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

NCIC Clinical Trials Group

Status

Completed

Conditions

Lung Cancer

Treatments

Radiation: 3-dimensional conformal radiation therapy

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT00346320

BR25

CAN-NCIC-BR25 (Other Identifier)

CDR0000486919 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)