Total Neoadjuvant Therapy in Rectal Cancer

NCT ID: NCT06162650

Last Updated: 2023-12-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-16
• Study Completion Date: 2030-11-16

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.

Detailed Description

This is a single center, single-arm, open-label, phase II study to investigate the efficacy and toxicities of total neoadjuvant therapy in patients with middle or lower rectal cancer. This study is planned to start after the approval by IRB, enroll patients for 2 years, and follow the clinical outcome for another 5 years. It will be conducted at National Cheng Kung University Hospital. Forty-two subjects will be enrolled. Patients who have newly diagnosed stage II or III, middle or low rectal adenocarcinoma will be recruited to receive the TNT treatment. The TNT includes the short-course radiotherapy (5×5 Gy over a maximum of 8 days)) followed by chemotherapy with the regimen of mFOLFOX6 for total 9 cycles

Conditions

Rectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental arm

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.

Group Type: EXPERIMENTAL

Short-course radiotherapy

Intervention Type: RADIATION

Short-course radiotherapy, 5×5 Gy.

mFOLFOX6

Intervention Type: DRUG

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

Interventions

Short-course radiotherapy

Short-course radiotherapy, 5×5 Gy.

Intervention Type: RADIATION

mFOLFOX6

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

Intervention Type: DRUG

Other Intervention Names

RT; Consolidation chemotherapy

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cheng-Kung University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yu-Min Yeh

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yu-Min Yeh, MD

Role: PRINCIPAL_INVESTIGATOR

National Cheng-Kung University Hospital

Locations

National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yu-Min Yeh, MD

Role: CONTACT

Phone: +886 353535

Email: i5485111@gmail.com

Facility Contacts

Yu-Min Yeh, MD

Role: primary

Other Identifiers

B-BR-112-042

Identifier Type: -

Identifier Source: org_study_id