Gated Intensity Modulated Radiation Therapy and Concurrent Chemotherapy for Inoperable NSCLC

• ClinicalTrials.gov Identifier: NCT00692380
• Recruitment Status: Terminated
• First Posted: June 6, 2008
• Last Update Posted: May 2, 2016
• Sponsor: Virginia Commonwealth University
• Information provided by (Responsible Party): Virginia Commonwealth University

Tracking Information

• First Submitted Date: June 3, 2008
• First Posted Date: June 6, 2008
• Last Update Posted Date: May 2, 2016
• Study Start Date: June 2006
• Actual Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 3, 2008): Maximum tolerated dose [ Time Frame: 3 years ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Gated Intensity Modulated Radiation Therapy and Concurrent Chemotherapy for Inoperable NSCLC
• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Non-small Cell Lung Cancer

Intervention

Radiation: Fractionated radiation therapy followed by chemotherapy

Increasing doses of radiation therapy

Study Arms

Experimental: A

Fractionated Radiation Therapy followed by Carboplatin and Taxol

Intervention: Radiation: Fractionated radiation therapy followed by chemotherapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: April 23, 2013): 28
• Original Estimated Enrollment (submitted: June 3, 2008): 24
• Actual Study Completion Date: June 2010
• Actual Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00692380
• Other Study ID Numbers: MCC-10274
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Virginia Commonwealth University
• Study Sponsor: Virginia Commonwealth University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Elisabeth Weiss, M.D.; Massey Cancer Center

• PRS Account: Virginia Commonwealth University
• Verification Date: April 2016