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Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
accelerated conformational radiotherapy
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage I non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage I (T1-2, N0) non-small cell lung cancer (NSCLC) Squamous cell carcinoma Basaloid carcinoma Adenocarcinoma Bronchoalveolar carcinoma Adenosquamous carcinoma Large cell carcinoma Large cell neuroendocrine carcinoma Giant cell carcinoma Sarcomatoid carcinoma Non-small cell carcinoma not otherwise specified Tridimensionally measurable solitary parenchymal lung lesion no greater than 4 cm in diameter by chest CT scan (lung windows) No metastatic disease or hilar or mediastinal lymphadenopathy Must have mediastinoscopy* (anterior, cervical, or both) if mediastinal lymph nodes are greater than 1.0 cm in diameter by chest CT scan No positive lymph nodes on mediastinoscopy* NOTE: *Patients may have positron-emission tomography in lieu of mediastinoscopy provided there is no fludeoxyglucose F 18 uptake in the mediastinum and hilum Poor surgical risk, as defined by 1 of the following: High risk due to nonpulmonary reasons, such as renal failure, cardiac failure, or hepatic dysfunction and deemed by thoracic surgeon to be unsuitable for lobectomy Pulmonary dysfunction indicated by one or more of the following: FEV_1 less than 40% of predicted DLCO less than 50% of predicted Oxygen dependent Chronic PaCO_2 greater than 45 mm Hg VO_2 less than 15 mL/kg/min PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-2 Other: Not pregnant or nursing Fertile patients must use effective contraception No weight loss of more than 10% within the past 6 months No other active (less than 30% risk of relapse after completion of prior therapy) malignancy except nonmelanoma skin cancer Chemotherapy: No prior chemotherapy for NSCLC Radiotherapy: No prior chest radiotherapy

Sites / Locations

  • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
  • Memorial Cancer Institute at Memorial Regional Hospital
  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center
  • CCOP - Mount Sinai Medical Center
  • University of Chicago Cancer Research Center
  • Fairview University Medical Center - University Campus
  • Saint Luke's Hospital
  • Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
  • Great Plains Regional Medical Center
  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center
  • Veterans Affairs Medical Center - Buffalo
  • Oswego Hospital
  • CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
  • St. Joseph's Hospital Health Center - Syracuse
  • SUNY Upstate Medical University Hospital
  • Blumenthal Cancer Center at Carolinas Medical Center
  • Wayne Memorial Hospital, Incorporated
  • Comprehensive Cancer Center at Wake Forest University
  • Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
  • Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiotherapy

Arm Description

Patients receive accelerated 3-dimensional (3-D) conformal radiotherapy daily 5 days a week for 3.5-6 weeks. Cohorts of 8 patients receive escalating fractions of accelerated 3-D conformal radiotherapy until the maximum tolerated course is determined. The maximum tolerated course is defined as the course at which no more than 2 patients develop at least grade 3 dose-limiting toxicity and no more than 1 patient develops at least grade 4 dose-limiting toxicity. Patients are followed at 3 weeks, 6 weeks, 3 months, every 3 months for 2 years, and then every 6 months for 3 years.

Outcomes

Primary Outcome Measures

Overall survival
Failure-free survival

Secondary Outcome Measures

Full Information

First Posted
February 2, 2001
Last Updated
July 12, 2016
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00009789
Brief Title
Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction
Official Title
Accelerated Conformal Radiotherapy for Stage I Non-Small Cell Lung Cancer in Patients With Pulmonary Dysfunction: A Phase I Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
December 2000 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: Phase I trial to study the effectiveness of specialized high-dose radiation therapy in treating patients who have stage I non-small cell lung cancer and lung dysfunction.
Detailed Description
OBJECTIVES: Determine the maximum tolerated course of accelerated 3-dimensional conformal radiotherapy in patients with stage I non-small cell lung cancer with pulmonary dysfunction. Determine the short-term and long-term toxicity of this regimen in these patients. Determine local tumor control, failure-free survival, and overall survival in patients treated with this regimen. Determine the effect of radiotherapy dose volume relationships and pre-treatment pulmonary function studies on the incidence of pulmonary toxicity in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients receive accelerated 3-dimensional (3-D) conformal radiotherapy daily 5 days a week for 3.5-6 weeks. Cohorts of 8 patients receive escalating fractions of accelerated 3-D conformal radiotherapy until the maximum tolerated course is determined. The maximum tolerated course is defined as the course at which no more than 2 patients develop at least grade 3 dose-limiting toxicity and no more than 1 patient develops at least grade 4 dose-limiting toxicity. Patients are followed at 3 weeks, 6 weeks, 3 months, every 3 months for 2 years, and then every 6 months for 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage I non-small cell lung cancer, squamous cell lung cancer, large cell lung cancer, adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiotherapy
Arm Type
Experimental
Arm Description
Patients receive accelerated 3-dimensional (3-D) conformal radiotherapy daily 5 days a week for 3.5-6 weeks. Cohorts of 8 patients receive escalating fractions of accelerated 3-D conformal radiotherapy until the maximum tolerated course is determined. The maximum tolerated course is defined as the course at which no more than 2 patients develop at least grade 3 dose-limiting toxicity and no more than 1 patient develops at least grade 4 dose-limiting toxicity. Patients are followed at 3 weeks, 6 weeks, 3 months, every 3 months for 2 years, and then every 6 months for 3 years.
Intervention Type
Radiation
Intervention Name(s)
accelerated conformational radiotherapy
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
Up to 5 years
Title
Failure-free survival
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage I (T1-2, N0) non-small cell lung cancer (NSCLC) Squamous cell carcinoma Basaloid carcinoma Adenocarcinoma Bronchoalveolar carcinoma Adenosquamous carcinoma Large cell carcinoma Large cell neuroendocrine carcinoma Giant cell carcinoma Sarcomatoid carcinoma Non-small cell carcinoma not otherwise specified Tridimensionally measurable solitary parenchymal lung lesion no greater than 4 cm in diameter by chest CT scan (lung windows) No metastatic disease or hilar or mediastinal lymphadenopathy Must have mediastinoscopy* (anterior, cervical, or both) if mediastinal lymph nodes are greater than 1.0 cm in diameter by chest CT scan No positive lymph nodes on mediastinoscopy* NOTE: *Patients may have positron-emission tomography in lieu of mediastinoscopy provided there is no fludeoxyglucose F 18 uptake in the mediastinum and hilum Poor surgical risk, as defined by 1 of the following: High risk due to nonpulmonary reasons, such as renal failure, cardiac failure, or hepatic dysfunction and deemed by thoracic surgeon to be unsuitable for lobectomy Pulmonary dysfunction indicated by one or more of the following: FEV_1 less than 40% of predicted DLCO less than 50% of predicted Oxygen dependent Chronic PaCO_2 greater than 45 mm Hg VO_2 less than 15 mL/kg/min PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 0-2 Other: Not pregnant or nursing Fertile patients must use effective contraception No weight loss of more than 10% within the past 6 months No other active (less than 30% risk of relapse after completion of prior therapy) malignancy except nonmelanoma skin cancer Chemotherapy: No prior chemotherapy for NSCLC Radiotherapy: No prior chest radiotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Bogart, MD
Organizational Affiliation
State University of New York - Upstate Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Memorial Cancer Institute at Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Ella Milbank Foshay Cancer Center at Jupiter Medical Center
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
CCOP - Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Fairview University Medical Center - University Campus
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Saint Luke's Hospital
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Facility Name
Great Plains Regional Medical Center
City
North Platte
State/Province
Nebraska
ZIP/Postal Code
69103
Country
United States
Facility Name
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Veterans Affairs Medical Center - Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Oswego Hospital
City
Oswego
State/Province
New York
ZIP/Postal Code
13126
Country
United States
Facility Name
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
City
Syracuse
State/Province
New York
ZIP/Postal Code
13057
Country
United States
Facility Name
St. Joseph's Hospital Health Center - Syracuse
City
Syracuse
State/Province
New York
ZIP/Postal Code
13203
Country
United States
Facility Name
SUNY Upstate Medical University Hospital
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Blumenthal Cancer Center at Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Wayne Memorial Hospital, Incorporated
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Comprehensive Cancer Center at Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224-1791
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19933904
Citation
Bogart JA, Hodgson L, Seagren SL, Blackstock AW, Wang X, Lenox R, Turrisi AT 3rd, Reilly J, Gajra A, Vokes EE, Green MR. Phase I study of accelerated conformal radiotherapy for stage I non-small-cell lung cancer in patients with pulmonary dysfunction: CALGB 39904. J Clin Oncol. 2010 Jan 10;28(2):202-6. doi: 10.1200/JCO.2009.25.0753. Epub 2009 Nov 23.
Results Reference
result

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Radiation Therapy in Treating Patients With Stage I Non-Small Cell Lung Cancer And Lung Dysfunction

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