A Phase I/II Study of Hypofractionated Proton Therapy for Stage II-III Non-Small Cell Lung Cancer (NCT01770418) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Phase I/II Study of Hypofractionated Proton Therapy for Stage II-III Non-Small Cell Lung Cancer
United States32 participantsStarted 2013-03
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 dis…
What they're measuring
1
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
2
Phase II: Determine the percentage of patients that survive at least 12 months