Clinical trial · Interventional
Prospective Evaluation of Pencil Beam Scanning Proton Therapy for Previously Irradiated Tumors
- 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 clinical research trial is to study the use of differing investigational doses and scheduling for Proton Therapy for tumors previously treated with radiation therapy. Generally, when patients are first treated for cancer with radiation therapy, they are treated with traditional photon (or x-ray) radiation therapy, which uses high-energy waves to kill tumor cells. In some cases, the cancer either returns or a new tumor can present in a different part of the body. With the usual radiation treatment, the photon beams travel all the way through the body. As a result, healthy tissues in front of and behind the tumor are exposed to radiation. Physicians who treat these cases where the tumor has returned often use a much lower dose of radiation to prevent patients from experiencing serious and long-term side-effects. This dose is often not strong enough to destroy the cancerous tumor. Alternatively, they may also treat a smaller area than would be indicated for complete tumor eradication, again in an attempt to prevent serious and long-term toxicities, but at the cost of optimally treating the cancer. Proton therapy, however, may offer a chance to safely deliver a more effective dose and volume of radiation as it is more targeted and can spare healthy tissues surrounding the tumor. The reason we are conducting this research study is to look at whether Proton therapy can be a better way to treat reoccurring tumors in patients who have previously received radiation therapy to the same area, compared to treatment approaches used to date.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| CNS Cancer | Malignant Central Nervous System Neoplasm | ALIAS | 0.90 |
| GI Cancer | — | UNRESOLVED | — |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Thoracic Cancer | Malignant Thoracic Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pencil Beam Scanning Proton Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- Cohort 1: Central Nervous System
- description
- Group 1 Definitive Reirradiation Phase II * Patients w/history of intracranial or spinal (extradural, intradural, and/or intramedullary) CNS tumors for which radiation therapy was prev. delivered either to gross disease or in the postoperative setting * Min. 6 month interval b/w RT courses * Overlap of prior RT field (50% IDL) * Subgroup analysis: receipt of surgery for recurrence/second IC tumor; concurrent ST; tumor histology Group 2 CNS Reirradiation Registry * Patients for whom a repeat course of RT to the CNS is indicated for recurrent disease or secondary primary * Postop or intact setting * Min. 6 month interval b/w RT courses * Overlap of prior RT field (50% IDL) * Histologically/clinically documented recurrent CNS tumor (benign or malignant) * Glioblastoma (histologic or molecular including IDH wildtype) * Astrocytoma (molecular IDH1 mutant) * Oligodendroglioma (molecular 1p19q co deleted) * Meningioma * Ependymoma * Chordoma/chondrosarcoma
- interventionNames
- Radiation: Pencil Beam Scanning Proton Therapy
- type
- EXPERIMENTAL
- label
- Cohort 2: Head/Neck
- description
- Group 1 Full Dose Reirradiation Phase II * Patients w/history of HNC for which RT was delivered definitively, now with recurrence to h/n amenable to full dose reRT * Gross unresected disease or PORT 2/2 RF * Received at least 40 Gy overlapping w/new target region * Min. 6 month interval b/w RT courses * Overlap of prior RT field (50% IDL) * Subgroup analysis: surgery, HPV status, concurrent ST Group 2 Early (\<6months for prior RT) Palliative H/N ReRT Phase I * Patients w/history of HNC for which RT was delivered definitively/adjuvant setting, now with biopsy proven recurrence to h/n with indication for palliative RT * At least 30 Gy prior RT overlapping with new treatment volume * \<6 month interval between RT courses Group 3 Head/Neck ReRT Registry * Patients w/history of HNC for which RT was delivered now with recurrence/secondary primary requiring reRT * Postop or definitive * Prior RT dose at least 30 Gy overlapping w/new treatment volume * Min.6 month interval b/w RT courses
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years * Patient provides study specific informed consent prior to study entry. * Documented history and physical exam within 90 days prior to registration. * ECOG PS 0, 1, or 2 within 90 days prior to registration Exclusion Criteria: * Non malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow up. * Prior invasive non study malignancy unless disease free for ≥ 3 years * Non melanoma skin cancer, low risk prostate cancer, well differentiated thyroid cancers, in situ carcinomas of the oral cavity, cervix, and other organs, and tumors that are not thought to impact the life expectancy of the patient are permissible. * History of active connective tissue disorder (i.e., systemic lupus erythematosus, scleroderma), dermatomyositis, xeroderma pigmentosum
References
Publications (0)
Data not yet available