Lung CancerNCT00346320
Radiation in Stage I or Stage II Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery
A study testing 3-dimensional conformal radiation therapy in people with Lung Cancer, run by NCIC Clinical Trials Group at 19 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- 3-dimensional conformal radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 19 sitesCanada
- Study dates
- 2 Aug 2006to 20 Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Canada19 sites
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
QEII Health Sciences Center
Halifax, Nova Scotia, B3H 1V7
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2
BCCA - Cancer Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, K7L 5P9
London Regional Cancer Program
London, Ontario, N6A 4L6
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
CHUM - Hopital Notre-Dame
Montreal, Quebec, H2L 4M1
McGill University - Dept. Oncology
Montreal, Quebec, H2W 1S6
Lakeridge Health Oshawa
Oshawa, Ontario, L1G 2B9
CHUQ-Pavillon Hotel-Dieu de Quebec
Québec, Quebec, G1R 2J6
Atlantic Health Sciences Corporation
Saint John, New Brunswick, E2L 4L2
Dr. H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, AIB 3V6
BCCA - Fraser Valley Cancer Centre
Surrey, British Columbia, V3V 1Z2
Thunder Bay Regional Health Science Centre
Thunder Bay, Ontario, P7B 6V4
Odette Cancer Centre
Toronto, Ontario, M4N 3M5
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
BCCA - Vancouver Island Cancer Centre
Victoria, British Columbia, V8R 6V5
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
About this study
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)
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.
Read the 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
- Being tested
- 3-dimensional conformal radiation therapy
- Keywords
- 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
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-dimensional conformal radiation therapyRadiation
3-dimensional conformal radiotherapy, 60 Gy in once daily 4 Gy fractions (Monday to Friday) over 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy | Experimental | 3-dimensional conformal radiotherapy, 60 Gy in once daily 4 Gy fractions (Monday to Friday) over 3 weeks Receives: Radiation: 3-dimensional conformal radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local tumor control rate at 2 years
Overall tumor control rate will be assessed at 6 years
Measured: 2 years
Secondary outcomes (6)
Toxicity
Measured: 6 years
Disease recurrence rates
Measured: 6 years
Progression-free survival
Measured: 6 years
Overall survival
Measured: 6 years
Quality of life
Measured: 6 years
Changes in pulmonary function
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2006 (estimated)
- Study start2 Aug 2006
- Primary completion28 Feb 2012
- Study completion20 Aug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- NCIC Clinical Trials Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Patrick CF Cheung, MD, FRCPC, Study chair, Toronto Sunnybrook Regional Cancer CentreSergio L Faria, MD, PhD, Study chair, Montreal General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00346320
- Sponsor's protocol ID
- BR25
- Other IDs
- CAN-NCIC-BR25, CDR0000486919
- Status last verified
- Apr 2020
- First submitted
- 28 Jun 2006
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25074417
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00346320
- Acronym / sponsor ID
- BR25
- Conditions
- Lung Cancer
- Keywords
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- NCIC Clinical Trials GroupResearch network
- Study start
- 2 Aug 2006 (actual)
- Primary completion
- 28 Feb 2012 (actual)
- Study completion
- 20 Aug 2014 (actual)
- First posted
- 29 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy | Experimental | Radiation: 3-dimensional conformal radiation therapy3-dimensional conformal radiotherapy, 60 Gy in once daily 4 Gy fractions (Monday to Friday) over 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-dimensional conformal radiation therapy3-dimensional conformal radiotherapy, 60 Gy in once daily 4 Gy fractions (Monday to Friday) over 3 weeks | Radiation | Radiotherapy |
Primary outcome
Local tumor control rate at 2 years
Time frame: 2 years
Overall tumor control rate will be assessed at 6 years
6 secondary outcomes
Toxicity
Time frame: 6 years
Disease recurrence rates
Time frame: 6 years
Progression-free survival
Time frame: 6 years
Overall survival
Time frame: 6 years
Quality of life
Time frame: 6 years
Changes in pulmonary function
Time frame: 6 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Results publication: PubMed 25074417Cheung 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick CF Cheung, MD, FRCPC study chair
Toronto Sunnybrook Regional Cancer Centre
Sergio L Faria, MD, PhD study chair
Montreal General Hospital
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3-dimensional conformal radiation therapy in people with Lung Cancer, run by NCIC Clinical Trials Group at 19 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local tumor control rate at 2 years (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00346320, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.