Study on Hypofractionated Proton Therapy for Stage II-III Non-Small Cell Lung Cancer

Sponsor: Proton Collaborative Group

Sponsor score: 0

ClinicalTrials ID:NCT01770418

Provider View

This clinical trial is exploring a new way to treat stage II-III non-small cell lung cancer by combining standard chemotherapy with a special type of radiation therapy called hypofractionated proton therapy. This method uses higher doses of radiation over a shorter time to see if it can improve treatment outcomes.

Patient Parameters

Program Overview

The aim of this study is to compare the effects of standard chemotherapy combined with hypofractionated proton radiation therapy on patients with stage II-III non-small cell lung cancer (NSCLC). Hypofractionation involves delivering higher doses of radiation in fewer sessions. Researchers hope this approach will improve local control of the cancer and overall survival rates, while reducing the time patients spend receiving less aggressive chemotherapy. Proton therapy is a precise form of radiation that minimizes damage to surrounding healthy tissues, potentially reducing side effects compared to traditional methods.

Description

This study is investigating a new treatment approach for patients with stage II-III non-small cell lung cancer (NSCLC). The current standard treatment involves chemotherapy and conventional radiation therapy, which has a moderate success rate but can cause significant side effects. Researchers are testing whether using higher doses of radiation over a shorter period, known as hypofractionated proton therapy, can improve outcomes. Proton therapy is a type of radiation that targets tumors more precisely, potentially reducing harm to healthy tissues.

The study will assess the safety and effectiveness of this combined treatment approach. By delivering radiation in fewer sessions, the hope is to improve cancer control and survival rates, while also shortening the duration of less intensive chemotherapy. This could lead to better overall outcomes for patients with stage II-III NSCLC.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of invasive non-small cell lung cancer within the last 12 weeks, or within 6 months if the patient had prior chemotherapy.
  • Cancer stage II-III according to the American Joint Committee on Cancer (AJCC) guidelines.
  • Good overall health with an ECOG performance status of 0 or 1.
  • Must provide informed consent to participate in the study.
  • Must be 18 years or older.
  • Completion of all required medical tests before joining the study.
  • Specific blood test results within normal ranges, including:
    • Neutrophil count above 1,800 cells/mm3.
    • Platelet count of at least 100,000 cells/mm3.
    • Hemoglobin level of at least 10 g/dl.
    • Liver enzymes (AST/SGOT and ALT/SGPT) within 2.5 times the normal limit.
  • Any exploratory chest surgery must have been done more than 3 weeks before joining the study.
  • Lung function test showing FEV1 above 0.75 liters/second.
  • Must be evaluated by a specialist and deemed not suitable for surgery.

Exclusion Criteria

  • Cancer has spread to distant parts of the body.
  • Previous radiation treatment to the chest area.
  • Unintentional weight loss of more than 10% in the last 4 weeks.
  • Pregnant or breastfeeding women, or those not willing to use contraception during and for 12 months after treatment. Pregnancy testing is not needed for women who have had a hysterectomy or have not had a period for at least 24 months.

Locations

FACILITYZIPCITYSTATE
University of Florida Proton Therapy Institute32206JacksonvilleFlorida
Northwestern Medicine Chicago Proton Center60555WarrenvilleIllinois
Maryland Proton Treatment Center21201BaltimoreMaryland
Princeton ProCure Management LLC08873SomersetNew Jersey
Oklahoma Proton Center73142Oklahoma CityOklahoma
Hampton University Proton Therapy Institute23666HamptonVirginia

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