Total Neoadjuvant Treatment Without Surgery For Locally Advanced Rectal Cancer (NCT03565029) | Clinical Trial Compass
CompletedPhase 2
Total Neoadjuvant Treatment Without Surgery For Locally Advanced Rectal Cancer
Italy180 participantsStarted 2018-06-01
Plain-language summary
NO-CUT is a one-stage phase II trial seeking to establish whether an oxaliplatin-based chemotherapy preceding standard neo-adjuvant fluoropyrimidines-based chemo radiotherapy, can safely spare demolitive surgical intervention in patients with operable rectal cancer, without increasing the risk of distant relapse. The trial also has a translational component aimed at establishing whether selected genomic, epigenetic, and transcriptomic markers are predictive of tumor and patient outcome.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically confirmed diagnosis of adenocarcinoma of the medium/lower rectum
* Patients must have Stage II (cT3-4 N0) or Stage III (cT1-4, N1-3) tumor
* Locally advanced rectal cancer amenable to Total Mesorectal Excision (TME)/Abdominal-Perineal Amputation
* No evidence of distant metastases by chest, abdomen, and pelvis contrast enhanced CT scan (TC-positron emission computed tomography (PET) Whole Body (WB) is acceptable alternative in patient allergic to iodate contrast medium)
* No prior pelvic radiation therapy
* No prior oncologic medical therapy or surgery for rectal cancer
* Age \>18 years
* No infections requiring systemic antibiotic treatment
* Performance status 0-1 (ECOG Scale)
* absolute neutrophil count (ANC) \> 1.5 cell/mm3, Hb\>8.0 g/ dL, Platelet Count (PLT)\>150,000/mm3, total bilirubin \< or equal or 1.5 x upper limit of normal, Aspartate Aminotransferase (AST) \< or equal to three times upper limit of normal, Alanine Aminotransferase (ALT)\< or equal to three times upper limit of normal; Serum creatinine level \< or equal to 1.5 times the upper limit of normal
* Patients must read, agree to, and sign a statement of Informed Consent prior to participation
* Women with childbearing potential who are negative for pregnancy test (urine or blood) and who agree to use effective contraceptive methods
* Male subjects must also agree to use effective contraception
Exclusion Criteria:
* Recurrent rectal cancer
* Patients with a history o…