Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282035
Status:
COMPLETED
Last Update Posted:
2018-07-13
First Post:
2006-01-23
Brief Title:
RAPID Randomized Trial of Accelerated Partial Breast Irradiation
Sponsor:
Ontario Clinical Oncology Group OCOG
Organization:
Ontario Clinical Oncology Group OCOG
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 425 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 Gy4-5 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 385 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
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 425 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 Gy4-5 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 385 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CIHR Grant Number MCT-78567 | OTHER_GRANT | CIHR | None |