Rectal Cancer
Conditions
Interventions
TNT:Total neoadjuvant concommitant chemoradiotherapy
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged from 18-70years; 2. Patients with stage II-III rectal cancer and at least one of the following high risk factors which is diagnosed by MRI or endo-luminal ultrasound: cT4b,cN2,EMVI+,MRF+, lateral LN+; 3. The distance from anal verge is no more than 16cm; 4. Without metastasis; 5. Pathological diagnose is rectal adenocarcinoma; 6. ECOG: 0-1; 7. No prior surgery (except palliative colostomy), radiotherapy or systematic chemotherapy was delivered; 8.Function of main organs are normal: (1) The results of blood tests are normal (HB>=9g/l, N >=1.5*10^9/L, PLT>=100*10^9/l); (2) The results of Blood Biochemistry are normal: Crea, TB <=1.0 folders; ALT, AST<=2.5 folders; 9. No history of allergy to 5-Fu or platium; 10. No prior radiotherapy was delivered to the pelvic; 11. Women of reproductive age must take pregnancy test (serum or urine)in the first seven days, and the result should be negative, and they should be willing to use appropriate methods for contraception during the trials and eight weeks after the treatment. Men should adopt operation sterilization or agree to use appropriate methods for contraception during the trials and eight weeks after the treatment; 12. Patients with good compliance and follow-up should participate in the trial voluntarily and should sign the informed agreement.
Exclusion criteria
Exclusion criteria: 1. Patient who has had the malignant tumor at present or before, except for cured basal cell carcinoma of skin or Cervical carcinoma in situ; 2. Pregnant or lactation women; 3. Serious heart disease, uncontrolled Diabetic; 4. psycologic disease; 5. Seriously or uncontrolled infection; 6. Patients who can not do MRI; 7. During anticoagulant or thrombolystic therapy, or having coagulation disorders, or diagnosed as aneurysm, stroke, TIA, AVM in past year; 8. Patients with history of kidney disease; 9. Patients with history of digestive track fistula, perforation or sever ulcer; 10. Allery to 5-Fu or platium; 11. Participant in another trial in the initial 4 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR;R0 dissection; | — |
Countries
China
Contacts
Public ContactXin Wang
West China Hospital, Sichuan University
Outcome results
None listed