Active — Not RecruitingNot Applicable

Image-Guided Hypofractionated Radiation Therapy With Stereotactic Body Radiation Therapy Boost and Combination Chemotherapy in Treating Patients With Stage II-III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery

United States29 participantsStarted 2011-03-23

Plain-language summary

This clinical trial studies image-guided hypofractionated radiation therapy (RT) when given together with hypofractionated RT boost and combination chemotherapy in treating patients with stage II-III non-small cell lung cancer (NSCLC) that cannot be removed by surgery. RT uses high energy x-rays to kill tumor cells. Hypofractionated RT may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving RT together with combination chemotherapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histologically confirmed primary non-metastatic NSCLC; eligible histological subtypes include: squamous cell carcinoma, adenocarcinoma, squamous-adeno carcinoma, large-cell carcinoma, and non-small cell carcinoma not otherwise specified * Clinical stage II and III NSCLC as defined by American Joint Committee on Cancer (AJCC) Cancer Staging Manual, seventh edition; acceptable imaging modalities to document nodal positivity include computed tomography (CT) chest, positron emission tomography (PET)-CT, or thoracic magnetic resonance imaging (MRI) * For clinically stage II patients, the patient must have been evaluated by a thoracic surgeon, and deemed medically or technically inoperable, or the patient must refuse surgery * Karnofsky performance status \>= 70 * If a woman is of childbearing potential, a negative serum pregnancy test must be documented; women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study treatment and for up to 4 weeks following the study treatment Exclusion Criteria: * Patients who have previously received therapeutic radiation therapy to the chest * Active systemic, pulmonary, or pericardial infection * Use of concurrent gemcitabine-based chemotherapy during radiotherapy * Pregnant women, or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire st…

What they're measuring

To determine the maximal tolerated dose using hypofractionated radiotherapy in patients with stage II-III non small cell lung cancer.

Timeframe: up to 90 days

Trial details

NCT IDNCT01345851

SponsorJonsson Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-31