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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01087658 | Oral Glutamine in the Prevention of Oxaliplatin-induced Neurotoxicity | PHASE3 | COMPLETED | 200 | — | — | Feb 1, 2010 | Mar 1, 2013 | Jun 21, 2013 | 14 | Canada |
| Arm | Type | Description |
|---|---|---|
| Glutamine and calcium magnesium | EXPERIMENTAL | Glutamine 10g p.o. 3-times a day beginning at day -2 for 7 consecutive days during each chemotherapy cycle. 1g of calcium and 1g of magnesium i.v. over 30 minutes just before the chemotherapy and repeated at the same dose after the completion of the oxaliplatine infusion. All patients will receive an oxaliplatin based chemotherapy with XELOX, FOLFOX-4 or mFOLFOX-6. |
| Calcium magnesium | ACTIVE_COMPARATOR | 1g of calcium and 1g of magnesium i.v. over 30 minutes just before the chemotherapy and repeated at the same dose after the completion of the oxaliplatine infusion. All patients will receive an oxaliplatin based chemotherapy with XELOX, FOLFOX-4 or mFOLFOX-6. |
| Name | Type | Description |
|---|---|---|
| Glutamine | DRUG | Per os |
| Calcium and Magnesium | DRUG | Intravenous |
Inclusion criteria: 1. Histologically- or cytologically- proven adenocarcinoma of the colon or rectum. 2. Disease either in adjuvant or 1st line metastatic setting. 3. Eastern Cooperation Oncology Group (ECOG) performance status inferior or equal to 2. 4. At least 4 weeks following any major surgic...