Induction Chemotherapy for Locally Recurrent Rectal Cancer
Recruiting · NCT04389086 · Interventional (participants receive a specific treatment) · Lead sponsor: Catharina Ziekenhuis Eindhoven
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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)
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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 it is running
14 locations listed.
- Amsterdam UMC - Amsterdam, Netherlands
- Antoni van Leeuwenhoek - Amsterdam, Netherlands
- Catharina Hospital - Eindhoven, Netherlands
- UZ Gent - Ghent, Belgium
- Sahlgrenska Universitetssjukhuset - Gothenburg, Sweden
- University Medical Centre Groningen - Groningen, Netherlands
- Leids University Medical Centre - Leiden, Netherlands
- Haaglanden Medical Centre - Leidschendam, Netherlands
- Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. - Lisbon, Portugal
- Maastricht University Medical Centre - Maastricht, Netherlands
- Skåne Universitetssjukhuset - Malmö, Sweden
- Oslo Universitetssykehus - Oslo, Norway
- Erasmus Medical Centre - Rotterdam, Netherlands
- Karolinska Universitetssjukhuset - Stockholm, Sweden