Patients with locally advanced, potentially resectable, Middle-Distal Rectal Carcinoma, stage T3c-d N1-2, MRF + or T4N0-2, EMVI - / + (High-Risk) MedDRA version: 20.0 Level: LLT Classification code 10007464 Term: Carcinoma rectum System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10038052 Term: Rectal carcinoma System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10007446 Term: Carcinoma of rectum System Organ Class: 1000000048
Conditions
Interventions
Product Name: Oxaliplatino
Product Code: [038107037]
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Oxaliplatino
CAS Number: 63121-00-6
Current Sponsor code: Oxalipla
Sponsors
CENTRO DI RIFERIMENTO ONCOLOGICO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adenocarcinoma of the middle distal rectum (up to 12 cm from the anal margin) documented histologically, stage T3c-dN1-2M0, MRF +, T4N0-2M0 (potentially operable), EMVI - / + 2. Age> 18 3. ECOG PS 0-1 4. Measurable disease according to RECIST 1.1 5. Able to understand the risks and benefits of the study 6. Neutrophils >/= 1.5 x 103/µL; Platelets >/= 100 x 103/µL; Bilirubin Tot 50 ml/min or Creatinine /= 2+, perform 24-hour urine collection and verify that the value is 1 neuropathy related to concomitant pathologies. 9. Absence of other malignancies within the last 5 years, except skin cancer and in situ carcinoma of the uterine cervix. 10. Absence of clinically significant heart disease. 11. No pregnancy or breastfeeding in progress. 12. Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 33 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. Previous radiotherapy on the pelvis. 2. Clinically significant (active) cardiovascular disease, e.g. cerebrovascular events (</=6 months), myocardial infarction (</=6 months), unstable angina, congestive decompensation grade II or greater according to New York Heart Association (NYHA), cardiac arrhythmia in therapy. 3. Presence of genotypes with complete DPD enzyme deficiency. 4. Gastrointestinal affections with malabsorption syndrome, impossibility of taking oral medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Determine the rate of Complete Pathological Remissions (pCR) after Chemotherapy Induction, Radiochemotherapy and Chemotherapy Consolidation in patients with High Risk Rectum Carcinoma.;Secondary Objective: - Evaluate the feasibility of the therapeutic program (defined as the percentage of patients able to complete the entire therapeutic program compared to the number of patients enrolled in the study) - Evaluate the rate of Resectability R0 - Evaluate complete and partial clinical remission (ycCR1 and ycPR1) to induction chemotherapy - Evaluate the ycCR2 and ycPR2 after radiochemotherapy and chemotherapy consolidation - Evaluate "Tumor Downstaging", defined as a comparison between clinical staging before and pathological staging after preoperative treatment - Assess the toxicity and safety profile of each therapeutic phase - Assess the morbidity and mortality (Clavien-Dindo) of the surgery postponed to end of the therapeutic program - Evaluate Local Control, DFS and OS at 2-5 years. - Assess the impact of treatment on patients' Quality of Life;Primary end point(s): Define the rate of complete pathological remissions (pCR);Timepoint(s) of evaluation of this end point: 31 July 2028 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): cRRs, RoRate, Fattibilità, OS-DFS;Timepoint(s) of evaluation of this end point: 31 July 2028 | — |
Countries
Italy
Contacts
Public ContactUfficio Clinical Trial
Centro di riferimento oncologico
Outcome results
None listed