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Objectives: This placebo-controlled, randomized, phase III trial is comparing two different infusion schedules for administering calcium gluconate and magnesium sulfate with FOLFOX chemotherapy to determine which is more effective in reducing neurotoxicity in patients receiving the oxaliplatin-based regimen for colon cancer or rectal cancer.
Key entry or exclusion criteria: Patient must have undergone curative resection and is considered to have stage II or III disease or completely resected stage IV disease with no evidence of residual tumor.
Locations: 396 sites .
Goal: 354 patients.
Study sponsor: North Central Cancer Treatment Group in collaboration with the National Cancer Institute.
Link for more information: clinicaltrials.gov/ct2/show/NCT01099449
NIH clinical trials identifier: NCT01099449
Objectives: This placebo-controlled, randomized, phase III trial is comparing two different infusion schedules for administering calcium gluconate and magnesium sulfate with FOLFOX chemotherapy to determine which is more effective in reducing neurotoxicity in patients receiving the oxaliplatin-based regimen for colon cancer or rectal cancer.
Key entry or exclusion criteria: Patient must have undergone curative resection and is considered to have stage II or III disease or completely resected stage IV disease with no evidence of residual tumor.
Locations: 396 sites .
Goal: 354 patients.
Study sponsor: North Central Cancer Treatment Group in collaboration with the National Cancer Institute.
Link for more information: clinicaltrials.gov/ct2/show/NCT01099449
NIH clinical trials identifier: NCT01099449
Objectives: This placebo-controlled, randomized, phase III trial is comparing two different infusion schedules for administering calcium gluconate and magnesium sulfate with FOLFOX chemotherapy to determine which is more effective in reducing neurotoxicity in patients receiving the oxaliplatin-based regimen for colon cancer or rectal cancer.
Key entry or exclusion criteria: Patient must have undergone curative resection and is considered to have stage II or III disease or completely resected stage IV disease with no evidence of residual tumor.
Locations: 396 sites .
Goal: 354 patients.
Study sponsor: North Central Cancer Treatment Group in collaboration with the National Cancer Institute.
Link for more information: clinicaltrials.gov/ct2/show/NCT01099449
NIH clinical trials identifier: NCT01099449