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Breast CancerNCT00282035

RAPID: Randomized Trial of Accelerated Partial Breast Irradiation

A study testing APBI utilizing 3D-CRT radiation and Whole breast irradiation in people with Breast Cancer, run by Ontario Clinical Oncology Group (OCOG) at 33 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To determine if Accelerated Partial Breast Irradiation, using 3D CRT, is as effective as Whole Breast Irradiation following breast conserving surgery in women with an new histological diagnosis of ductal carcinoma in situ only or invasive breast cancer without evidence of metastatic disease. Read more about this study

Who is it for?
Ages 40 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
APBI utilizing 3D-CRT radiation and Whole breast irradiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,135 participants
Where
33 sitesin 3 countries
Study dates
Jan 2006to 31 Mar 2018
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 40 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1a. Female patient with a new histological diagnosis of DCIS only. OR
  • 1b. Female patient with a new histological diagnosis of invasive carcinoma of the breast and no evidence of metastatic disease.
  • 2. Treated by BCS with microscopically clear resection margins for invasive and non-invasive disease (or no residual disease on re- excision).
  • 3. Negative axillary node involvement including micrometastasis <= 0.2mm or positive cells only identified by IHC as determined either by: (i) sentinel node biopsy (ii) axillary node dissection or (iii) clinical exam for patients with DCIS only

Who cannot join

  • 1. Age < 40 years.
  • 2. A known deleterious mutation in BRCA 1 and/or BRCA 2.
  • 3. Tumour size > 3 cm in greatest diameter on pathological examination (including both the invasive and non-invasive component).
  • 4. Tumour histology limited to lobular carcinoma only.
  • 5. History of cancer:
  • Patients with another active malignancy or malignancy treated < 5 years prior to randomization are excluded.
Show all 20Show fewer
  • Patients with a prior diagnosis of invasive or non-invasive breast cancer in either breast are excluded regardless of disease free interval. Patients with concurrent invasive or non-invasive contralateral breast cancer are also excluded.
  • Patients with prior or concurrent basal cell or squamous cell skin cancers are eligible for the trial.
  • 6. More than one primary tumour in different quadrants of the same breast.
  • 7. Previous irradiation to the ipsilateral breast that would preclude whole breast irradiation.
  • 8. Presence of an ipsilateral breast implant or pacemaker.
  • 9. Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment.
  • 10. Estrogen receptor status (ER) not known.
  • 11. For patients not treated with adjuvant chemotherapy: unable to commence radiation therapy within 12 weeks of the last surgical procedure on the breast.
  • 12. For patients treated with adjuvant chemotherapy: unable to commence within 8 weeks of the last dose of chemotherapy.
  • 13. Currently pregnant or lactating.
  • 14. Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol.
  • 15. Geographic inaccessibility for follow-up.
  • 16. Inability to localize surgical cavity on CT (i.e., no evidence of surgical clips or seroma).
  • 17. Inability to adequately plan the patient for the experimental technique.

Trial locations and contacts

33 sites in 3 countries.

33 sites in 3 countries

Canada28 sites

  • BC Cancer Agency - Abbotsford Centre

    Abbotsford British Columbia, British Columbia, V2S 0C2

  • Brantford General Hospital

    Brantford, Ontario, N3R 1G9

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • CHUS - Hopital Fleurimont

    Fleurimont, Quebec, J1H 5N4

  • Northeastern Regional Cancer Centre

    Greater Sudbury, Ontario, P3E 5J1

  • QE II HSC - Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • British Columbia Cancer Agency - Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • Grand River Regional Cancer Centre

    Kitchener, Ontario, N2G 1G3

  • London Regional Cancer Centre

    London, Ontario, N6A 4L6

  • Credit Valley Hospital - Carlo Fidani Peel Regional Cancer Center

    Mississauga, Ontario, L5M 2N1

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • CHUM - Hospital Notre Dame

    Montreal, Quebec, H2L 4M1

  • McGill University - Montreal General Hospital

    Montreal, Quebec, H3G 1A4

  • McGill University - Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Durham Regional Cancer Centre - Lakeridge Health Corporation

    Oshawa, Ontario, L1G 2B9

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • Irving Greenberg Family Cancer Centre

    Ottawa, Ontario, K2H 8P4

  • CHUQ, L'Hotel Dieu de Quebec

    Québec, Quebec, G1R 2J6

  • Atlantic Health Sciences Corporation

    Saint John, New Brunswick, E2L 4L2

  • Niagara Health System

    St. Catharines, Ontario, L2R 5K3

  • British Columbia Cancer Agency - Fraser Valley Centre

    Surrey, British Columbia, V3V 1Z2

  • Princess Margaret Hospital - University Health Network

    Toronto, Ontario, M5G 2M9

  • British Columbia Cancer Agency - Vancouver Centre

    Vancouver, British Columbia, V5Z 4E6

  • British Columbia Cancer Agency - Vancouver Island Centre

    Vancouver, British Columbia, V8R 6V5

  • Windsor Regional Cancer centre

    Windsor, Ontario, N8W 2X3

  • Cancer Care Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Australia4 sites

  • Peter MacCallum Cancer Centre

    Bendigo, Victoria, 3550

  • Peter MacCallum Cancer Centre

    Box Hill, Victoria, 3128

  • Peter MacCallum Cancer Centre

    East Melbourne, Victoria, 3002

  • Peter MacCallum Cancer Centre - Monash Medical Centre Moorabbin

    Melbourne, Victoria, 3165

Other trials in Australia

New Zealand1 site

  • Auckland City Hospital

    Auckland, Auckland, 1023

Other trials in New Zealand

About this study

Official title: An RCT to Determine if APBI, Utilizing 3D CRT, is as Effective as Whole Breast Irradiation Following Breast Conserving Surgery in Women With Ductal Carcinoma in Situ or Invasive Breast Cancer With Negative Axillary Lymph Nodes

To determine if Accelerated Partial Breast Irradiation, using 3D CRT, is as effective as Whole Breast Irradiation following breast conserving surgery in women with an new histological diagnosis of ductal carcinoma in situ only or invasive breast cancer without evidence of metastatic disease. Effectiveness will be determined by the rate of ipsilateral breast tumour recurrence.

General objective is to improve the convenience and quality of life of female patients who receive breast irradiation.

Read the detailed description

Following breast conserving surgery or on completion of chemotherapy, patients will be stratified according to age, tumour histology, tumour size, adjuvant hormonal therapy and clinical centre. Patients will be allocated to receive either whole breast irradiation or 3D CRT accelerated partial breast irradiation.

Radiation therapy will be administered as soon as possible following the healing of the surgical incision (3-4 weeks) and within 12 weeks if the patient is not treated with chemotherapy. If the patient is treated with chemotherapy, radiation therapy will begin after 2 weeks and not beyond 8 weeks after the last dose of chemotherapy.

Patients treated with whole breast irradiation will receive a total dose of 42.5 Gy in 16 fractions, given on a daily basis, over a time period of 22 days. Patients with large breast size are permitted to receive a total dose of 50 Gy in 25 fractions, given on a daily basis, over a time period of 35 days. Boost irradiation is permitted in patients treated with whole breast irradiation. Boost irradiation of 10 Gy/4-5 fractions daily over a time period of 4-7 days is permitted for patients deemed at moderate to high risk of local recurrence as per local cancer centre guidelines.

Patients treated with 3D CRT accelerated partial breast irradiation will receive a total dose of 38.5 Gy in 10 fractions, delivered twice a day, over a time period of 5-8 days. Each daily dose must be separated by 6-8 hours.

Patients will be followed indefinitely and assessed formally at 6 and 12 months after the date of randomization and then on a yearly basis. Patients will be assessed for acute and late radiation toxicity, cardiac toxicity, recurrent disease, new primary cancer, cosmetic outcome, quality of life and overall survival.

Conditions
Breast Cancer
Being tested
APBI utilizing 3D-CRT radiation, Whole breast irradiation
Keywords
breast cancer, breast tumour, DCIS, female, breast conserving surgery, irradiation, whole breast irradiation, 3D CRT accelerated partial breast irradiation, cosmetic outcome, quality of life
Medical subject headings
Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • APBI utilizing 3D-CRT radiationRadiation

    Accelerated partial breast irradiation utilizing 3D-CRT

  • Whole breast irradiationRadiation

    Whole breast irradiation

Study groups in NCT00282035
Study groupRoleWhat they receive
APBI utilizing 3D-CRT radiationExperimentalAccelerated partial breast irradiation utilizing 3D-CRT
Receives: Radiation: APBI utilizing 3D-CRT radiation
Whole breast irradiationOtherWhole breast irradiation
Receives: Radiation: Whole breast irradiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ipsilateral breast tumour recurrence defined as recurrent invasive or in situ cancer in the ipsilateral breast including the axillary tail.

    ipsilateral breast tumour recurrence

    Measured: ongoing throughout study

Secondary outcomes (7)

  1. adverse cosmetic outcome

    adverse cosmetic outcome

    Measured: evaluated at 1, 3, 5, 7 and 10 years

  2. disease free survival

    disease free survival

    Measured: ongoing throughout study

  3. event free survival

    event free survival

    Measured: ongoing throughout study

  4. overall survival

    overall survival

    Measured: ongoing throughout study

  5. radiation toxicity

    radiation toxicity

    Measured: ongoing throughout study

  6. quality of life based on questionnaire responses

    quality of life

    Measured: ongoing throughout study

  7. cost effectiveness

    cost effectiveness

    Measured: end of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2006 (estimated)
  2. Study startJan 2006
  3. Primary completion31 Mar 2018
  4. Study completion31 Mar 2018

Resources

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
2,135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00282035
Sponsor's protocol ID
OCOG-2005-RAPID
Other IDs
CIHR Grant Number: MCT-78567
Status last verified
Jul 2018
First submitted
23 Jan 2006
Last updated
13 Jul 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Whelan TJ, Julian JA, Berrang TS, Kim DH, Germain I, Nichol AM, Akra M, Lavertu S, Germain F, Fyles A, Trotter T, Perera FE, Balkwill S, Chafe S, McGowan T, Muanza T, Beckham WA, Chua BH, Gu CS, Levine MN, Olivotto IA; RAPID Trial Investigators. External beam accelerated partial breast irradiation versus whole breast irradiation after breast conserving surgery in women with ductal carcinoma in situ and node-negative breast cancer (RAPID): a randomised controlled trial. Lancet. 2019 Dec 14;394(10215):2165-2172. doi: 10.1016/S0140-6736(19)32515-2. Epub 2019 Dec 5.

    PubMed 31813635

Questions about this trial

What is this clinical trial studying?

A study testing APBI utilizing 3D-CRT radiation and Whole breast irradiation in people with Breast Cancer, run by Ontario Clinical Oncology Group (OCOG) at 33 sites in 3 countries.

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 4 inclusion and 20 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 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Canada, Australia, New Zealand. 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?

ipsilateral breast tumour recurrence defined as recurrent invasive or in situ cancer in the ipsilateral breast including the axillary tail. (time frame: ongoing throughout study). 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 NCT00282035, 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 13 Jul 2018.

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Clinical Trial NCT00282035 | AzTrials