Multicentre, open-label, randomized, controlled, parallel arms clinical trial of induction chemotherapy followed by chemoradiotherapy versus chemoradiotherapy alone as neoadjuvant treatment for locally recurrent rectal cancer (PelvEx II)

Phase 1

Recruiting

• Conditions: ocally recurrent rectal cancer; MedDRA version: 21.0Level: PTClassification code: 10038046Term: Rectal cancer recurrent Class: 100000004864; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2024-512526-28-00
• Lead Sponsor: Catharina Ziekenhuis Stichting

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-18
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 364

Inclusion Criteria

18 years or older, Confirmed locally recurrent rectal cancer after total or partial mesorectal resection for rectal cancer or distal sigmoidal cancer, either by; histopathology ór; clinically proven (evidence on imaging in combination with clinical findings, with consensus in MDT), Resectable disease determined by magnetic resonance imaging (MRI) or deemed resectable after neoadjuvant treatment with chemoradiotherapy. Expected gross incomplete resection with overt tumour remaining in the patient after resection, encasement of the ischiadic nerve and invasion of the cortex and/or neuroforamina from S2 and upwards are considered not resectable., WHO performance score 0-1, Written informed consent

Exclusion Criteria

Radiological evidence of metastatic disease (e.g. liver, lung) at time of randomisation or in the six months prior to randomisation. Patients with enlarged iliac lymph nodes, enlarged inguinal lymph nodes and aspecific lung noduli are not excluded from inclusion., Homozygous DPD deficiency (if known in advance), Any chemotherapy in the past 6 months., Radiotherapy in the past 6 months for primary rectal cancer., Any contraindication for the planned chemotherapy (e.g. severe allergy, pregnancy, kidney dysfunction, thrombocytopenia), as determined by the medical oncologist., Any contraindication for the planned chemoradiotherapy (e.g. severe allergy to chemotherapy agent, no possibility for radiotherapy due to previous radiotherapy), as determined by the medical oncologist and/or radiation oncologist., Any contraindication for surgery, as determined by the surgeon and/or anaesthesiologist., Concurrent malignancies that interfere with the planned study treatment or the prognosis of resected LRRC.

Study & Design

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