TNT to Increase the Clinical Complete Response Rate for Distal LARC (NCT03840239) | Clinical Trial Compass
Active — Not RecruitingPhase 2
TNT to Increase the Clinical Complete Response Rate for Distal LARC
China98 participantsStarted 2018-12-25
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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