Breast CancerPhase 3NCT00818051
Radiation Therapy in Treating Women Who Have Undergone Breast Conservation Surgery and Systemic Therapy for Early Breast Cancer
A Phase 3 study testing intensity-modulated radiation therapy in people with Breast Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy, such as intensity-modulated 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- intensity-modulated radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 840 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2008to not given
- Phase
- Phase 3
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed invasive breast cancer
- Resectable, unilateral disease
- T1-3, N0-1, M0 disease
- Has undergone prior breast conservation surgery with complete microscopic resection AND received appropriate systemic therapy for early breast cancer
- Requires a tumor bed boost plus whole breast radiotherapy as indicated by ≥ 1 of the following:
- Age 18-49 years
- Tumor size > 2.0 cm after primary surgery (maximum microscopic diameter of invasive component)
- Tumor of any size treated by primary medical therapy
- Grade III disease
- Minimum microscopic margin of noncancerous tissue < 5 mm (excluding deep margin if at deep fascia)
- Lymphovascular invasion
- Axillary node positive
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- No prior malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior mastectomy
- No concurrent chemotherapy except primary or sequential chemotherapy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden - Surrey
Sutton, England, SM2 5PT
John R. Yarnold, MD, FRCR, 44-20-8661-3388
About this study
Official title: Randomized Trial Testing Dose Escalated Intensity Modulated Radiotherapy for Women Treated by Breast Conservation Surgery and Appropriate Systemic Therapy for Early Breast Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy, such as intensity-modulated 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. It is not yet known which radiation therapy schedule is more effective in treating breast cancer.
PURPOSE: This randomized phase III trial is studying three different radiation therapy schedules to compare how well they work in treating women who have undergone breast conservation surgery and systemic therapy for early breast cancer.
Read the detailed description
OBJECTIVES:
- To test dose-escalated intensity-modulated radiotherapy after breast conservation surgery in women with early breast cancer who are at higher than average risk for local recurrence.
OUTLINE: This is a multicenter study. Patients are stratified according to center. Patients are randomized to 1 of 3 treatment arms.
- Arm I (control): Patients undergo sequential boost dose intensity-modulated radiotherapy (IMRT) 5 days a week for 4.6 weeks (23 fractions; 56 Gy).
- Arm II: Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 48 Gy).
- Arm III: Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 53 Gy).
Quality-of-life questionnaires are administered at baseline, 6 months, and at 1, 3, and 5 years. Photograph assessments of the breasts are taken at baseline and at 3 and 5 years. Blood samples are collected at baseline and periodically thereafter. Tissue samples are also collected from primary tumor, including new primary tumor in either breast, and recurrent tumor.
After completion of study treatment, patients are followed annually for 10 years.
- Conditions
- Breast Cancer
- Being tested
- intensity-modulated radiation therapy
- Keywords
- stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensity-modulated radiation therapyRadiation
Given as 48, 53, or 56 Gy
| Study group | Role | What they receive |
|---|---|---|
| Arm I (control) | Active comparator | Patients undergo sequential boost dose intensity-modulated radiotherapy (IMRT) 5 days a week for 4.6 weeks (23 fractions; 56 Gy). Receives: Radiation: intensity-modulated radiation therapy |
| Arm II | Experimental | Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 48 Gy). Receives: Radiation: intensity-modulated radiation therapy |
| Arm III | Experimental | Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 53 Gy). Receives: Radiation: intensity-modulated radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Palpable induration inside the boost volume of the irradiated breast
Secondary outcomes (6)
Other late adverse effects in normal tissue as measured by clinical and photographic assessments and patient self-assessments (quality-of-life questionnaires)
Local tumor control
Location of tumor relapse in breast
Contralateral primary tumors
Regional and distant metastases
Overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
- Study startAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Institute of Cancer Research, United KingdomThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Enrolment
- 840 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Investigators
- John R. Yarnold, MD, FRCR, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00818051
- Sponsor's protocol ID
- CDR0000629770
- Other IDs
- ICR-IMPORT-HIGH, ICR-CTSU/2007/10013, ISRCTN47437448, EU-20897
- Status last verified
- Jan 2009
- First submitted
- 6 Jan 2009
- Last updated
- 7 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Testing Dose Escalated Intensity Modulated Radiotherapy for Women Treated by Breast Conservation Surgery and Appropriate Systemic Therapy for Early Breast Cancer
- ClinicalTrials.gov ID
- NCT00818051
- Acronym / sponsor ID
- CDR0000629770
- Conditions
- Breast Cancer
- Keywords
- stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Study start
- Aug 2008
- First posted
- 7 Jan 2009 (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 uses high-energy x-rays to kill tumor cells. Specialized radiation therapy, such as intensity-modulated 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. It is not yet known which radiation therapy schedule is more effective in treating breast cancer.
PURPOSE: This randomized phase III trial is studying three different radiation therapy schedules to compare how well they work in treating women who have undergone breast conservation surgery and systemic therapy for early breast cancer.
Detailed description
OBJECTIVES:
- To test dose-escalated intensity-modulated radiotherapy after breast conservation surgery in women with early breast cancer who are at higher than average risk for local recurrence.
OUTLINE: This is a multicenter study. Patients are stratified according to center. Patients are randomized to 1 of 3 treatment arms.
- Arm I (control): Patients undergo sequential boost dose intensity-modulated radiotherapy (IMRT) 5 days a week for 4.6 weeks (23 fractions; 56 Gy).
- Arm II: Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 48 Gy).
- Arm III: Patients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 53 Gy).
Quality-of-life questionnaires are administered at baseline, 6 months, and at 1, 3, and 5 years. Photograph assessments of the breasts are taken at baseline and at 3 and 5 years. Blood samples are collected at baseline and periodically thereafter. Tissue samples are also collected from primary tumor, including new primary tumor in either breast, and recurrent tumor.
After completion of study treatment, patients are followed annually for 10 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (control) | Active comparator | Radiation: intensity-modulated radiation therapyPatients undergo sequential boost dose intensity-modulated radiotherapy (IMRT) 5 days a week for 4.6 weeks (23 fractions; 56 Gy). |
| Arm II | Experimental | Radiation: intensity-modulated radiation therapyPatients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 48 Gy). |
| Arm III | Experimental | Radiation: intensity-modulated radiation therapyPatients undergo concurrent boost dose IMRT 5 days a week for 3 weeks (15 fractions; 53 Gy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- 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 |
|---|---|---|
| intensity-modulated radiation therapyGiven as 48, 53, or 56 Gy | Radiation | Arm I (control), Arm II, Arm III |
Primary outcome
Palpable induration inside the boost volume of the irradiated breast
6 secondary outcomes
Other late adverse effects in normal tissue as measured by clinical and photographic assessments and patient self-assessments (quality-of-life questionnaires)
Local tumor control
Location of tumor relapse in breast
Contralateral primary tumors
Regional and distant metastases
Overall survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2011.
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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.
John R. Yarnold, MD, FRCR principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing intensity-modulated radiation therapy in people with Breast Cancer, run by Institute of Cancer Research, United Kingdom at 1 site in United Kingdom.
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: status not confirmed, as of the sponsor's last update on 7 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Palpable induration inside the boost volume of the irradiated breast. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2011.