Status:
RECRUITING
Induction Chemotherapy for Locally Recurrent Rectal Cancer
Lead Sponsor:
Catharina Ziekenhuis Eindhoven
Conditions:
Recurrent Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 neo...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Radiological evidence of metastatic disease (e.g. liver, lung) at time of randomisation or in the six months prior to randomisation.
- Known homozygous DPD deficiency
- Any chemotherapy in the past 6 months.
- Any contraindication for the planned chemotherapy, as determined by the medical oncologist.
- Radiotherapy in the past 6 months for primary rectal cancer.
- Any contraindication for the planned chemoradiotherapy, 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.
Key Trial Info
Start Date :
November 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2030
Estimated Enrollment :
364 Patients enrolled
Trial Details
Trial ID
NCT04389086
Start Date
November 13 2020
End Date
March 1 2030
Last Update
September 6 2022
Active Locations (14)
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1
UZ Gent
Ghent, Belgium
2
Amsterdam UMC
Amsterdam, Netherlands
3
Antoni van Leeuwenhoek
Amsterdam, Netherlands
4
Catharina Hospital
Eindhoven, Netherlands, 5623EJ