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

Phase 2
18 Years
Open (Enrolling)
Lung Cancer

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Trial Information

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



- 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.


- 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

- 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.

Inclusion Criteria


- 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

- 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

- 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

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

- No ataxia telangiectasia


- 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

- 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)


- No prior radiotherapy to the area of the primary tumor

- No prior or concurrent chemotherapy or immunotherapy for this tumor

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local tumor control rate at 2 years

Outcome Description:

Overall tumor control rate will be assessed at 6 years

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Patrick C. F. Cheung, MD, FRCPC

Investigator Role:

Study Chair

Investigator Affiliation:

Edmond Odette Cancer Centre at Sunnybrook


Canada: Health Canada

Study ID:




Start Date:

April 2006

Completion Date:

July 2013

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • stage II non-small cell lung cancer
  • adenocarcinoma of the lung
  • adenosquamous cell lung cancer
  • bronchoalveolar cell lung cancer
  • large cell lung cancer
  • squamous cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms