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

Brief Title

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

Official Title

Image-Guided Hypofractionated Radiotherapy With Stereotactic Boost and Chemotherapy for Inoperable Stage II-III Non-Small Cell Lung Cancer

Brief 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
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To determine the maximum tolerated dose (MTD) using hypofractionated RT in patients with
      stage II-III NSCLC.

      SECONDARY OBJECTIVES:

      I. To determine the dose-limiting toxicity, if the MTD is reached.

      II. To determine the tumor local control (LC).

      III. To determine the lung cancer disease specific survival (DSS).

      IV. To determine the overall survival (OS).

      V. To assess the transforming growth factor-beta (TGF-B), interleukin (IL)-1, and IL-6 levels
      as predictive biomarkers for treatment induced tissue injury.

      OUTLINE: This is a dose-escalation study of image-guided hypofractionated RT.

      Patients undergo image-guided hypofractionated RT over 35 minutes 5 days a week for 2 weeks
      followed by 5 fractions of hypofractionated RT boost. Patients also receive standard
      carboplatin and paclitaxel for 3 weeks.

      After completion of study treatment, patients are followed up at 4-6 weeks, every 3 months
      for the first 2 years, and then periodically thereafter.
    

Study Type

Interventional

Primary Outcome

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

Secondary Outcome

 To determine tumor Local control

Condition

Adenocarcinoma of the Lung

Intervention

hypofractionated radiation therapy

Study Arms / Comparison Groups

 Treatment (dose-escalation of RT)

Description:  Patients undergo image-guided hypofractionated RT over 35 minutes 5 days a week for 2 weeks followed by 5 fractions of hypofractionated RT boost. Patients also receive standard carboplatin and paclitaxel for 3 weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Radiation

Estimated Enrollment

29

Start Date

March 23, 2011

Completion Date

May 1, 2021

Primary Completion Date

December 31, 2020

Eligibility Criteria

        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 study
             period and for up to 4 weeks after the study treatment

          -  Refusal to sign the informed consent

          -  Patients who are participating in a concurrent treatment protocol
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Percy Lee, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT01345851

Organization ID

10-001342

Secondary IDs

NCI-2011-00673

Responsible Party

Sponsor

Study Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Percy Lee, Principal Investigator, Jonsson Comprehensive Cancer Center

Verification Date

June 2020