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

Lung Cancer Clinical Trial

Official title:

Accelerated Conformal Radiotherapy for Stage I Non-Small Cell Lung Cancer in Patients With Pulmonary Dysfunction: A Phase I Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00009789
• Other study ID #: CALGB-39904
• Secondary ID: U10CA076001CALGB
• Status: Completed
• Phase: Phase 1
• First received: February 2, 2001
• Last updated: July 12, 2016
• Start date: December 2000
• Est. completion date: June 2010

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 2010
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Radiation:
• accelerated conformational radiotherapy

Locations

Country	Name	City	State
United States	Veterans Affairs Medical Center - Buffalo	Buffalo	New York
United States	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina
United States	Saint Luke's Hospital	Chesterfield	Missouri
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University	Columbus	Ohio
United States	Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital	Fort Lauderdale	Florida
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	Saint Francis Cancer Treatment Center at Saint Francis Memorial Health Center	Grand Island	Nebraska
United States	Memorial Cancer Institute at Memorial Regional Hospital	Hollywood	Florida
United States	Ella Milbank Foshay Cancer Center at Jupiter Medical Center	Jupiter	Florida
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	Fairview University Medical Center - University Campus	Minneapolis	Minnesota
United States	Great Plains Regional Medical Center	North Platte	Nebraska
United States	UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Omaha	Nebraska
United States	Oswego Hospital	Oswego	New York
United States	Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.	Syracuse	New York
United States	St. Joseph's Hospital Health Center - Syracuse	Syracuse	New York
United States	SUNY Upstate Medical University Hospital	Syracuse	New York
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Bogart J, Watson D, Seagren S, et al.: Accelerated conformal radiotherapy for stage I non-small cell lung cancer (NSCLC) in patients with pulmonary dysfunction: a CALGB phase I study. [Abstract] J Clin Oncol 25 (Suppl 18): A-7556, 398s, 2007.

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: CAL — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		Up to 5 years	No
Primary	Failure-free survival		Up to 5 years	No