NCT04389086RecruitingPhase 3
Induction Chemotherapy for Locally 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
Source: ClinicalTrials.gov · Last updated 6 Sept 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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)
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 364 (estimated)
- First submitted
- 7 May 2020
- Start date
- 13 Nov 2020
- Primary completion date
- 1 Mar 2024
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Diseases
- Colorectal cancer
- NCT number
- NCT04389086
- EU CT number
- 2024-512526-28-00
- EudraCT number
- 2020-002141-42
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 364
- From 13 Nov 2020 to the primary completion date, 1 Mar 2024
- 33 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Radiological evidence of metastatic disease (e.g. liver, lung) at time of randomisation or in the six months prior to randomisation.
- Any chemotherapy in the past 6 months.
- Any contraindication for the planned chemotherapy, as determined by the medical oncologist.
- 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.
Other illness
- Radiotherapy in the past 6 months for primary rectal cancer.
Other
- Known homozygous DPD deficiency
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (33)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| Noordwest Ziekenhuisgroep Stichting Coordinator of this site? Confirm its status | Alkmaar | Netherlands | Recruiting |
| Academic Medical Center at the University of Amsterdam Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Gelre Hospitals Coordinator of this site? Confirm its status | Apeldoorn | Netherlands | Recruiting |
| Rijnstate Ziekenhuis Stichting Coordinator of this site? Confirm its status | Arnhem | Netherlands | Recruiting |
| Radiotherapiegroep Coordinator of this site? Confirm its status | Arnhem | Netherlands | Recruiting |
| Amphia Hospital Coordinator of this site? Confirm its status | Breda | Netherlands | Recruiting |
| Catharina Ziekenhuis Stichting Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Recruiting |
| Medisch Spectrum Twente Coordinator of this site? Confirm its status | Enschede | Netherlands | Recruiting |
| Admiraal De Ruyter Ziekenhuis B.V. Coordinator of this site? Confirm its status | Goes | Netherlands | Recruiting |
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
| Medisch Centrum Leeuwarden B.V. Coordinator of this site? Confirm its status | Leeuwarden | Netherlands | Recruiting |
| Radiotherapeutisch Instituut Friesland Coordinator of this site? Confirm its status | Leeuwarden | Netherlands | Recruiting |
| Leids Universitair Medisch Centrum (LUMC) Coordinator of this site? Confirm its status | Leiden | Netherlands | Recruiting |
| Medical Center Haaglanden Coordinator of this site? Confirm its status | Leidschendam | Netherlands | Recruiting |
| Maastro Clinic Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
| University Hospital Maastricht Coordinator of this site? Confirm its status | Maastricht | Netherlands | Recruiting |
| Sint Antonius Ziekenhuis Stichting Coordinator of this site? Confirm its status | Nieuwegein | Netherlands | Recruiting |
| Radboud Universitair Medisch Centrum (Radboudumc) Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
| Bravis Ziekenhuis Coordinator of this site? Confirm its status | Roosendaal | Netherlands | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Jeroen Bosch Ziekenhuis Coordinator of this site? Confirm its status | 's-Hertogenbosch | Netherlands | Recruiting |
| Dr. Bernard Verbeeten Instituut Stichting Coordinator of this site? Confirm its status | Tilburg | Netherlands | Recruiting |
| Elisabeth-Tweesteden Ziekenhuis Coordinator of this site? Confirm its status | Tilburg | Netherlands | Recruiting |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
| Zuidwest Radiotherapeutisch Instituut Coordinator of this site? Confirm its status | Vlissingen | Netherlands | Recruiting |
| Isala Klinieken Stichting Coordinator of this site? Confirm its status | Zwolle | Netherlands | Recruiting |
| Oslo University Hospital HF Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Sahlgrenska University Hospital-Vaestra Goetalandsregionen Coordinator of this site? Confirm its status | Goteborg | Sweden | Recruiting |
| Region Skane Skanes Universitetssjukhus Coordinator of this site? Confirm its status | Lund | Sweden | Recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Stockholm | Sweden | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.