Neoadjuvant Chemotherapy followed by Pre-operative Chemoradiation and Consolidation Chemotherapy before Surgery in High Risk Rectal Cancer: Multicentric Phase II Study
Key facts
- Where
- Aviano, Chieti, Padova, Perugia és Roma, OlaszországSee the 5 sites
- Phase
- 2. fázis
Where in Olaszország
- Centro di Riferimento Oncologico di AvianoAviano, OlaszországNo longer taking part
- Universita' Degli Studi G. D'annunzio Di ChietiChieti, OlaszországNo longer taking part
- Istituto Oncologico VenetoPadova, OlaszországNo longer taking part
- Hospital Santa Maria Della MisericordiaPerugia, OlaszországNo longer taking part
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, OlaszországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centro Di Riferimento Oncologico Di Aviano
- Trial code
- EU 2024-517183-31-00
- Record updated
- 2024. szeptember 30.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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; Age > 18; 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: 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; Gastrointestinal disorders with malabsorption syndrome, inability to take drugs through oral administration; Presence of genotypes associated with complete DPD enzyme deficiency.