External beam radiotherapy: External beam radiotherapy to the primary tumor, regional lymph nodes and clinical target volume
Surgery: 'Local excision' or 'Intersphincter resection' or 'Total mesorectal excision' or other surgeries
Watch and wait strategy: Watch and wait strategy recommendation and discussion for cCR patients
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Rate of clinical complete response — 1.5 year after diagnosis Rate of clinical complete response
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.