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

NCT ID: NCT00346320

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-02
• Study Completion Date: 2014-08-20

Brief 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.

Detailed 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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiotherapy

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

Group Type: EXPERIMENTAL

3-dimensional conformal radiation therapy

Intervention Type: RADIATION

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

Interventions

3-dimensional conformal radiation therapy

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

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NCIC Clinical Trials Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick CF Cheung, MD, FRCPC

Role: STUDY_CHAIR

Toronto Sunnybrook Regional Cancer Centre

Sergio L Faria, MD, PhD

Role: STUDY_CHAIR

Montreal General Hospital

Locations

Tom Baker Cancer Centre

Calgary, Alberta, Canada

BCCA - Cancer Centre for the Southern Interior

Kelowna, British Columbia, Canada

BCCA - Fraser Valley Cancer Centre

Surrey, British Columbia, Canada

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, Canada

BCCA - Vancouver Island Cancer Centre

Victoria, British Columbia, Canada

CancerCare Manitoba

Winnipeg, Manitoba, Canada

Atlantic Health Sciences Corporation

Saint John, New Brunswick, Canada

Dr. H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, Canada

QEII Health Sciences Center

Halifax, Nova Scotia, Canada

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, Canada

Cancer Centre of Southeastern Ontario at Kingston

Kingston, Ontario, Canada

London Regional Cancer Program

London, Ontario, Canada

Lakeridge Health Oshawa

Oshawa, Ontario, Canada

Thunder Bay Regional Health Science Centre

Thunder Bay, Ontario, Canada

Odette Cancer Centre

Toronto, Ontario, Canada

Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

CHUM - Hopital Notre-Dame

Montreal, Quebec, Canada

McGill University - Dept. Oncology

Montreal, Quebec, Canada

CHUQ-Pavillon Hotel-Dieu de Quebec

Québec, Quebec, Canada

Countries

Canada

References

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 three-dimensional conformal radiotherapy for stage T1-3 N0 M0 non-small cell lung cancer: NCIC CTG BR.25. J Natl Cancer Inst. 2014 Jul 29;106(8):dju164. doi: 10.1093/jnci/dju164. Print 2014 Aug.

Reference Type: RESULT

PMID: 25074417 (View on PubMed)

Other Identifiers

CAN-NCIC-BR25

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000486919

Identifier Type: OTHER

Identifier Source: secondary_id

BR25

Identifier Type: -

Identifier Source: org_study_id