eoadjuvant Chemotherapy followed by Pre-operative Chemoradiation and Consolidation Chemotherapy before Surgery in High Risk Rectal Cancer: Multicentric Phase II Study.

Phase 1

• Conditions: Patients with locally advanced, potentially resectable, Middle-Distal Rectal Carcinoma, stage T3c-d N1-2, MRF + or T4N0-2, EMVI - / + (High-Risk); MedDRA version: 20.0Level: LLTClassification code 10007464Term: Carcinoma rectumSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10038052Term: Rectal carcinomaSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10007446Term: Carcinoma of rectumSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-002727-11-IT
• Lead Sponsor: CENTRO DI RIFERIMENTO ONCOLOGICO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-17
• Last Update Posted: 11 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 93

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 (stick) <2+ (if >/= 2+, perform 24-hour urine collection and verify that the value is 7. Absence of mutational state with complete deficiency of the enzyme dihydropyrimidine dehydrogenase (DPD); the presence of mutations associated with partial DPD deficit does not exclude eligibility (expected dose reduction of Fluoropyrimidine; see 7.1)
8. Absence of Grade> 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

1. Previous radiotherapy on the pelvis.
2. Clinically significant (active) cardiovascular disease, e.g. cerebrovascular events (3. Presence of genotypes with complete DPD enzyme deficiency.
4. Gastrointestinal affections with malabsorption syndrome, impossibility of taking oral medications.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified