Gated Intensity Modulated Radiation Therapy and Concurrent Chemotherapy for Inoperable NSCLC

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00692380
• Other study ID #: MCC-10274
• Status: Terminated
• Phase: Phase 1
• First received: June 3, 2008
• Last updated: April 28, 2016
• Start date: June 2006
• Est. completion date: June 2010

Study information

• Verified date: April 2016
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: June 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Intervention

Radiation:
• Fractionated radiation therapy followed by chemotherapy
Increasing doses of radiation therapy

Locations

Country	Name	City	State
United States	Massey Cancer Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose		3 years	Yes
Secondary	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.		3 years	Yes