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Induction Chemotherapy for Locally Recurrent Rectal Cancer
Sponsor: Catharina Ziekenhuis Eindhoven
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)
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
364
Start Date
2020-11-13
Completion Date
2030-03-01
Last Updated
2022-09-06
Healthy Volunteers
No
Conditions
Interventions
Combination drug
Induction chemotherapy consists of either three three-weekly cycles of CAPOX (oxaliplatin 130 mg/m2 BSA IV + capecitabine 1000 mg/m2 BSA, orally, twice daily) or four two-weekly cycles of FOLFOX (85 mg/m2 BSA of oxaliplatin IV + 400 mg/m2 BSA of leucovorin IV + 400 mg/m2 BSA of bolus 5-fluorouracil IV followed by 2400 mg/m2 BSA of continuous 5-fluorouracil IV). It is left to the discretion of the treating medical oncologist which of the two will be administered. In case of (previous) unacceptable toxicity (physician's discretion) to oxaliplatin, FOLFIRI may be prescribed. FOLFIRI (180 mg/m2 BSA of irinotecan IV + 400 mg/m2 BSA of leucovorin IV + 400 mg/m2 BSA of bolus 5-fluorouracil IV followed by 2400 mg/m2 BSA of continuous 5-fluorouracil IV) consists of four two-weekly cycles. If a patient has stable or responsive disease, induction chemotherapy will be continued with either one three-weekly cycle of CAPOX or two two-weekly cycles of FOLFOX/FOLFIRI.
Chemoradiotherapy
Concomitant chemotherapy agent: capecitabine Radiotherapy dose: full course radiotherapy consists of 25x2.0 or 28x1.8 Gy. In case of previous radiotherapy, the radiotherapy dose will consist of 15x2.0 Gy.
Surgery locally recurrent rectal cancer
Type of surgery depends on the location of the recurrence and involvement of adjacent structures and is left to the discretion of the operating surgeon. Intraoperative radiotherapy is optional.
Locations (14)
UZ Gent
Ghent, Belgium
Amsterdam UMC
Amsterdam, Netherlands
Antoni van Leeuwenhoek
Amsterdam, Netherlands
Catharina Hospital
Eindhoven, Netherlands
University Medical Centre Groningen
Groningen, Netherlands
Leids University Medical Centre
Leiden, Netherlands
Haaglanden Medical Centre
Leidschendam, Netherlands
Maastricht University Medical Centre
Maastricht, Netherlands
Erasmus Medical Centre
Rotterdam, Netherlands
Oslo Universitetssykehus
Oslo, Norway
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.
Lisbon, Portugal
Sahlgrenska Universitetssjukhuset
Gothenburg, Sweden
Skåne Universitetssjukhuset
Malmo, Sweden
Karolinska Universitetssjukhuset
Stockholm, Sweden