The feasibility study of FOLFOX therapy in gastrointestinal cancer patients undergoing hemodialysis

JRCT ID: jRCTs051190120

Registered date:11/03/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer, gastric cancer, small bowel cancer, colorectal cancer
• Date of first enrollment: 23/03/2020
• Target sample size: 15
• Study type: Interventional
• Intervention(s): FOLFOX therapy

Outcome(s)

Primary Outcome

Part1 : Recommended starting dose
Part2: Completion rate of chemotherapy

• Secondary Outcome: Overall survival, Response rate, incidence of adverse events

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1. Patients undergoing hemodialysis.
2. Patients diagnosed as gastrointestinal cancer.
3. Less than 80years old, and PS is 0-1.
4. Organ functions other than renal function are maintained.
5. Chemotherapy naive case.
6. The written consent can be obtained from patients.

Exclude criteria

1. Hyperammonemia within 14 days befere registration.
2. Patients with Grade 2 peripheral sensory neuropathy.

Related Information

• Primary Sponsor: Manabu Muto
• Source(s) of Monetary Support: Grant-in-Aid for Scientific Research