Induction chemotherapy for recurrent rectal cancer
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
This study is testing if adding induction chemotherapy before standard treatment can help people with locally recurrent rectal cancer have better surgery results.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 364 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Catharina Ziekenhuis Eindhoven Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 14 sites (Ghent and 13 other locations) |
| Trial ID | NCT04389086 on ClinicalTrials.gov |
What this trial studies
This multicenter, open-label, phase III study aims to evaluate the effectiveness of induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery in patients with locally recurrent rectal cancer. Participants will be randomly assigned in a 1:1 ratio to either the experimental arm receiving induction chemotherapy or the control arm receiving standard neoadjuvant chemoradiotherapy and surgery. The study seeks to determine if the addition of induction chemotherapy improves surgical outcomes and resection margins. The trial will involve multiple locations and will assess patient responses through imaging and clinical evaluations.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed locally recurrent rectal cancer that is deemed resectable.
Not a fit: Patients with evidence of metastatic disease or those who have had recent chemotherapy or radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and increase the chances of complete resection in patients with recurrent rectal cancer.
How similar studies have performed: Other studies have explored similar neoadjuvant approaches, showing promising results, but this specific combination is being tested for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Ghent and 13 other locations
- UZ Gent — Ghent, Belgium (Not_yet_recruiting)
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
- Antoni van Leeuwenhoek — Amsterdam, Netherlands (Recruiting)
- Catharina Hospital — Eindhoven, Netherlands (Recruiting)
- University Medical Centre Groningen — Groningen, Netherlands (Recruiting)
- Leids University Medical Centre — Leiden, Netherlands (Recruiting)
- Haaglanden Medical Centre — Leidschendam, Netherlands (Recruiting)
- Maastricht University Medical Centre — Maastricht, Netherlands (Recruiting)
- Erasmus Medical Centre — Rotterdam, Netherlands (Recruiting)
- Oslo Universitetssykehus — Oslo, Norway (Not_yet_recruiting)
- Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. — Lisbon, Portugal (Not_yet_recruiting)
- Sahlgrenska Universitetssjukhuset — Gothenburg, Sweden (Not_yet_recruiting)
- Skåne Universitetssjukhuset — Malmö, Sweden (Not_yet_recruiting)
- Karolinska Universitetssjukhuset — Stockholm, Sweden (Not_yet_recruiting)
Study contacts
- Principal investigator: Pim Burger, MD — Catharina Ziekenhuis Eindhoven
- Study coordinator: Stefi Nordkamp, MD
- Email: stefi.nordkamp@catharinaziekenhuis.nl
- Phone: 0031 40 2398858
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.