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NCT00282035 · CITED IN SOURCE DOCUMENTS

RAPID: Randomized Trial of Accelerated Partial Breast Irradiation

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
NA
Status at capture
COMPLETED
Registry last update
2018-07-13

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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. * 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.
healthy Volunteers
false
minimum Age
40 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Accelerated partial breast irradiation utilizing 3D-CRT
    intervention Names
    1. Radiation: APBI utilizing 3D-CRT radiation
    label
    APBI utilizing 3D-CRT radiation
    type
    EXPERIMENTAL
  2. description
    Whole breast irradiation
    intervention Names
    1. Radiation: Whole breast irradiation
    label
    Whole breast irradiation
    type
    OTHER
interventions
  1. arm Group Labels
    1. APBI utilizing 3D-CRT radiation
    description
    Accelerated partial breast irradiation utilizing 3D-CRT
    name
    APBI utilizing 3D-CRT radiation
    type
    RADIATION
  2. arm Group Labels
    1. Whole breast irradiation
    description
    Whole breast irradiation
    name
    Whole breast irradiation
    type
    RADIATION
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
2135
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    ipsilateral breast tumour recurrence
    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
secondary Outcomes
  1. description
    adverse cosmetic outcome
    measure
    adverse cosmetic outcome
    time Frame
    evaluated at 1, 3, 5, 7 and 10 years
  2. description
    disease free survival
    measure
    disease free survival
    time Frame
    ongoing throughout study
  3. description
    event free survival
    measure
    event free survival
    time Frame
    ongoing throughout study
  4. description
    overall survival
    measure
    overall survival
    time Frame
    ongoing throughout study
  5. description
    radiation toxicity
    measure
    radiation toxicity
    time Frame
    ongoing throughout study
  6. description
    quality of life
    measure
    quality of life based on questionnaire responses
    time Frame
    ongoing throughout study
  7. description
    cost effectiveness
    measure
    cost effectiveness
    time Frame
    end of study
Full study description
brief 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. 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.
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.
Source references
references
  1. citation
    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.
    pmid
    31813635
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      occurrences
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        <p id="_3523" tabindex="-1">Evidence (partial breast irradiation):</p> <div class="pdq-content-list"><ol id="_3524"><li> The <a href="/clinicaltrials/NCT00282035">RAPID</a> trial (NCT00282035) randomly assigned 2,135 women aged 40 years or older with ductal carcinoma <em>in situ</em> or node-negative breast cancer treat
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      2. context exact
        Evidence (partial breast irradiation):</p> <div class="pdq-content-list"><ol id="_3524"><li> The <a href="/clinicaltrials/NCT00282035">RAPID</a> trial (NCT00282035) randomly assigned 2,135 women aged 40 years or older with ductal carcinoma <em>in situ</em> or node-negative breast cancer treated by breast-conserving surger
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      source retrieved at
      2026-09-09T23:21:35.419733+00:00
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      source string sha256
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      source title
      Breast Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: April 25, 2025
        datetime
        2025-04-25T12:00:00Z
        display
        April 25, 2025

    Preserved source evidence · Not medical advice