Clinical trial · Interventional
Re-irradiation for Pelvic Recurrences in Rectal Cancer Patients
External Beam Radiotherapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy
NCT05816980CI-TRIAL-00065692Re-RAD-IcompletedPhase 2ClinicalTrials.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)
This study investigates the potential benefit of re-irradiation of patients with locally advanced rectal recurrences, by a prospective phase II clinical, imaging and translational research study.
Conditions
Conditions (3)
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 Toxicity | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Recurrence | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperfractionated external beam radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single
- description
- Re-irradiation consisting of hyperfractionated IMRT, 40.8 Gy in 1.2 fractions twice daily 5/7 days weekly, with oral capecitabine 825 mg/m2 BID on radiotherapy treatment days. Re-staging performed 4-6 weeks after the last dose, followed by surgery, when feasible.
- interventionNames
- Radiation: Hyperfractionated external beam radiation
Primary outcomes (1)
- measure
- Resection rate
- timeFrame
- At surgery
- description
- Rate of complete pathological resection R0
Secondary outcomes (5)
- measure
- Physician reported Toxicity
- timeFrame
- Acute and late toxicity evaluations during and at 6,12 and 36 months post surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Locally recurrent rectal cancer * Previous pelvic RT for rectal cancer and surgery * Potentially resectable by MRI and palpation by MDT evaluation * Absence of non-resectable distant metastases by PET-CT * Age ≥ 18 * Adequate organ function * Acceptable bowel and bladder function * Acceptance for TR sampling Exclusion Criteria: * Central small recurrences deemed immediate resectable * Previous radiotherapy \<12 month prior to recurrence * Non-resectable systemic or regional disease * Unable to undergo MRI or PET-CT * Medical comorbidities precluding radical surgery
References
Publications (0)
Data not yet available
No reference posted for this study.