Clinical trial · Interventional
Higher Radiation Dose to the Tumor May Help Avoid Surgery in Rectal Cancer Patients
REctal Organ Preservation With a BOost Approach Using CBCT-based Online Adaptive radioTherapy
NCT07616297CI-TRIAL-00113106REBOOTrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 goal of this prospective study is to evaluate if a higher radiation dose to the tumor can increase the organ preservation rate in non-locally advanced rectal cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiation Oncology | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Simultaneous integrated boost to the tumor and positive mesorectal lymph nodes | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Simultaneous integrated boost
- description
- Treatment arm, in which all participating patients will receive the simultaneous integrated boost (SIB)
- interventionNames
- Radiation: Simultaneous integrated boost to the tumor and positive mesorectal lymph nodes
Primary outcomes (1)
- measure
- Organ preservation
- timeFrame
- During two-year follow-up
- description
- Organ preservation is considered unsuccessful if the rectum is surgically removed, a stoma is present, or a non-salvageable locoregional cancer recurrence is developed.
Secondary outcomes (13)
- measure
- Rate of clinical complete response
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years * Eastern cooperative oncology group (ECOG) performance status ≤2 * Histologically confirmed rectal adenocarcinoma * Non-locally advanced rectal cancer, defined as (magnetic resonance imaging (MRI)-based) T1-3, N0/N1 (≤3 positive mesorectal lymph nodes), MX/M0 * Indication for curative treatment with organ preservation * Discussed in the multidisciplinary tumor board (MTB) * Written informed consent Exclusion Criteria: * Previous radiotherapy in the pelvic area * Other malignancies, except for adequately treated basal cell carcinoma (BCC), at time of inclusion or within 3 years prior to inclusion * Contra-indications for (chemo)radiotherapy or surgery * Presence of lateral lymph nodes, cN2 status, extramural vascular invasion (EMVI) or mesorectal fascia involvement as seen on MRI * Mucinous defined tumor on MRI * Prior local excision of the primary tumor * DPD (dihydropyrimidine dehydrogenase) deficiency * Unable to understand the requirements of the study and to give written informed consent, as determined by the treating physician
References
Publications (0)
Data not yet available
No reference posted for this study.