Ignite Creation Date:
2024-05-05 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 9:49 AM
Study NCT ID:
NCT00681993
Status:
COMPLETED
Last Update Posted:
2019-01-22
First Post:
2008-05-19
Brief Title:
Trial of Partial Breast Irradiation With Various Concurrent Chemotherapy Regimens
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
A Feasibility Trial of Partial Breast Irradiation With Various Concurrent Chemotherapy Regimens PBIC
Status:
COMPLETED
Status Verified Date:
2019-01
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:
PBIC
Brief Summary:
Breast conserving therapy BCT which consists of wide local excision of the tumor followed by 6 weeks of whole breast irradiation WBI is integral to the management of breast cancer Evidence now suggests that WBI may not be necessary and treatment to the involved area only partial breast irradiation PBI may suffice PBI can be achieved by interstitial or intracavitary brachytherapy intra-op or post op external beam radiation therapy The feasibility toxicity and efficacy of PBI are currently being studied in both the US and Europe Review of smaller studies suggests that PBI will prove to be comparable to WBI Chemotherapy combined with radiation has been shown to increase local control in BCT when compared to radiation alone However there is little data on how sequencing or timing of these therapies with respect to one another affect outcome As a result there is no consensus about the optimal combination There are real and potential benefits to concurrent chemo-radiation therapy Concurrent therapy 1 allows both treatments to start closer to surgery theoretically maximizing the benefits of each modality 2 shortens the overall treatment program and 3 may also improve local control via chemo-sensitization of residual cancer cells However concurrent chemotherapy and WBI have been associated with prohibitive skin toxicity Since less breast tissue is treated with PBI this skin toxicity may no longer be prohibitive We have shown in J0381 that PBI and concurrent dose dense AC is safe As a follow-up we propose a phase III trial addressing the toxicity and efficacy associated with PBI delivered concurrently with various chemotherapy regimens
Detailed Description:
1 Partial Breast Irradiation with concurrent chemotherapy various regimens Subjects will receive Segmental Mastectomy Lumpectomy
2 Medical Oncology Evaluation
3 ConsentRegistration Pre-RT evaluation
4 SimulationTreatment Planning
5 Chemo-Radiation Therapy
ddAC Std AC TAC TC TCH or TH Concurrent with PBI - 270 cGy per fraction for 15 fractions RT may start up to 7days prior to C1D1 but no later than 7 days after C1D1 - 7 days of C1D1 radiation may start
6 Further chemotherapy hormonal therapy or biologic therapy at the medical oncologists discretion
7 FU Schedule
2 Medical Oncology Evaluation
3 ConsentRegistration Pre-RT evaluation
4 SimulationTreatment Planning
5 Chemo-Radiation Therapy
ddAC Std AC TAC TC TCH or TH Concurrent with PBI - 270 cGy per fraction for 15 fractions RT may start up to 7days prior to C1D1 but no later than 7 days after C1D1 - 7 days of C1D1 radiation may start
6 Further chemotherapy hormonal therapy or biologic therapy at the medical oncologists discretion
7 FU Schedule
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 |
|---|---|---|---|
| IRB00063221 | OTHER | JHM IRB | None |