2024-517183-31-00RecruitingPhase 2
Neoadjuvant Chemotherapy followed by Pre-operative Chemoradiation and Consolidation Chemotherapy before Surgery in High Risk Rectal Cancer: Multicentric Phase II Study
Centro Di Riferimento Oncologico Di Aviano5 sites in 1 country93 target enrollmentStarted: September 30, 2024Last updated:
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 93
- Locations
- 5
- Primary Endpoint
- Pathological Complete Remissions (pCR)
Study Overview
Brief Summary
To determine the rate of Pathological Complete Remission (pCR) after Induction Chemotherapy followed by radiochemotherapy and consolidation chemotherapy in patients with High Risk Rectal Carcinoma.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Medial-distal Rectal Adenocarcinoma (up to 12 cm from the anal margin) histologically documented, stage T3c-dN1-2M0, MRF+, T4N0-2MO (potentially resectable), EMVI -/+
- •Absence of clinically significant cardiopathy
- •Absence of pregnancy or ongoing breast-feeding
- •Written informed consent
- •ECOG PS 0-1
- •Measurable disease according to RECIST 1.1
- •Able to comprehend risks and advantages of the study
- •Neutrophils ≥ 1.5x10^3/μL; Platelets ≥ 100x10^3/μL; Total Bilirubin ≤ 1.5 (UNL); ALT and AST ≤ 2.5 UNL, Alkaline Phosphatase ≤ 2.5 UNL; Creatinine clearance >50 ml/min or Creatinine ≤ 1.5 UNL; Proteinuria (stick) <2+ (se ≥ 2+, perform a 24h urine collection and verify that the value is ≤1 g/24 hr).
- •Absence of mutational state with complete deficit of dihydropyrimidine dehydrogenase (DPD) enzyme; presence of mutations associed with partial DPD deficit does not exclude patient eligibility (Fluoropyrimidine dose reduction is expected)
- •Absence of neuropathy grade > 1 associated to concomitant illnesses
- •Absence of other malignancies within the last 5 years, except for skin carcinoma and carcinoma in situ of the cervix.
Exclusion Criteria
- •Previous radiotherapy on the pelvis
- •Clinically significant (active) cardiovascular disease, eg. cerebrovascular events (≤6 months), myocardial infarction (≤6 months), unstable angina, congestive decompensation of grade II or higher according to New York Heart Association (NYHA), cardiac arrhythmia under therapy.
- •Presence of genotypes associated with complete DPD enzyme deficiency
- •Gastrointestinal disorders with malabsorption syndrome, inability to take drugs through oral administration
Outcomes
Primary Outcomes
Pathological Complete Remissions (pCR)
Pathological Complete Remissions (pCR)
Secondary Outcomes
No secondary outcomes reported
Investigators
Marco Gigante
Scientific
Centro Di Riferimento Oncologico Di Aviano
Study Sites (5)
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