Exploratory research investigating the impact of the total neoaduvant therapy for locally advanced rectal cancer.

Phase 2

Recruiting

• Conditions: D012004; Rectal Neoplasms; Rectal cancer

• Registration Number: JPRN-jRCTs011220019
• Lead Sponsor: Taketomi Akinobu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

1. The cases histologically diagnosed as rectal adenocarcinoma by endoscopic biopsy.
2. clinical stage II-III by preoperative imaging.
3. The main occupation of the primary tumor site is located middle and lower rectum. (within 12 cm from anal verge)
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 and radiation.
8. Cases of major organ function is maintained.
9. Cases of childbearing potential must consent to the contraception (female, from the consent to 7 weeks after the last chemotherapy; male, from the consent to 15 weeks after the last chemotherapy).
10. Cases with written informed concent.

Exclusion Criteria

1. Double cancer
2. Pregnant or lactating women.
3. Cases with a history of colorectal cancer (Excluding mucosal cancer).
4. Cases with peripheral sensory neuropathy(CTCAE v5.0 Grade 1 or more).
5. Cases with infectious disease requiring systemic therapy.
6. Cases with uncontrolable cardiovascular disease.
7. Cases with a history of mental disorder.
8. HBs-Ag positive, HIV1-Ab positive, HIV2-Ab positive, HTLV1-Ab positive, HCV-Ab positive, HBc-Ab positive with HBV-DNA positive, or HBs-Ab positive with HBV-DNA positive
9. Cases whom the investigators judged as inappropreate for some reasons

Study & Design

• Study Type: Interventional
• Study Design: Not specified