Total Neoadjuvant Therapy in Rectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Short-course radiotherapy, mFOLFOX6.
- Who it may be relevant to
- Registry conditions: Rectal Cancer. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase II Study of Total Neoadjuvant Therapy in Rectal Cancer
Overview
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
Interventions
- Radiation Short-course radiotherapy
Short-course radiotherapy, 5×5 Gy. - Drug mFOLFOX6
Oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, infusinal 5-fluorouracil 2400 mg/m2 every 2 weeks, for 9 cycles
Primary outcome measures
- 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]
Secondary outcome measures (5)
- R0 resection rate [Time frame: The R0 resection rate will be assessed at the period of 2 to 4 weeks after completion of the total neoadjuvant chemotherapy]
- Response rate [Time frame: The response will be assessed at the period of 2 to 4 weeks after the completion of total neoadjuvant chemotherapy]
- Loco-regional failure rate [Time frame: 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 [Time frame: 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 [Time frame: 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- National Cheng Kung University Hospital — Tainan
Identifiers
NCT: NCT06162650 · B-BR-112-042