Gated Intensity Modulated Radiation Therapy and Concurrent Chemotherapy for Inoperable NSCLC

This study has been terminated.
(insufficient accrual)
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00692380
First received: June 3, 2008
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

Radiation therapy technology that allows increased radiation dose to the tumor while sparing healthy tissue will improve the balance between complications and cure.


Condition Intervention Phase
Non-small Cell Lung Cancer
Radiation: Fractionated radiation therapy followed by chemotherapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Dose Intensification Study Using Gated Intensity Modulated Radiation Therapy and Concurrent Chemotherapy for Patients With Inoperable, Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Maximum tolerated dose [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 28
Study Start Date: June 2006
Study Completion Date: June 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Fractionated Radiation Therapy followed by Carboplatin and Taxol
Radiation: Fractionated radiation therapy followed by chemotherapy
Increasing doses of radiation therapy

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00692380

Locations
United States, Virginia
Massey Cancer Center
Richmond, Virginia, United States, 23219
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Elisabeth Weiss, M.D. Massey Cancer Center
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00692380     History of Changes
Other Study ID Numbers: MCC-10274
Study First Received: June 3, 2008
Last Updated: April 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
gated IMRT

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014