Clinical trial · Interventional
Pencil Beam Proton Therapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy
NCT04695782CI-TRIAL-00049246ReRad IIrecruitingPhase 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)
Study design: A prospective phase II, non-randomized observational study of dose-escalated pencil beam proton therapy re-irradiation for pelvic recurrences from rectal cancer. Re-irradiation is either a part of neo-adjuvant treatment or as a definitive treatment strategy for un-resectable recurrences.
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 Recurrent | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pencil beam proton radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Neo-adjuvant pencil beam proton therapy: 55 Gy(RBE)/44fx (1.25 Gy per fraction), two daily
- interventionNames
- Radiation: Pencil beam proton radiotherapy
- type
- EXPERIMENTAL
- label
- Definitive arm pencil beam proton therapy: 57.5-65Gy(RBE)/46-52 fx (1.25 per fraction) two daily
- interventionNames
- Radiation: Pencil beam proton radiotherapy
Primary outcomes (2)
- measure
- R0-resection
- timeFrame
- 5-6 years
- description
- Neo-adjuvant treatment: Rate of pathological complete resection (R0)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * • Locally recurrent rectal cancer. * Bioptically verified (adenocarcinoma ) * Available dose plan from primary radiotherapy * Previous pelvic RT (\>30Gy EQD2) * Evaluated in MDT-conferences (Herlev, Aarhus) * Age\>18 years * PS 0-2 * Adequate organ function * Informed consent Exclusion Criteria: * Non-resectable distant metastases (PET-CT) * Unable to undergo MRI, PET-CT * Inability to attend full course radiotherapy and follow up in the out patient clinic.
References
Publications (0)
Data not yet available
No reference posted for this study.