Clinical trial · Interventional
Total Neoadjuvant Therapy in Rectal Cancer
A Phase II Study of Total Neoadjuvant Therapy in Rectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mFOLFOX6 | Drug | — | UNRESOLVED |
| Short-course radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental arm
- description
- 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.
- interventionNames
- Radiation: Short-course radiotherapy
- Drug: mFOLFOX6
Primary outcomes (1)
- measure
- Complete response (CR) rate
- timeFrame
- The response will be assessed at the period of 2 to 4 weeks after the completion of total neoadjuvant chemotherapy
- description
- The percentage of patients who achieve a complete response
Secondary outcomes (5)
- measure
- R0 resection rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available