Cancer types
  • Digestive tract
Title of study
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.
Version Number
Approval Date 
3, 25 June 2020
Short Title
PelvEx II
Study site
Principle Investigator
Project leader: J.W.A. Burger, MD, PhD Department of Surgery Catharina Hospital, Eindhoven, the Netherlands Coordinating investigator E.L.K. Voogt, MD Department of Surgery Catharina Hospital, Eindhoven, the Netherlands
Investigator Maastro
Dr M. Berbée
Sponsor
Catharina Hospital Eindhoven, the Netherlands
Trial registry
Objectives 

The primary objective of this study is to determine the rate of resections with clear resection margins after treatment with induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery compared to treatment with neoadjuvant chemoradiotherapy and surgery alone.

Primary Endpoint 

The primary endpoint of the study is the rate of clear resection margins after surgery.

Secondary Endpoints 
  • Local re-recurrence free survival
  • Progression free survival
  • Distant metastasis free survival
  • Disease free survival, overall survival
  • Pathologic response
  • Radiological response
  • Systemic therapy related toxicity (NCI-CTCAE v5.0 grade ≥3)
  • The number of patients completing neoadjuvant treatment
  • Surgical characteristics
  • Major postoperative complications (Clavien-Dindo ≥3) up to 90-days postoperatively
  • Quality of life and cost-effectiveness.
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