Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00582426 | Evaluation of Octreotide LAR in Prevention of Chemotherapy-induced Diarrhea | PHASE3 | COMPLETED | 139 | — | — | Apr 1, 2008 | Sep 1, 2010 | May 4, 2015 | 11 | Brazil |
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.
| Arm | Type | Description |
|---|---|---|
| Octreotide Long Acting Release | EXPERIMENTAL | Prevention of Chemotherapy Induced Diarrhea (CID) |
| Standard Treatment | OTHER | Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR. |
| Name | Type | Description |
|---|---|---|
| Octreotide Long Acting Release | DRUG | Patients 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 first-line chemotherapy is discontinued or for a maximum of six doses of Octreotide LAR, whichever occurs first. |
| Standard Treatment | OTHER | Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR. |
Inclusion criteria: 1. Providing a written informed consent 2. Age between 18 and 80 years; 3. Histological diagnosis of colorectal cancer, presence of metastatic disease and no prior systemic therapy for metastatic disease (prior adjuvant therapy will be allowed if completed 6 months or longer bef...