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Trial record 1 of 1 for:    NCT00282035
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RAPID: Randomized Trial of Accelerated Partial Breast Irradiation

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ClinicalTrials.gov Identifier: NCT00282035
Recruitment Status : Completed
First Posted : January 25, 2006
Last Update Posted : July 13, 2018
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Canadian Breast Cancer Research Alliance
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)

Tracking Information
First Submitted Date  ICMJE January 23, 2006
First Posted Date  ICMJE January 25, 2006
Last Update Posted Date July 13, 2018
Study Start Date  ICMJE January 2006
Actual Primary Completion Date March 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
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 ]
ipsilateral breast tumour recurrence
Original Primary Outcome Measures  ICMJE
 (submitted: January 23, 2006)
ipsilateral breast tumour recurrence defined as recurrent invasive or in situ cancer in the ipsilateral breast including the axillary tail.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2018)
  • adverse cosmetic outcome [ Time Frame: evaluated at 1, 3, 5, 7 and 10 years ]
    adverse cosmetic outcome
  • disease free survival [ Time Frame: ongoing throughout study ]
    disease free survival
  • event free survival [ Time Frame: ongoing throughout study ]
    event free survival
  • overall survival [ Time Frame: ongoing throughout study ]
    overall survival
  • radiation toxicity [ Time Frame: ongoing throughout study ]
    radiation toxicity
  • quality of life based on questionnaire responses [ Time Frame: ongoing throughout study ]
    quality of life
  • cost effectiveness [ Time Frame: end of study ]
    cost effectiveness
Original Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2006)
  • adverse cosmetic outcome
  • disease free survival
  • event free survival
  • overall survival
  • radiation toxicity
  • quality of life
  • cost effectiveness
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RAPID: Randomized Trial of Accelerated Partial Breast Irradiation
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Radiation: APBI utilizing 3D-CRT radiation
    Accelerated partial breast irradiation utilizing 3D-CRT
  • Radiation: Whole breast irradiation
    Whole breast irradiation
Study Arms  ICMJE
  • Experimental: APBI utilizing 3D-CRT radiation
    Accelerated partial breast irradiation utilizing 3D-CRT
    Intervention: Radiation: APBI utilizing 3D-CRT radiation
  • Whole breast irradiation
    Whole breast irradiation
    Intervention: Radiation: Whole breast irradiation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 11, 2018)
2135
Original Enrollment  ICMJE
 (submitted: January 23, 2006)
2128
Actual Study Completion Date  ICMJE March 31, 2018
Actual Primary Completion Date March 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00282035
Other Study ID Numbers  ICMJE OCOG-2005-RAPID
CIHR Grant Number: MCT-78567 ( Other Grant/Funding Number: CIHR )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ontario Clinical Oncology Group (OCOG)
Study Sponsor  ICMJE Ontario Clinical Oncology Group (OCOG)
Collaborators  ICMJE
  • Canadian Institutes of Health Research (CIHR)
  • Canadian Breast Cancer Research Alliance
Investigators  ICMJE
Principal Investigator: Tim Whelan, MD Ontario Clinical Oncology Group / Juravinski Cancer Centre
Principal Investigator: Ivo Olivotto, MD British Columbia Cancer Agency - Vancouver Island Centre
Study Director: Mark Levine, MD Ontario Clinical Oncology Group (OCOG)
PRS Account Ontario Clinical Oncology Group (OCOG)
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP