TNT Versus Conventional CRT to Increase the Sphincter Preservation Rate for Distal LARC

• Status: Recruiting
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: All

Summary

TNT versus. conventional CRT for distal locally advanced rectal cancer (TESS)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Capecitabine; Oxaliplatin

Criteria

Inclusion Criteria:

• Rectal adenocarcinoma

• cT3-4aNany or cTanyN+

• Location ≤5 cm from the anal verge

• No distant metastasis

• No gastrointestinal obstruction or relieved obstruction

• No previous surgery of the rectum, no previous chemotherapy, no previous pelvic radiation, no previous biotherapy

• ECOG 0-1

• Expected survival length ≥ 2 years

• Age 18-70

• Sufficient bone marrow, kidney and liver function

• Effective contraception during the study

• Patient and doctor have signed informed consent

Exclusion Criteria:

• Distant metastasis

• Chronic intestinal inflammation and/or bowel obstruction

• Contra indication for chemotherapy and/or radiotherapy

• Previous pelvic radiotherapy or chemotherapy

• Severe renal, hepatic insufficiency (serum creatinine<30ml/min)

• Peripheral neuropathy > grade 1

• Pregnant or breast-feeding woman

• Certain or suspicious allergy to research drug

• Cachexia, organ dysfunction

• Active severe infection

• Multiple primary cancers

• Epileptic seizures

• Malignant history within 5 years, except cervical carcinoma in situ or cutaneous basal cell carcinoma

• Severe arrhythmia, cardiac dysfunction (NYHA grade III or IV )

• Uncontollable severe hypertesion

• Persons deprived of liberty or under guardianship

• Impossibility for compliance to follow-up