Clinical trial · Interventional
A Phase I/II Study of Hypofractionated Proton Therapy for Stage II-III Non-Small Cell Lung Cancer
NCT01770418CI-TRIAL-00094806active not recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
The purpose of this research study is to compare the effects (good and bad) on subjects and their cancer using standard chemotherapy in combination with hypofractionated proton radiation therapy. Hypofractionation is a technique that delivers higher daily doses of radiation over a shorter period of time.
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 |
|---|---|---|---|
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation with Concurrent Chemotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Proton Radiotherapy with Chemotherapy
- interventionNames
- Radiation: Radiation with Concurrent Chemotherapy
Primary outcomes (2)
- measure
- Phase I: Establish the maximum tolerated dose of radiotherapy in terms of Gy (RBE)/fraction using hypofractionated proton therapy concurrently with chemotherapy.
- timeFrame
- Weekly until completion of radiation treatment
- description
- This phase will have a minimum of 2 treated patients and we anticipate that the MTD will be located before a maximum of 28 patients are treated. The trial begins by treating 5 patients at 2.5 Gy (RBE)/fraction to a dose of 60 Gy (RBE).
- measure
- Phase II: Determine the percentage of patients that survive at least 12 months
- timeFrame
- At 12 months
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed invasive non-small cell lung cancer within 12 weeks prior to study registration. OR Pathologically confirmed invasive non-small cell lung cancer within 6 months prior to study registration if the patient received induction chemotherapy. * AJCC (American Joint Committee on Cancer) 7th Ed. clinical stage II-III. * ECOG Performance status 0-1 within 8 weeks prior to study registration. * Patient must give study-specific informed consent on an IRB-approved consent prior to any research-related procedures or study treatment. * Patient must be at least 18 years old at the time of consent. * Patient must complete all required tests in section 4. * Lab results per the following within 4 weeks prior to study registration: * Absolute neutrophil count (ANC) \>1,800 cells/mm3. * Platelets \> = 100,000 cells/mm3. * Hemoglobin \> =10 g/dl. The use of transfusion or other intervention to achieve Hgb ≥10.0 g/dl is acceptable. * AST/SGOT and ALT/SGPT \< 2.5 x the institutional upper limit of normal (IULN). * Post exploratory thoracotomy must be done \> 3 weeks prior to study registration or patient did not have post exploratory thoracotomy. * PFT (pulmonary function test) with a FEV1 \> 0.75 liters/second within 16 weeks prior to study registration. * Patients must be evaluated by a thoracic surgeon, pulmonologist or medical oncologist and deemed medically or surgically unacceptable for resection. Exclusion Criteria: * Evidence of distant metastasis (M1) involvement. * Prior radiotherapy to thoracic area. * Unintentional weight loss \>10% within 4 weeks prior to study registration. * Pregnant and/or breast-feeding women, or patients (men and women) of child-producing potential not willing to use medically acceptable forms of contraception while on study treatment and for at least 12 months after study treatment. Pregnancy testing is not necessary for women who have had a hysterectomy or have not had a menstrual period for at least 24 consecutive months.
References
Publications (0)
Data not yet available
No reference posted for this study.