Phase I IGART Study Using Active Breathing Control and Simultaneous Boost for Patients With NSCLC

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Brief Title

Phase I IGART Study Using Active Breathing Control and Simultaneous Boost for Patients With NSCLC

Official Title

A Phase I Image-Guided Adaptive Radiotherapy Study Using Active Breathing Control (ABC) and Simultaneous Integrated Boost for Patients With Inoperable Non-Small Cell Lung Cancer

Brief Summary

      This phase I trial studies the side effects and best dose of image-guided adaptive radiation
      therapy using active breathing control when given together with chemotherapy and simultaneous
      integrated boost in treating patients with stage IIA-IIIB non-small cell lung cancer that
      cannot be removed by surgery. Image-guided adaptive radiation therapy aims radiation therapy
      right at the tumor so that higher radiation doses can be given without causing bad side
      effects. Giving these higher doses may help control the tumor better. Breathing causes organs
      and tissues, including the tumor, to move within the chest. Active breathing control may
      reduce the volume that needs to be treated. Drugs used in chemotherapy, such as paclitaxel
      and carboplatin, work in different ways to stop the growth of tumor cells, either by killing
      the cells or by stopping them from dividing. Giving image-guided adaptive radiation therapy
      using active breathing control with chemotherapy and simultaneous integrated boost may be an
      effective treatment for non-small cell lung cancer.
    

Detailed Description

      OUTLINE: This is a dose-escalation study of IGART.

      Patients undergo IGART using active breathing control (ABC) 5 days a week for 7 weeks, for a
      total of 33 fractions with simultaneous integrated volume adapted boost (SIVAB) during
      fractions 26-33. Patients also receive paclitaxel intravenously (IV) over 1 hour and
      carboplatin IV over 30 minutes once a week for 6 weeks.

      After completion of study treatment, patients are followed up periodically for 5 years.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

MTD, defined as the highest dose level at which =< 3 out of 7 patients experience a dose-limiting toxicity

Secondary Outcome

 Incidence of acute toxicity measured using the National Cancer Institution Common Terminology for Adverse Events version 4.0

Condition

Adenocarcinoma of the Lung

Intervention

Paclitaxel

Study Arms / Comparison Groups

 Treatment (IGART using ABC, SIVAB, paclitaxel, carboplatin)
Description:  Patients undergo IGART using ABC 5 days a week for 7 weeks, for a total of 33 fractions with SIVAB during fractions 26-33. Patients also receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once a week for 6 weeks.

Publications

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

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

0

Start Date

March 2014

Completion Date

January 2015

Primary Completion Date

January 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically-proven (by biopsy or cytology), unresectable or inoperable lung cancer
             of the following histologic types: squamous cell carcinoma, adenocarcinoma, large cell
             carcinoma, non-small cell carcinoma not otherwise specified.

          -  The tumor stage must be Stage IIA-IIIB (AJCC 7th edition). See
             http://aboutcancer.com/AJCC 7th lung 1.gif and http://aboutcancer.com/AJCC 7th lung
             2.gif for staging.

          -  All detectable tumor must be encompassed by radiation therapy fields.

          -  18-fluorodeoxyglucose PET is required for staging and treatment planning.

          -  Atelectasis, if present, must involve less than a complete lung.

          -  Laboratory values:

               -  Neutrophils >1500/µL

               -  Platelets >100,000/µL

               -  Bilirubin < 1.5 mg/dL

               -  Aspartate aminotransferase (AST; formerly serum glutamic oxaloacetic transaminase
                  [SGOT]) < 2x upper limit normal

               -  Alanine aminotransferase (ALT; formerly serum glutamic pyruvic transaminase
                  [SGPT]) < 2x upper limit normal

               -  Serum creatinine < 2.0 mg/dL

               -  Glomerular filtration rate (GFR) calculated (kidney function test) within 30 days
                  must be ≥ 59 mL/min

               -  Pulmonary function test (PFT) with FEV-1 ≥ 1.0 L/sec

          -  Plan of curative radiotherapy with or without concurrent chemotherapy.

          -  Karnofsky Performance Scale score of ≥ 70%.

          -  Age ≥ 18 years old.

          -  Measurable disease on the planning CT.

          -  Patient must have a completed IMRT plan to 66 Gy in 2 Gy fractions with ≥ 95% of the
             PTV covered by the prescription dose, and the attending physician must have reviewed
             and approved the DVHs as follows:

               -  total lung V20 Gy ≤ 30%

               -  mean esophageal dose ≤ 34 Gy

               -  esophageal planning organs-at-risk volume (PRV) V60 Gy ≤ 30%

               -  heart V40 Gy ≤ 50%

               -  maximum brachial plexus dose ≤ 66 Gy

               -  maximum spinal cord PRV dose ≤ 50 Gy

               -  maximum aorta dose ≤ 66 Gy

               -  maximum main bronchus dose ≤ 66 Gy

               -  maximum dose ≥ 66 Gy allowed in only one lobar bronchus.

          -  Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  Complete tumor resection, recurrent disease, or those patients eligible for definitive
             surgery.

          -  Prior radiation therapy to the thorax.

          -  Previous chemotherapy or previous biologic response modifiers for current lung cancer
             or within the past 5 years.

          -  Clinically significant pleural effusions, pericardial effusions, or superior vena cava
             syndrome.

          -  Oxygen supplementation required during therapy.

          -  Involvement of the brachial plexus, or infiltration of the aorta, heart, or esophagus.

          -  Tumors that affect more than one lobar bronchus, except the second involved bronchus
             in the right middle lobe bronchus.

          -  Unable to perform the BH procedures, unless tumor motion is ≤ 3 mm.

          -  Myocardial infarction within the last 6 months, symptomatic heart disease,
             uncompensated chronic obstructive pulmonary disease (COPD), or uncontrolled
             bronchospasms.

          -  History of a prior malignancy from which the patient has not been disease free for a
             minimum of 2 years, other than adequately treated basal/squamous skin cancer or in
             situ cervix cancer or other in situ malignancy.

          -  Pregnant or lactating women.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Elisabeth Weiss, MD, , 



Administrative Informations


NCT ID

NCT02059967

Organization ID

MCC-13-09209

Secondary IDs

HM20000101

Responsible Party

Sponsor

Study Sponsor

Virginia Commonwealth University

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Elisabeth Weiss, MD, Principal Investigator, Virginia Commonwealth University


Verification Date

March 2015