Radiation Therapy in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
This study is ongoing, but not recruiting participants.
Sponsor:
NCIC Clinical Trials Group
Information provided by (Responsible Party):
NCIC Clinical Trials Group
ClinicalTrials.gov Identifier:
NCT00346320
First received: June 28, 2006
Last updated: November 26, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Radiation: 3-dimensional conformal radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Further study details as provided by NCIC Clinical Trials Group:
Primary Outcome Measures:
- Local tumor control rate at 2 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]Overall tumor control rate will be assessed at 6 years
Secondary Outcome Measures:
- Toxicity [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
- Disease recurrence rates [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: 6 years ] [ Designated as safety issue: No ]
- Changes in pulmonary function [ Time Frame: 6 years ] [ Designated as safety issue: No ]
| Enrollment: | 80 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | July 2013 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Radiotherapy
3-dimensional conformal radiotherapy, 60 Gy in once daily 4 Gy fractions (Monday to Friday) over 3 weeks
|
Radiation: 3-dimensional conformal radiation therapy
3-dimensional conformal radiotherapy, 60 Gy in once daily 4 Gy fractions (Monday to Friday) over 3 weeks
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00346320
Locations
| Canada, Alberta | |
| Tom Baker Cancer Centre | |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Canada, British Columbia | |
| BCCA - Cancer Centre for the Southern Interior | |
| Kelowna, British Columbia, Canada, V1Y 5L3 | |
| BCCA - Fraser Valley Cancer Centre | |
| Surrey, British Columbia, Canada, V3V 1Z2 | |
| BCCA - Vancouver Cancer Centre | |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| BCCA - Vancouver Island Cancer Centre | |
| Victoria, British Columbia, Canada, V8R 6V5 | |
| Canada, Manitoba | |
| CancerCare Manitoba | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, New Brunswick | |
| Atlantic Health Sciences Corporation | |
| Saint John, New Brunswick, Canada, E2L 4L2 | |
| Canada, Newfoundland and Labrador | |
| Dr. H. Bliss Murphy Cancer Centre | |
| St. John's, Newfoundland and Labrador, Canada, AIB 3V6 | |
| Canada, Nova Scotia | |
| QEII Health Sciences Center | |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Canada, Ontario | |
| Juravinski Cancer Centre at Hamilton Health Sciences | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Cancer Centre of Southeastern Ontario at Kingston | |
| Kingston, Ontario, Canada, K7L 5P9 | |
| London Regional Cancer Program | |
| London, Ontario, Canada, N6A 4L6 | |
| Lakeridge Health Oshawa | |
| Oshawa, Ontario, Canada, L1G 2B9 | |
| Thunder Bay Regional Health Science Centre | |
| Thunder Bay, Ontario, Canada, P7B 6V4 | |
| Odette Cancer Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Canada, Quebec | |
| McGill University - Dept. Oncology | |
| Montreal, Quebec, Canada, H2W 1S6 | |
| CHUM - Hopital Notre-Dame | |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Hopital Maisonneuve-Rosemont | |
| Montreal, Quebec, Canada, H1T 2M4 | |
| CHUQ-Pavillon Hotel-Dieu de Quebec | |
| Quebec City, Quebec, Canada, G1R 2J6 | |
Sponsors and Collaborators
NCIC Clinical Trials Group
Investigators
| Study Chair: | Patrick C. F. Cheung, MD, FRCPC | Edmond Odette Cancer Centre at Sunnybrook |
| Study Chair: | Sergio L. Faria, MD, PhD | Montreal General Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | NCIC Clinical Trials Group |
| ClinicalTrials.gov Identifier: | NCT00346320 History of Changes |
| Other Study ID Numbers: | BR25, CAN-NCIC-BR25, CDR0000486919 |
| Study First Received: | June 28, 2006 |
| Last Updated: | November 26, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by NCIC Clinical Trials Group:
|
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 |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013