A Phase II Study of Total Neoadjuvant Therapy in Rectal Cancer
Overview
- Phase
- Phase 2
- Intervention
- Short-course radiotherapy
- Conditions
- Rectal Cancer
- Sponsor
- National Cheng-Kung University Hospital
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Complete response (CR) rate
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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
Investigators
Yu-Min Yeh
MD
National Cheng-Kung University Hospital
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;
- •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;
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: Short-course radiotherapy
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.
Intervention: mFOLFOX6
Outcomes
Primary Outcomes
Complete response (CR) rate
Time Frame: The response will be assessed at the period of 2 to 4 weeks after the completion of total neoadjuvant chemotherapy
The percentage of patients who achieve a complete response
Secondary Outcomes
- 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)
- 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)
- Response rate(The response will be assessed at the period of 2 to 4 weeks after the completion of total neoadjuvant chemotherapy)
- 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)