Neoadjuvant Treatment for Advanced Rectal Carcinoma
France103 participantsStarted 2016-01-07
Plain-language summary
The purpose of the study is to compare pre-operative radio-chemotherapy (RT + capecitabine) to a short course RT associated with a delayed surgery, with two primary objectives: the efficacy evaluation (rate of R0 resection) and the preservation of autonomy (score IADL).
Who can participate
Age range75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient ≥75 years
* Eastern Cooperative Oncology Group (ECOG) ≤2
* Adenocarcinoma of the rectum histologically proven
* Tumor ≤12 cm from the anal margin, the measurement done by rigid rectoscopy or by sub peritoneal MRI
* Require a pre-operative treatment (tumor classified T3 or T4 resectable by MRI and tomodensitometry or T2 of the very low rectum)
* Patient operable
* No radiologically detectable metastases
* Absolute Neutrophile count (ANC) ≥1500/mm³; Platelets ≥100 000/mm³ and Hemoglobin ≥10 g/dL
* Bilirubin ≤1.5 x upper limit of normal (ULN), aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) ≤1.5 x upper limit of normal (ULN), Alkaline Phosphatase ≤1.5 x upper limit of normal (ULN)
* Creatinine clearance ≥30 ml/min (Cockcroft and Gault)
* Uracilemia \< 16ng/mL
* Public or private Health Insurance coverage
* Patient has been informed and signed the informed consent document
Exclusion Criteria:
* Non-resectable tumor
* History of chronic diarrhea or an inflammatory disease of the colon or rectum, or intestinal obstruction or sub-obstruction
* History of pelvic radiotherapy
* Any active febrile infection or any other serious underlying pathology that may prevent the patient from receiving the treatment
* Significant Cardiovascular diseases such as, but not limited to: cardiovascular or myocardial infarction ≤6 months before inclusion, congestive heart failure class II or higher (NYHA), unstable angina, arrhythmia requiring medic…
What they're measuring
1
R0 resection rate
Timeframe: 3 months
2
IADL (Instrumental Activities of Daily Living) Score