Combining chemotherapy with radiation therapy for inoperable lung cancer
Pilot Study of the Safety and Feasibility of Administering Concurrent Chemotherapy and Accelerated Hypofractionated Radiation Therapy in the Treatment of Medically Inoperable T2A-T4 N0 Non-small Cell Lung Cancer.
This study is testing if combining chemotherapy with focused radiation can help people with inoperable lung cancer feel better and have fewer side effects.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | State University of New York - Upstate Medical University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Syracuse, New York) |
| Trial ID | NCT02619448 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of combining chemotherapy with hypofractionated radiation therapy in patients with inoperable non-small cell lung cancer (NSCLC). The trial aims to enroll twelve participants who have a solitary lung lesion and cannot undergo surgery due to medical reasons. The treatment regimen includes carboplatin and paclitaxel alongside radiation therapy delivered in a focused manner to minimize damage to surrounding tissues. The primary goal is to assess side effects and determine if this approach can provide a viable alternative to surgery for these patients.
Who should consider this trial
Good fit: Ideal candidates are patients with pathologically confirmed NSCLC who have a solitary lesion measuring 2-7 cm and are medically inoperable.
Not a fit: Patients with node-positive or metastatic disease, or those with other active malignancies, are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new option for patients with inoperable lung cancer, potentially improving survival rates and quality of life.
How similar studies have performed: While there is existing research on radiation therapy for lung cancer, this specific combination of chemotherapy and hypofractionated radiation therapy is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pathologically or cytologically proven diagnosis of non-small cell lung carcinoma. * Solitary \[T1bN0M0, T2aN0M0, T2bN0M0\] lesion measuring 2-7cm in size. Staging is per AJCC 7th edition of TNM classification. * Patient must meet criteria for receipt of hypofractionated radiation therapy * Medically inoperable pulmonary status, cardiac status, or other serious co-morbidity, or patient refusal of primary surgery for lung cancer. * ECOG Performance status of 0-2. * Patients may have prior treatment for lung cancer based on the following criteria: 1. Surgical resection is allowed if surgery was \> 12 months ago. 2. Patients treated with prior radiation are eligible if radiation was \> 12 months ago and there is no evidence of progression and if the lesion is in a different lobe. 3. Prior chemotherapy if \> 18 months ago Exclusion Criteria: * Node positive or metastatic disease. * Other active malignancy (specifically, risk of recurrence in 3 years estimated to be greater than 50%) except for non-melanoma skin cancer, in-situ cervical carcinoma (CIN), or low-risk prostate carcinoma on active surveillance are to be excluded. * Inability to receive systemic therapy or radiation therapy per protocol. * Inability to fulfill requirements of the protocol. * Any co-morbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol.
Where this trial is running
Syracuse, New York
- SUNY Upstate Medical University — Syracuse, New York, United States (Recruiting)
Study contacts
- Principal investigator: Michael Mix, MD — State University of New York - Upstate Medical University
- Study coordinator: Erin Bingham, BS
- Email: binghame@upstate.edu
- Phone: 3154643603
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.