Addition of induction chemotherapy to the neoadjuvant treatment of patients with locally recurrent rectal cancer - the PelvEx II study

Phase 1

• Conditions: ocally recurrent rectal cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-002141-42-NL
• Lead Sponsor: Catharina Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-29
• Last Update Posted: 12 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 364

Inclusion Criteria

• 18 years or older
• Confirmed local recurrent rectal cancer after total or partial mesorectal resection for rectal 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
• WHO performance score 0-1
• 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 182
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 182

Exclusion Criteria

• Radiological evidence of systemic metastatic disease (e.g. liver, lung) at time of randomisation or in the six months prior to randomisation
• Homozygous DPD deficiency
• Any chemotherapy in the past 6 months
• Any contraindication for the planned chemotherapy (e.g. severe allergy, pregnancy, kidney dysfunction with creatinine clearance of <30ml/min, thrombocytopenia of <100x109/L), as determined by the medical oncologist
• Radiotherapy in the past 6 months for primary rectal cancer
• 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