Induction Chemotherapy for Locally Recurrent Rectal Cancer
About this study
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)
- Condition
- Recurrent Rectal Cancer
- Tested
- Combination drug, Chemoradiotherapy, Surgery locally recurrent rectal cancer
- Sponsor
- Catharina Ziekenhuis Eindhoven
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 7
- Minimum age: 18 years
- Study condition: Recurrent Rectal Cancer
- 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 8
- 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.
Where
14 sites, 14 recruiting
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
and 8 more sites on ClinicalTrials.gov
Contact
-
Stefi Nordkamp, MD
0031 40 2398858 stefi.nordkamp@catharinaziekenhuis.nl
-
Floor Piqeur, MD
0031 40 2397152 floor.piqeur@catharinaziekenhuis.nl
Potential match only. Final eligibility is determined by the study team.