Concurrent Chemotherapy Plus HFR Radiation Therapy in Inoperable NSCLC
The standard treatment for patients with Non-Small Cell Lung Cancer (NSCLC) and clinically negative lymph nodes remains surgery per current guidelines. Five year survival for patients with stage I non-small cell lung cancer is generally greater than 50% after surgery. Many of these patients have heart and lung issues or other diseases which keep them from undergoing curative surgery. Studies have shown that majority of these patients die from their cancer and not from their other diseases. This is the reason for treating early stage lung cancer patients with definitive therapy, when they cannot have surgery. This study will enroll twelve subjects to evaluate the side effects of this treatment, and decide if it is a good option for the patients that cannot have surgery.
Conditions:
🦠 Non-small Cell Lung Cancer
🗓️ Study Start (Actual) December 2014
🗓️ Primary Completion (Estimated) July 2024
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 12
🔬 Study Type INTERVENTIONAL
📊 Phase EARLY_PHASE1
Locations:
📍 Syracuse, New York, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 16 March 2015
  • First Submitted that Met QC Criteria 30 November 2015
  • First Posted 2 December 2015

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 March 2024
  • Last Update Posted 25 March 2024
  • Last Verified March 2024