Clinical trial · Interventional
Simultaneous Integrated Boost Preoperative Radiotherapy for Rectum Cancer
Randomized Trial of Preoperative Radiotherapy With an Integrated Simultaneous Boost Compared to Chemoradiotherapy for T3-4 Rectal Cancer
- 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)
The investigators propose a randomized non-inferiority trial that compares preoperative Fluoro Uracil (FU)-based chemoradiotherapy to radiotherapy with a simultaneous integrated boost. In patients with T3-4 rectal cancer, the latter approach is considered preferential with regard to toxicity and cost. The metabolic response of the tumor, as assessed by 18F-2-Fluoro-2-Deoxyglucose-Positron Emission tomography (18F-FDG PET) or PET-CT, will be used as a surrogate marker of cause specific outcome
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 |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemoradiotherapy | Other | — | UNRESOLVED |
| Radiotherapy with boost | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Concomitant chemoradiotherapy
- description
- Radiotherapy (23 x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily, excluding weekends
- interventionNames
- Other: Chemoradiotherapy
- type
- EXPERIMENTAL
- label
- Radiotherapy with boost
- description
- Radiotherapy (23 x 2 Gy), with a simultaneous integrated boost up to 55.2 Gy on the primary tumor
- interventionNames
- Radiation: Radiotherapy with boost
Primary outcomes (1)
- measure
- reduction in metabolic tumor activity
- timeFrame
- at baseline and at 5 to 6 weeks after neo-adjuvant therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 95 Years
Show eligibility criteria text
Inclusion Criteria: * histopathologically confirmed rectal adenocarcinoma with an inferior border within 15 cm of the anal verge * the tumor has to have evidence of T3 or T4 disease on Magnetic Resonance Imaging (MRI) or endoluminal ultrasound Exclusion Criteria: * unresectable metastatic disease * Eastern Cooperative Oncology Group (ECOG) performance status \> 3 * patients not deemed fit for radiotherapy, capecitabine or surgery * pregnant or lactating patients * women with child bearing potential who lack effective contraception * patients below 18 years old
References
Publications (0)
Data not yet available