Early Low Rectal Cancer
Conditions
Brief summary
TORCH-E2 is a prospective, multicentre, randomized phase II trial. 134 low-lying early (T1-3b/N0-1M0, distance from anal verge ≤5cm) patients will be recruited and assigned to Group 1 and Group 2 (1:1). Group 1 receives SCRT (25Gy/5Fx) followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody. Group 2 receives LCRT (50Gy/25Fx) followed by 2 cycles of CAPOX. A WW option can be applied to patients achieving cCR while surgery will be recommended for those who fail to achieve cCR. The primary endpoint is complete response (CR, pathological complete response \[pCR\] plus cCR) rate. The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, anal preservation rate, 3-year DFS rate, etc.
Interventions
RADIATIONShort-course radiotherapy
Short-course radiotherapy: 25Gy/5Fx
Toripalimab 240mg d1 q3w
RADIATIONLong-course radiotherapy
Long-course radiation: 50Gy/25Fx
DRUGOxaliplatin
Oxaliplatin: 130mg/m2 d1 q3w
DRUGCapecitabine
Xeloda
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. age 18-75 years old, female and male 2. pathological confirmed adenocarcinoma 3. clinical stage T1-3bN0-1, tumor maximum diameter less than 4cm 4. the distance from anal verge less than 5 cm 5. without distance metastases 6. KPS \>=70 7. with good compliance 8. microsatellite repair status is MSS/pMMR 9. without previous anti-cancer therapy or immunotherapy 10. signed the inform consent
Exclusion criteria
1. pregnancy or breast-feeding women 2. pathological confirmed signet ring cell carcinoma 3. clinical stage T1N0 and can be resected locally 4. history of other malignancies within 5 years 5. serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc. 6. immunodeficiency disease or long-term using of immunosuppressive agents 7. baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN 8. DPD deficiency 9. allergic to any component of the therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complete response (CR) rate | 1 month after the surgery or the decision of W&W | Rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W&W strategy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Organ preservation rate | from date of receiving neoadjuvant therapy, assessed up to 3 years | Organ preservation rate |
| 3 year disease free survival rate | From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months. | Rate of 3 year disease free survival |
| Grade 3-4 adverse effects rate | From date of randomization until 3 months after the completion neoadjuvant therapy | Rate of chemotherapy, radiotherapy and immunotherapy related adverse events |
| 3 year overall survival rate | From date of initiation of treatment until the date of death from any cause, assessed up to 36 months. | Rate of 3 year overall survival |
| 3 year Quality of Life | From date of initiation of treatment until the date of death from any cause, assessed up to 3 years | Quality of life will be evaluated using EORTC QLQ-C30, EORTC QLQ-CR29, LARS score and Wexner score. |
| 3 year local recurrence free survival rate | From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months. | Rate of 3 year local recurrence free survival |
Countries
China
Contacts
Primary ContactZhen Zhang, M.D, PH.D
Backup ContactYajie Chen, PH.D
Outcome results
None listed