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Gated Intensity Modulated Radiation Therapy and Concurrent Chemotherapy for Inoperable NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00692380
Recruitment Status : Terminated (insufficient accrual)
First Posted : June 6, 2008
Last Update Posted : May 2, 2016
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Tracking Information
First Submitted Date  ICMJE June 3, 2008
First Posted Date  ICMJE June 6, 2008
Last Update Posted Date May 2, 2016
Study Start Date  ICMJE June 2006
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2008)
Maximum tolerated dose [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2008)
To identify partial organ tolerance doses for lung and esophagus when treating with involved field thoracic 3D. To estimate complete response rate as defined by PET performed 3 months after completion of all therapy. [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gated Intensity Modulated Radiation Therapy and Concurrent Chemotherapy for Inoperable NSCLC
Official Title  ICMJE A Phase I Dose Intensification Study Using Gated Intensity Modulated Radiation Therapy and Concurrent Chemotherapy for Patients With Inoperable, Non-Small Cell Lung Cancer
Brief Summary Radiation therapy technology that allows increased radiation dose to the tumor while sparing healthy tissue will improve the balance between complications and cure.
Detailed Description The primary objective is to establish the maximum tolerated fractional dose (MTfD) of radiotherapy to a total dose of 78Gy using gated IMRT, delivered in single daily fractions that can be administered concurrently with Taxol® and carboplatin chemotherapy. Secondary objectives include: to evaluate the toxicity of concurrent Taxol® and carboplatin with gated IMRT; identify partial organ tolerance doses for lung and esophagus when treating with involved field thoracic 3D; estimate complete response rate as defined by PET performed 3 months after completion of all therapy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-small Cell Lung Cancer
Intervention  ICMJE Radiation: Fractionated radiation therapy followed by chemotherapy
Increasing doses of radiation therapy
Study Arms  ICMJE Experimental: A
Fractionated Radiation Therapy followed by Carboplatin and Taxol
Intervention: Radiation: Fractionated radiation therapy followed by chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 23, 2013)
28
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2008)
24
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with histologically-proven, by biopsy or cytology, unresectable lung cancer of the following histologic types: squamous cell carcinoma, adenocarcinoma, large cell carcinoma, non-small cell carcinoma, not otherwise specified.
  • Patient with AJCC Stage IIIA-IIIB, if all detectable tumor can be encompassed by radiation therapy fields, including both the primary tumor and the involved regional lymph nodes.
  • 18-fluoro-2-deoxyglucose positron emission tomography required for staging and image fusion for treatment planning.
  • Atelectasis, if present, must be less than one lung.
  • Patients must have granulocytes >1500/µl; platelets >100,000/µl; bilirubin < 1.5 mg/dl; AST(SGOT) < 2 ULN; serum creatinine < 2.0 mg/dl.
  • Zubrod Score 0-1.
  • FEV1 must be >1.0 L.
  • Patients must sign a study-specific informed consent form prior to study entry
  • Patients must have measurable disease on the planning CT.
  • Patient must have a completed the IMRT plan and the attending physician must have reviewed and approved the dose volume histograms as follows (based on treatment planning to the Phase 4 dose level): total lung V20 < 30%, mean esophageal dose < 34 Gy, the esophageal V55 < 30%, the heart V40 < 50%.
  • No prior or concurrent malignancy except non-melanomatous skin cancer unless disease-free for one year or more; no prior lung cancer within last two years.
  • No prior RT to thorax.
  • No previous chemotherapy or previous biologic response modifiers for current lung cancer or within the past five (5) years.
  • No distant metastases or supraclavicular lymph node involvement or significant atelectasis.
  • No clinically significant pleural effusions, pericardial effusions or superior vena cava syndrome.

Exclusion Criteria:

  • Undifferentiated small cell (oat cell or high grade neuroendocrine) carcinoma, any stage.
  • Stage I, II or IV NSCLC.
  • Complete tumor resection, recurrent disease, or those patients eligible for definitive surgery.
  • Concurrent malignancy except non-melanomatous skin cancer or prior cancer unless disease-free for one year or more.
  • Prior radiation therapy to the thorax.
  • Previous chemotherapy or previous biologic response modifiers for current lung cancer or within the past five (5) years.
  • Distant metastases or supraclavicular lymph node involvement, or atelectasis of an entire lung.
  • Patients who have not had the pre-treatment evaluations in Section 4.0 or evaluations performed > 8 weeks prior to study entry.
  • Patients with clinically significant pleural effusions, pericardial effusions or superior vena cava syndrome.
  • Prior lung cancer within the last two years.
  • Patients who have significant atelectasis and in whom the CT definition of the gross tumor volume(GTV) is difficult to determine.
  • Pregnant or lactating females. It is not known what effects this treatment may have on the developing fetus.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00692380
Other Study ID Numbers  ICMJE MCC-10274
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Elisabeth Weiss, M.D. Massey Cancer Center
PRS Account Virginia Commonwealth University
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP