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
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug, Radiation, Procedure
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This is a multicentre, open-label, parallel arms, phase IIII study that randomises patients with locally recurrent rectal cancer in a 1:1 ratio to receive either induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery (experimental arm) or neoadjuvant chemoradiotherapy and surgery alone (control arm)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 18 years or older
• Confirmed locally recurrent rectal cancer after total or partial mesorectal resection for rectal 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
Locations
Other Locations
Belgium
UZ Gent
NOT_YET_RECRUITING
Ghent
Netherlands
Amsterdam UMC
RECRUITING
Amsterdam
Antoni van Leeuwenhoek
RECRUITING
Amsterdam
Catharina Hospital
RECRUITING
Eindhoven
University Medical Centre Groningen
RECRUITING
Groningen
Leids University Medical Centre
RECRUITING
Leiden
Haaglanden Medical Centre
RECRUITING
Leidschendam
Maastricht University Medical Centre
RECRUITING
Maastricht
Erasmus Medical Centre
RECRUITING
Rotterdam
Norway
Oslo Universitetssykehus
NOT_YET_RECRUITING
Oslo
Portugal
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.
NOT_YET_RECRUITING
Lisbon
Sweden
Sahlgrenska Universitetssjukhuset
NOT_YET_RECRUITING
Gothenburg
Skåne Universitetssjukhuset
NOT_YET_RECRUITING
Malmo
Karolinska Universitetssjukhuset
NOT_YET_RECRUITING
Stockholm
Contact Information
Primary
Stefi Nordkamp, MD
stefi.nordkamp@catharinaziekenhuis.nl
0031 40 2398858
Backup
Floor Piqeur, MD
floor.piqeur@catharinaziekenhuis.nl
0031 40 2397152
Time Frame
Start Date:2020-11-13
Estimated Completion Date:2030-03-01
Participants
Target number of participants:364
Treatments
Experimental: Induction chemotherapy + chemoradiotherapy + surgery
Induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery
Active_comparator: Neoadjuvant chemotherapy + surgery