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

Phase 3

Recruiting

• Conditions: Locally recurrent rectal cancer; rectal cancer which returned locally; 10017991; 10017998

• Registration Number: NL-OMON54232
• Lead Sponsor: Catharina-ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 250

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
• WHO performance score 0-1
• Written informed consent

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 (if known in advance)
• Any chemotherapy in the past 6 months
• Any contraindication for the planned chemotherapy chemotherapy (e.g. severe
allergy, pregnancy, kidney dysfunction, thrombocytopenia), 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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To compare the proportion of resections with clear resection margins between<br /><br>both arms. </p><br>