OXALIPLATIN for Rectal adenocarcinoma | Locally advanced rectal cancer

Inclusion criteria

• {"criterion_text":"- Histologically confirmed diagnosis of adenocarcinoma of the medium/lower rectum\n- Patients must have Stage II (cT3-4 N0) or Stage III (cT1-4, N1-2) tumor\n- Locally advanced rectal cancer amenable to Total Mesorectal Excision (TME)/Abdominal-Perineal Amputation\n- 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)\n- No prior pelvic radiation therapy\n- No prior oncologic medical therapy or surgery for rectal cancer\n- Age >18 years\n- No infections requiring systemic antibiotic treatment\n- Performance status 0-1 (ECOG Scale)\n- 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\n- Patients must read, agree to, and sign a statement of Informed Consent prior to participation\n- Women with childbearing potential who are negative for pregnancy test (urine or blood) and who agree to use effective contraceptive methods\n- Male subjects must also agree to use effective contraception"}

Exclusion criteria

• {"criterion_text":"- Recurrent rectal cancer\n- Patients with a history of any arterial thrombotic event within the past 6 months, including angina (stable or unstable), MI, or CVA\n- Intolerance or contraindication to MR procedure\n- 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\n- Gastro-intestinal abnormalities, inability to take oral medication, any condition affecting absorption\n- 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.\n- 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.\n- Patients receiving other anticancer or experimental therapy."}

Primary endpoints

• {"endpoint_text":"- Distant Relapse-Free Survival (DRFS) rate at 2.5 year\n- Association between 6-methylated gene panel and hazard ratio (HR) for relapse free survival\n- Association between ctDNA and relative hazard per standard deviation unit (HRσ)\n- Association between stromal score and odds ratio of response to treatment","definition_or_measurement_approach":"Distant Relapse-Free Survival (DRFS) rate measured at 2.5 years; associations of biomarker measures with time-to-event outcomes using hazard ratios for relapse-free survival (6-methylated gene panel and ctDNA) and odds ratio of response for stromal score as specified in protocol."}

Secondary endpoints

• {"endpoint_text":"- Clinical complete response rate\n- Local recurrence and organ preservation rate, colostomy-free survival\n- Overall survival\n- Patient reported outcomes (European Organization for Research and Treatment of Cancer [EORTC] QLQ-C30 and its colorectal cancer specific module QLQ-38)","definition_or_measurement_approach":"Clinical complete response rate (proportion of patients achieving clinical complete response); local recurrence, organ preservation rate and colostomy-free survival (rates/time-to-event); overall survival (time-to-death from any cause); patient-reported outcomes measured using EORTC QLQ-C30 and colorectal cancer-specific module QLQ-38."}

Italy

Earliest CTIS Part Ii Submission Date

06-06-2024

Latest Decision Or Authorization Date

05-08-2024

Processing Time Days

60

Number Of Sites

4

Number Of Participants

180

Primary sponsor

Full Name

ASST Grande Ospedale Metropolitano Niguarda

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Contract research organisations

Name

Advice Pharma Group S.r.l.

Responsibilities

CRO

Third parties

• {"country":"Italy","full_name":"Advice Pharma Group S.r.l.","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}