LARCID: Evaluation of Octreotide LAR in Prevention of Chemotherapy-induced Diarrhea
Eligible patients will have a diagnosis of colorectal cancer, and will be candidates to
adjuvant chemotherapy or first-line chemotherapy for metastatic disease with a regimen
containing fluorouracil, capecitabine and/or irinotecan. Eligible chemotherapy regimens
include Irinotecan, Leucovorin (folinic acid), and Fluorouracil(IFL), Leucovorin,
Fluorouracil, and Irinotecan (FOLFIRI), combinations of Irinotecan and Capecitabine, the
Roswell Park regimen and the Mayo Clinic regimen, all of them without or with Oxaliplatin,
Bevacizumab or Cetuximab. Patients receiving Erlotinib, or other Tyrosine-kinase, Epidermal
Growth Factor Receptor (EGFR)-inhibitors, will not be eligible.
The acute treatment for diarrhea will be left to physician's discretion in both groups.
Patients in the control arm will be treated without Octreotide LAR. Patients in the
experimental arm will receive the first dose of Octreotide LAR (30 mg) at chemotherapy
initiation, in addition to a minimum of two more identical monthly doses of Octreotide LAR
(with an interval of 28 days between them), until chemotherapy is discontinued or for a
maximum of six doses of Octreotide LAR, whichever occurs first. Patient evaluation will be
done at each cycle for efficacy and toxicity.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Percentage of Participants Developing Diarrhea (Grade 1 to 4)
The percentage of patients developing diarrhea (incidence of grade 1 to 4) during treatment, considering only the worst grade of diarrhea for each patient. Diarrhea was graded according to Common Toxicity Criteria where Grade 0=None, 1 = Increase of <4 stools/day over pretreatment, Grade 2 = Increase of 4-6 stools/day, or nocturnal stools, Grade 3 = Increase of ≥7 stools/day or incontinence; or need for parenteral support for dehydration and Grade 4= Physiologic consequences requiring intensive care; or hemodynamic collapse.
6 month overall
Brazil: ANVISA Agência Nacional de Vigilância Sanitária