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NCT00681993 · ClinicalTrials.gov registry record · NA
Trial of Partial Breast Irradiation With Various Concurrent Chemotherapy Regimens
A NA study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- NA
- Development phase
- 35
- Enrollment target
NCT00681993 is a NA study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 35 participants.
The verdict
NCT00681993, a NA study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
Study 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 U.S. 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 I/II trial addressing the toxicity and efficacy associated with PBI delivered concurrently with various chemotherapy regimens.
Interventions
- OTHER Standard Dose Dense Doxorubucin and Cyclophosphamide
- OTHER Standard Doxorubucin and Cyclophosphamide
- OTHER Standard Docetaxel, Carboplatin, and Herceptin
- OTHER Standard Docetaxel, Doxorubucin and Cyclophosphamide
- OTHER Standard Docetaxel and Cyclophosphamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2008-04 |
| Est. Completion | 2016-03-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00681993
The ClinicalTrials.gov registry entry for NCT00681993 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Standard Dose Dense Doxorubucin and Cyclophosphamide is the first listed.
NCT00681993 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00681993 about?
NCT00681993 is a clinical study titled "Trial of Partial Breast Irradiation With Various Concurrent Chemotherapy Regimens". 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 irr...
What is the current status of trial NCT00681993?
This trial is currently completed. It is a NA study. The enrollment target is 35 participants. The study started on 2008-04. Estimated completion is 2016-03-04.
What interventions are being tested in trial NCT00681993?
The interventions under investigation include: Standard Dose Dense Doxorubucin and Cyclophosphamide (OTHER), Standard Doxorubucin and Cyclophosphamide (OTHER), Standard Docetaxel, Carboplatin, and Herceptin (OTHER), Standard Docetaxel, Doxorubucin and Cyclophosphamide (OTHER), Standard Docetaxel and Cyclophosphamide (OTHER).
Who is sponsoring clinical trial NCT00681993?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
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