Clinical trial · Interventional
Concurrent Chemo-proton Radiotherapy With or Without Resection and Spacer Insertion for Loco-regional Recurrence of Previous Irradiated Rectal Cancer
Concurrent Chemo-proton Radiotherapy With or Without Resection and Spacer Insertion for Loco-regional Recurrence of Previous Irradiated Rectal Cancer: Prospective Phase II Trial
NCT03098108CI-TRIAL-00033496RECCPTunknownN/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 investigators conduct this study to evaluate the efficacy and adverse effect of salvage concurrent chemo-proton therapy (CCPT) with or without surgical resection in previously irradiated recurrent rectal cancer.
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 |
|---|---|---|---|
| Previously Irradiated Recurrent Rectal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Concurrent chemo-proton therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CCPT
- interventionNames
- Radiation: Concurrent chemo-proton therapy
Primary outcomes (1)
- measure
- local control rate at 3-year
- timeFrame
- 3-year after CCPT
- description
- Local progression will be defined according to the revised Response Evaluation Criteria in Solid Tumor (RECIST version 1.1)
Secondary outcomes (6)
- measure
- adverse events
- timeFrame
- 3 months after CCPT
- description
- Adverse events will be evaluated with the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * previously diagnosed as rectal cancer and received curative intent treatment * diagnosed as recurrent rectal cancer either pathology or radiologic exam * discussed at tumor board and recommend proton therapy * previous history of pelvic area radiotherapy * Eastern Cooperative Oncology Group performance status of 0 to 2 * informed consent to present study * consent to contraception for 6 months during and after study participation * maintained bone marrow function ( absolute neutrophil count ≥ 1,2 \* 109/L, platelet count ≥ 100 \* 109/L) * maintained renal, hepatic function creatinine clearance ≥ 50 mL/minute total bilirubin ≥ 2.2 mg/dl alkaline phosphatase ≥ 192 U/L Exclusion Criteria: * Pregnant and/or breastfeeding woman * Less than 12 weeks of expected survival * Uncontrolled active co-morbidity
References
Publications (0)
Data not yet available
No reference posted for this study.