RAPID: Randomized Trial of Accelerated Partial Breast Irradiation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Canadian Breast Cancer Research Alliance
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT00282035
First received: January 23, 2006
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Radiation: 3D-CRT APBI
Radiation: WBI
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-centre Randomized Trial to Determine if Accelerated Partial Breast Irradiation, 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

Resource links provided by NLM:


Further study details as provided by Ontario Clinical Oncology Group (OCOG):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adverse cosmetic outcome [ Time Frame: evaluated at 1, 3, 5, 7 and 10 years ] [ Designated as safety issue: No ]
  • disease free survival [ Time Frame: ongoing throughout study ] [ Designated as safety issue: No ]
  • event free survival [ Time Frame: ongoing throughout study ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: ongoing throughout study ] [ Designated as safety issue: No ]
  • radiation toxicity [ Time Frame: ongoing throughout study ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: ongoing throughout study ] [ Designated as safety issue: No ]
  • cost effectiveness [ Time Frame: end of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 2128
Study Start Date: January 2006
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Accelerated partial breast irradiation utilizing 3D-CRT
Radiation: 3D-CRT APBI
Accelerated partial breast irradiation utilizing 3D-CRT
Active Comparator: 2
Whole breast irradiation
Radiation: WBI
Whole 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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00282035

  Show 33 Study Locations
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Canadian Institutes of Health Research (CIHR)
Canadian Breast Cancer Research Alliance
Investigators
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)
  More Information

No publications provided

Responsible Party: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT00282035     History of Changes
Other Study ID Numbers: OCOG-2005-RAPID, CIHR Grant Number: MCT-78567
Study First Received: January 23, 2006
Last Updated: May 7, 2013
Health Authority: Canada: Health Canada

Keywords provided by Ontario Clinical Oncology Group (OCOG):
breast cancer
breast tumour
DCIS
female
breast conserving surgery
irradiation
whole breast irradiation
3D CRT accelerated partial breast irradiation
cosmetic outcome
quality of life

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma, Intraductal, Noninfiltrating
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on April 15, 2014