TOTAL NEOADJUVANT TREATMENT WITHOUT SURGERY FOR LOCALLY ADVANCED RECTAL CANCER: PROSPECTIVE CLINICAL TRIAL TO ASSESS TUMOR COMPLETE RESPONSE, CIRCULATING TUMOR GENETIC AND EPIGENETIC BIOMARKERS, AND STROMAL TRANSCRIPTOME TO INTERPRET CLINICAL OUTCOME (NO-CUT TRIAL)

Phase 1

Conditions: Adenocarcinoma of the medium/lower rectum in Stage II (cT3-4 N0) or Stage III (cT1-4, N1-2)
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2024-515225-28-00

Lead Sponsor: ASST Grande Ospedale Metropolitano Niguarda

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 180

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, N1-2) 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-PET 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) - ANC > 1.5 cell/mm3, Hb>8.0 g/ dL, PLT>150,000/mm3, total bilirubin < or equal or 1.5 x upper limit of normal, AST < or equal to three times upper limit of normal, 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 of any arterial thrombotic event within the past 6 months, including angina (stable or unstable), MI, or CVA - Intolerance or contraindication to MR procedure - Patients with any other concurrent medical or psychiatric condition that are unstable or could jeopardize the safety of the patient and his/her compliance in the study - Gastro-intestinal abnormalities, inability to take oral medication, any condition affecting absorption - Patients with a history of a prior malignancy within the past 5 years, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer. - Patients with a history of thrombotic episodes, such as deep venous thrombosis, pulmonary embolus, MI, or CVA occurring more than 6 months prior to enrollment may be considered for protocol participation, provided they are on stable doses of anticoagulant therapy. Patients who are anticoagulated for atrial fibrillation or other conditions may participate, provided they are on stable doses of anticoagulant therapy. - Patients receiving other anticancer or experimental therapy.