Radiation in Stage I or Stage II Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

Lung Cancer Clinical Trial

Official title:

A Phase II Study of Accelerated Hypofractionated 3-Dimensional Conformal Radiotherapy (3DCRT) For Inoperable Stage I/II Non-Small Cell Lung Cancer (NSCLC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00346320
• Other study ID #: BR25
• Secondary ID: CAN-NCIC-BR25CDR
• Status: Completed
• Phase: N/A
• Start date: August 2, 2006
• Est. completion date: August 20, 2014

Study information

• Verified date: April 2020
• Source: Canadian Cancer Trials Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

RATIONALE: 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: This phase II trial is studying how well radiation therapy works in treating patients with stage I or stage II non-small cell lung cancer that cannot be removed by surgery.

Description:

OBJECTIVES:

Primary

• Determine the local tumor control rate at 2 years after accelerated hypofractionated 3-dimensional, conformal radiotherapy in patients with inoperable T1-3 N0 M0 non-small cell lung cancer.

Secondary

• Determine the toxicities of this regimen in these patients.

• Determine the rates of regional and distant disease recurrence in these patients.

• Determine the progression-free and overall survival of patients treated with this regimen.

• Determine the changes in pulmonary function after treatment in these patients.

• Assess the quality of life of patients after treatment.

OUTLINE: This is a multicenter, prospective study.

Patients undergo accelerated hypofractionated conformal radiotherapy 5 days a week for up to 3 weeks (15 doses) in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at week 3 of radiotherapy, at 1 month after completion of radiotherapy, and then every 4 months for 1 year.

After completion of study treatment, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 20, 2014
• Est. primary completion date: February 28, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

• Stage I or II peripheral disease

• T1, N0, M0

• T2 (= 5 cm), N0, M0

• T3 (= 5 cm, chest wall primary tumor only), N0, M0

• No T2-T3 primary tumors > 5 cm or any T1-T3 tumor of the mainstem bronchus involvement

• No T1-T3 tumor in the lung apex (i.e., tumor in a position that will result in irradiation of the brachial plexus to the prescribed dose)

• Hilar or mediastinal lymph nodes = 1 cm considered N0

• Any of the following primary cancer types:

• Squamous cell carcinoma

• Adenocarcinoma

• Large cell carcinoma

• Bronchioloalveolar cell carcinoma

• Non-small cell carcinoma not otherwise specified

• Underlying physiological medical condition that prohibits surgery due to a low probability of tolerating general anesthesia, the operation, the postoperative recovery period, or the removal of adjacent functional lung (i.e., medically inoperable)

• Cytologic specimens obtained by brushing, washing, or needle aspiration of defined lesion allowed

• If sputum cytology alone is used for diagnosis, it must be confirmed on a second specimen

• Must develop a radiotherapy plan that meets the dose-volume constraints for critical organs

• No ataxia telangiectasia

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Not pregnant or nursing

• Able and willing to complete a quality of life questionnaire unless not literate in either English or French (i.e., a translator is required to comprehend the questions and reply)

• No active systemic, pulmonary, or pericardial infection

• No previous malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix.

• Previous diagnosis of cancer that is free of recurrence and metastases for = 2 years and, in the opinion of the treating physician, does not have a substantial risk of recurrence allowed (including prior lung cancer)

PRIOR CONCURRENT THERAPY:

• No prior radiotherapy to the area of the primary tumor

• No prior or concurrent chemotherapy or immunotherapy for this tumor

Related Conditions & MeSH terms

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

Intervention

Radiation:
• 3-dimensional conformal radiation therapy
3-dimensional conformal radiotherapy, 60 Gy in once daily 4 Gy fractions (Monday to Friday) over 3 weeks

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	QEII Health Sciences Center	Halifax	Nova Scotia
Canada	Juravinski Cancer Centre at Hamilton Health Sciences	Hamilton	Ontario
Canada	BCCA - Cancer Centre for the Southern Interior	Kelowna	British Columbia
Canada	Cancer Centre of Southeastern Ontario at Kingston	Kingston	Ontario
Canada	London Regional Cancer Program	London	Ontario
Canada	CHUM - Hopital Notre-Dame	Montreal	Quebec
Canada	Hopital Maisonneuve-Rosemont	Montreal	Quebec
Canada	McGill University - Dept. Oncology	Montreal	Quebec
Canada	Lakeridge Health Oshawa	Oshawa	Ontario
Canada	CHUQ-Pavillon Hotel-Dieu de Quebec	Quebec City	Quebec
Canada	Atlantic Health Sciences Corporation	Saint John	New Brunswick
Canada	Dr. H. Bliss Murphy Cancer Centre	St. John's	Newfoundland and Labrador
Canada	BCCA - Fraser Valley Cancer Centre	Surrey	British Columbia
Canada	Thunder Bay Regional Health Science Centre	Thunder Bay	Ontario
Canada	Odette Cancer Centre	Toronto	Ontario
Canada	BCCA - Vancouver Cancer Centre	Vancouver	British Columbia
Canada	BCCA - Vancouver Island Cancer Centre	Victoria	British Columbia
Canada	CancerCare Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
NCIC Clinical Trials Group

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Cheung P, Faria S, Ahmed S, Chabot P, Greenland J, Kurien E, Mohamed I, Wright JR, Hollenhorst H, de Metz C, Campbell H, Vu TT, Karvat A, Wai ES, Ung YC, Goss G, Shepherd FA, O'Brien P, Ding K, O'Callaghan C. Phase II study of accelerated hypofractionated — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local tumor control rate at 2 years	Overall tumor control rate will be assessed at 6 years	2 years
Secondary	Toxicity		6 years
Secondary	Disease recurrence rates		6 years
Secondary	Progression-free survival		6 years
Secondary	Overall survival		6 years
Secondary	Quality of life		6 years
Secondary	Changes in pulmonary function		6 years