Comparing Photon Therapy To Proton Therapy To Treat Patients With Lung Cancer (NCT01993810) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Comparing Photon Therapy To Proton Therapy To Treat Patients With Lung Cancer
United States330 participantsStarted 2014-02-03
Plain-language summary
This randomized phase III trial studies proton chemoradiotherapy to see how well it works compared to photon chemoradiotherapy in treating patients with stage II-IIIB non-small cell lung cancer that cannot be removed by surgery. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor, such as photon or proton beam radiation therapy, may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as paclitaxel, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether proton chemoradiotherapy is more effective than photon chemoradiotherapy in treating non-small cell lung cancer.
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:
* Histologically or cytologically proven diagnosis of non-small cell lung cancer
* Clinical American Joint Committee on Cancer (AJCC) (AJCC, 7th ed.) II, IIIA or IIIB (with non-operable disease; non-operable disease will be determined by a multi-disciplinary treatment team within 60 days prior to registration; note: for patients who are clearly nonresectable, the case can be determined by the treating radiation oncologist and/or a medical oncologist or pulmonologist
* Patients who present with N2 or N3 disease and an undetectable NSCLC primary tumor are eligible
* Patients who refuse surgery are eligible
* Patients who develop local recurrence after surgery and rendered candidate for definitive concurrent chemoradiation are also eligible
* Patients who have received systemic treatment (up to 4 cycles of induction chemotherapy, or up to 6 months of targeted therapy) are eligible
* Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:
* History/physical examination within 30 days prior to registration including resting heart rate;
* Fludeoxyglucose F 18 (FDG)-positron emission tomography (PET)/computed tomography (CT) scan for staging within 60 days prior to registration
* Magnetic resonance imaging (MRI) scan with contrast of the brain (preferred) or CT scan of the brain with contrast within 60 days prior to registration;
* Forced expiratory volume in one second (FEV1) \…
What they're measuring
1
Overall Survival
Timeframe: From registration until death or last follow-up; analysis occurs after 390 deaths have been reported