIPLATIN-BASED ADJUVANT TREATMENT OF RECTAL CANCER

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