Total Neoadjuvant Therapy in Rectal Cancer

NCT06162650 | Recruiting Phase 2

• 1 other identifier: B-BR-112-042
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

In this phase 2 study, the efficacy of total neoadjuvant therapy in Taiwanese patients with rectal cancer will be investigated. Patients with stage II or III middle/low rectal cancer will be prospective enrolled. The total neoadjuvant therapy with the short-course radiotherapy (5×5 Gy over a maximum of 8 days) followed by chemotherapy with mFOLFOX6 for 9 cycles will be administered. The primary endpoint is the complete response (CR) rate which will take into account the patients with clinical and pathological complete response.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Complete response (CR) rate

  The percentage of patients who achieve a complete response

  The response will be assessed at the period of 2 to 4 weeks after the completion of total neoadjuvant chemotherapy

Secondary Outcomes (5)

• R0 resection rate

  The R0 resection rate will be assessed at the period of 2 to 4 weeks after completion of the total neoadjuvant chemotherapy

• Response rate

  The response will be assessed at the period of 2 to 4 weeks after the completion of total neoadjuvant chemotherapy

• Loco-regional failure rate

  The loco-regional failure will be assessed from the date of surgical resection until the first documented local recurrence, up to 84 months

• Rate of distant metastasis

  The distant metastasis will be assessed from the date of beginning short-course RT until the first documented distant metastasis, up to 84 months

• Safety profiles

  The safety profile will be assessed from the beginning of the short-course RT to the end of last cycle of FOLFOX chemotherapy, up to 24 weeks

Study Arms (1)

Experimental arm

EXPERIMENTAL

The total neoadjuvant therapy with the short-course radiotherapy (5×5 Gy over a maximum of 8 days) followed by chemotherapy with mFOLFOX6 for 9 cycles will be administered.

Radiation: Short-course radiotherapy; Drug: mFOLFOX6

Interventions

Short-course radiotherapy RADIATION

Short-course radiotherapy, 5×5 Gy.

Also known as: RT

Experimental arm

mFOLFOX6 DRUG

Oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, infusinal 5-fluorouracil 2400 mg/m2 every 2 weeks, for 9 cycles

Also known as: Consolidation chemotherapy

Experimental arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of adenocarcinoma of the rectum;
• Tumors located at mid or low rectum (distal extension less than 10 cm from the anal verge);
• Clinical stage II or III (T3/4 and/or N+; no distant metastasis);
• No prior chemotherapy, radiotherapy or surgery for rectal cancer;
• Age ≥20;
• ECOG 0-1;
• Adequate organ function, including followings:
• ANC ≥1,500/μL; Hb ≥8.0 gm/dL; Platelet 100,000/mm3; Total bilirubin ≤1.5x upper normal limit; AST ≤3x upper normal limit; ALT ≤3x upper normal limit; Creatinine ≤1.5x upper normal limit;
• Ability to understand and the willingness to sing a written informed consent.

You may not qualify if:

• Recurrent rectal cancer;
• Patients who have concomitant malignancies, except for adequately treated basal cell carcinoma of the skin or in situ carcinoma of the cervix. Subjects who have prior malignancies and have been disease-free for more than 5 years can be enrolled;
• Patients who have received prior pelvic radiotherapy;
• Patients with active infection requiring intravenous antibiotic treatment;
• Patients with a history of any arterial thrombotic event within the past 6 months, including unstable angina, myocardial infarction (MI) or cerebrovascular accident (CVA), New York Hear Association (NYHA) grade II or greater congestive heart failure, or uncontrolled cardiac arrhythmia;
• Patients with any other concurrent medical or psychiatric condition or disease which, in the investigator's judgement, would make them inappropriate candidates for entry into this study;
• Women who are pregnant or breastfeeding. Women of childbearing potential who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period;
• Patients receiving other anticancer or experimental therapy;
• Known DPD deficiency or hypersensitivity to oxaliplatin;
• Any contraindications to MRI.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Consolidation Chemotherapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Yu-Min Yeh, MD

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Min Yeh, MD

CONTACT

+886 353535; i5485111@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 8, 2023
• Study Start: November 16, 2023
• Primary Completion (Estimated): November 16, 2026
• Study Completion (Estimated): November 16, 2030
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

TW (1)