The pilot study on surgical safety after neoadjuvant chemotherapy of mFOLFOX6 for locally advanced rectal cancer.

The pilot study on surgical safety after neoadjuvant chemotherapy of mFOLFOX6 for locally advanced rectal cancer. - The pilot study on surgical safety after neoadjuvant chemotherapy for locally advanced rectal cancer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012559

Enrollment

Registered

2013-12-14

Start date

2013-12-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

locally advanced rectal cancer

Interventions

preoperative chemotherapy (4 courses of mFOLFOX6)

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
percentage of postoperative complications	—

Secondary

Measure	Time frame
Response rate by preoperative chemotherapy, the safety of preoperative chemotherapy, local recurrence rate, disease-free survival	—

Countries

Japan

Contacts

Public ContactNorihiko Takahashi

Hokkaido University Hospital Gastroenterological Surgery I

noripiko@med.hokudai.ac.jp011-706-5927

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026