Chemotherapy before chemoradiotherapy and surgery for recurrent rectal cancer
Tests chemotherapy given before chemoradiotherapy and surgery in adults with returned rectal cancer.
Plain-language title generated from the registry record
Registry title: Induction Chemotherapy for Locally Recurrent Rectal Cancer
Key facts
- Where
- Oslo, NorwaySee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose rectal cancer has come back in the same area after surgery, and where the tumour can be removed by surgery.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Rectal cancer that has come back locally after earlier surgery (total or partial mesorectal resection for rectal or distal sigmoid cancer). It is confirmed by tissue test or by imaging plus clinical findings. The tumour can be removed by surgery on MRI, or is judged removable after chemoradiotherapy. WHO performance score 0-1.
- Earlier treatment
- Must have had earlier surgery for the rectal or distal sigmoid cancer. Cannot have had any chemotherapy in the past 6 months, or radiotherapy for the first rectal cancer in the past 6 months.
- Biomarker or test result
- Known homozygous DPD deficiency is an exclusion. No other marker is asked for.
Main reasons for not taking part
- Signs of cancer spread to other organs (for example liver, lung) now or in the past 6 months
- Known homozygous DPD deficiency
- Any chemotherapy in the past 6 months
- Radiotherapy for the first rectal cancer in the past 6 months
- Any reason the doctors say the planned chemotherapy, chemoradiotherapy or surgery cannot be given
Read by machine on 12 November 2026.
Where in Norway
- Oslo University Hospital HFOslo, NorwayTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Catharina Ziekenhuis Eindhoven
- Trial code
- NCT04389086EU 2024-512526-28-00
- Record updated
- 6 September 2022
- Original description
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)Read full original descriptionShow less
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 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)
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; 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; Radiotherapy in the past 6 months for primary rectal cancer; Known homozygous DPD deficiency.