Clinical trial · Interventional
Study of Hypofractionated Proton Radiation Therapy in Thoracic Malignancies
Phase I Study of Hypofractionated Proton Radiation Therapy in Thoracic Malignancies
NCT01165658CI-TRIAL-00042528terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Requested by PI during yearly Continuing Review
Summary
Brief summary (as posted)
The goal of this clinical research study is to study the safety of giving larger daily doses of proton radiation therapy than the standard dose levels given to treat lung cancer. Researchers want to find the highest daily dose of proton radiation that can be given without having to stop therapy due to side effects.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoid | Neuroendocrine Tumor | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
| Thymic Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Proton Therapy
- description
- The radiation prescription dose ranges from 45 Gy in 3 Gy fractions to 60 Gy in 4 Gy fractions. Patients will be assigned to receive 1 of 3 doses of radiation therapy, based on when they joined the study. The first group of at least 3 participants will receive the lowest total radiation dose. If the first dose is tolerated well by the first group of participants in this study, then the next group of participants will receive the second, higher dose of radiation. If this dose is tolerated, then a third group will be treated at the highest dose.
- interventionNames
- Radiation: Proton Therapy
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD) of Hypofractionated Proton Therapy
- timeFrame
- 1 month after completion of radiation therapy
- description
- Dose-limiting toxicity (DLT) defined as any CTCAE v4.0 grade 4 complication of esophagus or skin, or any grade 3 or higher complications of other organ systems (i.e. lung, liver, kidney, or GI tract), unless these complications are deemed to be related to those of esophagus. DLT assessed within 1 month of completion of radiation therapy. MTD defined as highest dose for which probability of toxicity is closest to 25%.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically documented NSCLC, SCLC, thymic tumors, or carcinoid tumors 2. Patients not receiving concurrent chemotherapy 3. Patients that are eligible for concurrent treatment with biologic agents (epidermal growth factor receptor \[EGFR\] or vascular endothelial growth factor \[VEGF\] inhibitors) will be eligible for the study. Exclusion Criteria: 1. Prior radiotherapy to the chest 2. Life expectancy \<6 months 3. Pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.