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

Phase 2

Not yet recruiting

• Conditions: High Risk Rectal Cancer

• Registration Number: 2024-517183-31-00
• Lead Sponsor: Centro Di Riferimento Oncologico Di Aviano

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.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-09-30
• Last Update Posted: 2024-09-30

Recruitment & Eligibility

• Status: Authorised, recruitment pending
• Sex: Not specified
• Target Recruitment: 93

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

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 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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Pathological Complete Remissions (pCR)		Pathological Complete Remissions (pCR)

Trial Locations

Locations (5)

Universita' Degli Studi G. D'Annunzio Di Chieti; 🇮🇹 Chieti, Italy

Centro Di Riferimento Oncologico Di Aviano; 🇮🇹 Aviano, Italy

Istituto Oncologico Veneto; 🇮🇹 Padova, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS; 🇮🇹 roma, Italy

Hospital Santa Maria Della Misericordia; 🇮🇹 Perugia, Italy

Universita' Degli Studi G. D'Annunzio Di Chieti

🇮🇹Chieti, Italy

Domenico Genovesi

Site contact

0871357482

d.genovesi@unich.it