eoadjuvant FOLFOX in rectal cancer

Phase 2

• Conditions: locally advanced rectal cancer

• Registration Number: JPRN-jRCTs011180028
• Lead Sponsor: Taketomi Akinobu

Brief Summary

The operations after the 4 courses of preoperative mFOLFOX6 was safe and promising strategy to improve the prognosis in locally advanced rectal cancer.

Detailed Description

Not available

Study Timeline

• Results First Posted: 2019-03-05
• Study Start: 2019-03-25
• Study Completion: 2020-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

1. The cases histologically diagnosed as rectal cancer by endoscopic biopsy.
2. clinical stage-II or III by preoperative imaging.
3. The main occupation of the primary tumor site is located upper of lower rectum.
4. The age is 20 years old and older and under 75 years old.
5. Performance Status(ECOG) is 0 or 1.
6. No history of surgical treatment for primary tumor.
7. Cases without a history of chemotherapy, radiation, and so on.
8. Cases of major organ function is maintained.

Exclusion Criteria

1. Double cancer
2. Pregnant or lactating women.
3. Patients with a history of colorectal cancer(Excluding mucosal cancer).
4. Patients with peripheral sensory neuropathy(CTCAE v4.0> Grade 1).
5. Patients with infectious disease requiring systemic therapy.
6. Patients with uncontrolable cardiovascular disease.
7. Patients with a history of mental disorder.

Study & Design

• Study Type: Interventional
• Study Design: Not specified