Status:
ACTIVE_NOT_RECRUITING
TNT to Increase the Clinical Complete Response Rate for Distal LARC
Lead Sponsor:
Sun Yat-sen University
Conditions:
Rectal Cancer
Rectal Cancer Stage II
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is a open-label, single-arm study to investigate the safety and efficacy of total neoadjuvant treatment (TNT) in patients with locally advanced resectable rectal cancer.
Detailed Description
Standard treatment of rectal cancer is neoadjuvant capecitabine chemotherapy with radiotherapy, followed by total mesorectal excision. A new concept suggests organ preservation as an alternative to r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT03840239
Start Date
December 25 2018
End Date
June 30 2027
Last Update
October 25 2023
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060