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

JRCT ID: jRCTs011220019

Registered date:27/09/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Rectal cancer
• Date of first enrollment: 27/09/2022
• Target sample size: 55
• Study type: Interventional
• Intervention(s): Intervention of the preoperative chemotherapy (three courses of CapeOX) in localy advanced rectal cancer after the preoperative chemoradiotherapy

Outcome(s)

• Primary Outcome: The rate of complete respose after the neoaduvant therapy (pathological CR+clinical CR)

Secondary Outcome

1) Safety, completion rate, response rate of the neoadjuvant therapy (including clinical complete response), postoperative 30-day complication rate, rate of R0 resection and positive CRM rate
2) Prognosis in eligible cases and that in cases without protocol diviation (overall survival, disease free survival, 3-year cumaltive local recurrence rate)
3) Prognosis after the surgical resecton (overall survival, disease free survival, 3-year cumultive local recurrence rate; overall survival, disease free survival, 3-year cumultive local recurrence rate in each stage)
4) Prognosis after the watch and wait strategy (overall survival, disease free survival, 3-year cumultive local recurrence rate, rate of salvage surgery, disease free survival after the salvage surgery, 3-year cumultive local recurrence rate after the salvage surgery)
5) QOL regarding life satisfaction, peripheral neurological disorder and incontinence, cumaltive rate of stoma, postoperative 3-year complication rate in anastomosis

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Taketomi Akinobu
• Source(s) of Monetary Support: Public Trust Surgery Research Fund