Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Rectal Cancer | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemoradiotherapy | Radiation | — | UNRESOLVED |
| Combination drug | Drug | — | UNRESOLVED |
| Surgery locally recurrent rectal cancer | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Induction chemotherapy + chemoradiotherapy + surgery
- description
- Induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery
- interventionNames
- Drug: Combination drug
- Radiation: Chemoradiotherapy
- Procedure: Surgery locally recurrent rectal cancer
- type
- ACTIVE_COMPARATOR
- label
- Neoadjuvant chemotherapy + surgery
- description
- Neoadjuvant chemoradiotherapy followed by surgery
- interventionNames
- Radiation: Chemoradiotherapy
- Procedure: Surgery locally recurrent rectal cancer
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available