Breast CancerNCT00156052
Hypofractionated Radiotherapy Post-Lumpectomy in Women With Node Negative Breast Cancer
A study testing Conventional whole breast radiation schedule and Hypofractionated whole breast radiation schedule in people with Breast Cancer, run by Ontario Clinical Oncology Group (OCOG) at 11 sites in Canada.
Trial summary
To determine if hypofractionated radiotherapy to the whole breast (4,250 cGy/16 fractions over 22 days) is equally effective to standard fractionated radiotherapy (5,000 cGy/25 fractions over 35 days) in women with node negative breast cancer who have undergone lumpectomy. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Conventional whole breast radiation schedule and Hypofractionated whole breast radiation schedule
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,234 participants
- Where
- 11 sitesCanada
- Study dates
- Apr 1993to Jun 2015
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The female patient has a histological diagnosis of invasive carcinoma of the breast, and no evidence of metastatic disease.
- Has had a lumpectomy (including segmental resection and partial mastectomy), that is, surgical excision of the tumour with a rim of normal tissue.
- Patient has not had an axillary dissection, OR for patients who have had an axillary dissection, all nodes are negative for metastatic disease.
Who cannot join
- Tumour greater than 5 cm in greatest diameter on pathological examination.
- The presence of invasive or intraductal (noninvasive) breast cancer involving the surgical margins.
- Clinical evidence prior to surgery of infiltration of the skin of the involved breast such as edema, ulceration, or fixation of the tumour to underlying muscle, or inflammatory breast cancer.
- Bilateral malignancy of the breast (synchronous or metachronous).
- More than one primary invasive tumour in the same breast.
- Previous surgery for breast cancer.
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- Pathological status of axilla is unknown.
- Status for adjuvant systemic therapy not determined.
- For patients not treated with adjuvant chemotherapy: unable to commence radiation therapy within 16 weeks of last surgical procedure on the breast.
- For patients treated with adjuvant chemotherapy: unable to commence radiation therapy within 8 weeks of the last dose of chemotherapy.
- Serious nonmalignant disease (eg. cardiovascular, renal, etc.) which would preclude surgical or radiation treatment.
- Currently pregnant or lactating.
- Breast deemed too large to permit satisfactory radiation (ie. separation > 25 cm).
- Previous concomitant malignancies of any type except squamous, or basal cell carcinomas of the skin, or carcinoma \fIin situ\fR of the cervix which have been effectively treated.
- Geographic inaccessibility for follow-up.
- Psychiatric or addictive disorders which preclude obtaining informed consent or adherence to the protocol.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Canada11 sites
Regional Cancer Program of the Sudbury Regional Hospital
Greater Sudbury, Ontario, P3E 5J1
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, K7L 5P9
London Regional Cancer Centre
London, Ontario, N6A 4L6
Montreal General Hospital
Montreal, Quebec, H3G 1A4
Ottawa Hospital-Integrated Cancer Program
Ottawa, Ontario, K1H 1C4
Niagara Health System
St. Catharines, Ontario, L2R 5K3
Regional Cancer Care - Thunder Bay HSC
Thunder Bay, Ontario, P7B 6V4
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
The Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3
About this study
Official title: A Randomized Trial of Hypofractionated Radiotherapy Post-Lumpectomy in Women With Node Negative Breast Cancer
To determine if hypofractionated radiotherapy to the whole breast (4,250 cGy/16 fractions over 22 days) is equally effective to standard fractionated radiotherapy (5,000 cGy/25 fractions over 35 days) in women with node negative breast cancer who have undergone lumpectomy.
The primary outcome is local breast recurrence and secondary outcomes include morbidity and cost effectiveness.
- Conditions
- Breast Cancer
- Being tested
- Conventional whole breast radiation schedule, Hypofractionated whole breast radiation schedule
- Keywords
- Breast Cancer, Hypofractionated Radiotherapy, Lumpectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional whole breast radiation scheduleRadiation
Hypofractionated whole breast radiation scheduleRadiation
| Study group | Role | What they receive |
|---|---|---|
| Hypofractionated whole breast radiation | Experimental | Subjects treated with 4250 cGY in 16 fractions Receives: Radiation: Hypofractionated whole breast radiation schedule |
| Conventional whole breast radiation | Active comparator | Subjects treated with 5000 cGY in 25 fractions Receives: Radiation: Conventional whole breast radiation schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local breast recurrence
Measured: Indefinitely
Secondary outcomes (2)
Morbidity
Measured: Indefinitely
Cost effectiveness
Measured: Indefinitely
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startApr 1993
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tim Whelan, MD, Study chair, Juravinski Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156052
- Sponsor's protocol ID
- OCOG-1993-hypo
- Status last verified
- Jun 2015
- First submitted
- 8 Sep 2005
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Whelan T, MacKenzie R, Julian J, Levine M, Shelley W, Grimard L, Lada B, Lukka H, Perera F, Fyles A, Laukkanen E, Gulavita S, Benk V, Szechtman B. Randomized trial of breast irradiation schedules after lumpectomy for women with lymph node-negative breast cancer. J Natl Cancer Inst. 2002 Aug 7;94(15):1143-50. doi: 10.1093/jnci/94.15.1143.
PubMed 12165639Whelan TJ, Pignol JP, Levine MN, Julian JA, MacKenzie R, Parpia S, Shelley W, Grimard L, Bowen J, Lukka H, Perera F, Fyles A, Schneider K, Gulavita S, Freeman C. Long-term results of hypofractionated radiation therapy for breast cancer. N Engl J Med. 2010 Feb 11;362(6):513-20. doi: 10.1056/NEJMoa0906260.
PubMed 20147717
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Hypofractionated Radiotherapy Post-Lumpectomy in Women With Node Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT00156052
- Acronym / sponsor ID
- OCOG-1993-hypo
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Hypofractionated Radiotherapy, Lumpectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,234 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Study start
- Apr 1993
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 12 Sep 2005 (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.
To determine if hypofractionated radiotherapy to the whole breast (4,250 cGy/16 fractions over 22 days) is equally effective to standard fractionated radiotherapy (5,000 cGy/25 fractions over 35 days) in women with node negative breast cancer who have undergone lumpectomy.
The primary outcome is local breast recurrence and secondary outcomes include morbidity and cost effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypofractionated whole breast radiation | Experimental | Radiation: Hypofractionated whole breast radiation scheduleSubjects treated with 4250 cGY in 16 fractions |
| Conventional whole breast radiation | Active comparator | Radiation: Conventional whole breast radiation scheduleSubjects treated with 5000 cGY in 25 fractions |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- The female patient has a histological diagnosis of invasive carcinoma of the breast, and no evidence of metastatic disease.
- Has had a lumpectomy (including segmental resection and partial mastectomy), that is, surgical excision of the tumour with a rim of normal tissue.
- Patient has not had an axillary dissection, OR for patients who have had an axillary dissection, all nodes are negative for metastatic disease.
Key exclusion criteria (16 listed)
- Tumour greater than 5 cm in greatest diameter on pathological examination.
- The presence of invasive or intraductal (noninvasive) breast cancer involving the surgical margins.
- Clinical evidence prior to surgery of infiltration of the skin of the involved breast such as edema, ulceration, or fixation of the tumour to underlying muscle, or inflammatory breast cancer.
- Bilateral malignancy of the breast (synchronous or metachronous).
- More than one primary invasive tumour in the same breast.
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 |
|---|---|---|
| Conventional whole breast radiation schedule | Radiation | Conventional whole breast radiation |
| Hypofractionated whole breast radiation schedule | Radiation | Hypofractionated whole breast radiation |
Primary outcome
Local breast recurrence
Time frame: Indefinitely
2 secondary outcomes
Morbidity
Time frame: Indefinitely
Cost effectiveness
Time frame: Indefinitely
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 8 Jun 2015.
- Results publication: PubMed 12165639Whelan T, MacKenzie R, Julian J, Levine M, Shelley W, Grimard L, Lada B, Lukka H, Perera F, Fyles A, Laukkanen E, Gulavita S, Benk V, Szechtman B. Randomized trial of breast irradiation schedules after lumpectomy for women with lymph node-negative breast cancer. J Natl Cancer Inst. 2002 Aug 7;94(15):1143-50. doi: 10.1093/jnci/94.15.1143.
- Results publication: PubMed 20147717Whelan TJ, Pignol JP, Levine MN, Julian JA, MacKenzie R, Parpia S, Shelley W, Grimard L, Bowen J, Lukka H, Perera F, Fyles A, Schneider K, Gulavita S, Freeman C. Long-term results of hypofractionated radiation therapy for breast cancer. N Engl J Med. 2010 Feb 11;362(6):513-20. doi: 10.1056/NEJMoa0906260.
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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.
Tim Whelan, MD study chair
Juravinski Cancer Centre
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional whole breast radiation schedule and Hypofractionated whole breast radiation schedule in people with Breast Cancer, run by Ontario Clinical Oncology Group (OCOG) at 11 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?
The sponsor lists 3 inclusion and 16 exclusion criteria. 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 8 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 breast recurrence (time frame: Indefinitely). 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 NCT00156052, which also lists 2 linked publications.
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 8 Jun 2015.