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Radiation Therapy After Surgery in Treating Women With Phyllodes Tumor of the Breast

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ClinicalTrials.gov Identifier: NCT00003404
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : January 21, 2019
Last Update Posted : January 21, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Richard J. Barth,Jr., Dartmouth-Hitchcock Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Intervention Radiation: Adjuvant Radiotherapy
Enrollment 46
Recruitment Details Patients were enrolled from a total of 30 different institutions. Half of the patients were treated at community-based treatment centers, and half were treated at academic medical centers.
Pre-assignment Details  
Arm/Group Title Adjuvant Radiotherapy
Hide Arm/Group Description Adjuvant radiation was started within 12 weeks of local excision or breast re-excision.
Period Title: Overall Study
Started 46
Completed 46
Not Completed 0
Arm/Group Title Adjuvant Radiotherapy
Hide Arm/Group Description Adjuvant radiation was started within 12 weeks of local excision or breast re-excision.
Overall Number of Baseline Participants 46
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 46 participants
49
(18 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Female
46
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 46 participants
46
1.Primary Outcome
Title Local Recurrence Rate
Hide Description Local recurrence rate of phyllodes tumors
Time Frame 36 months after initial excision
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Adjuvant Radiotherapy
Hide Arm/Group Description:

Adjuvant radiation was started within 12 weeks of local excision or breast re-excision.

Adjuvant Radiotherapy: Adjuvant radiation therapy

Overall Number of Participants Analyzed 46
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adjuvant Radiotherapy
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter rate of occurance
Estimated Value 0.35
Confidence Interval (2-Sided) 95%
0 to 8
Estimation Comments The local recurrence rate was estimated by dividing the number of recurrences by the total sample size. An exact 95% confidence interval (95% CI) for this rate was determined by binomial distribution.
2.Secondary Outcome
Title Survival Rate
Hide Description Survival will be tracked for 10 years after initial resection of first participant treated.
Time Frame Approximately 5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients received adjuvant radiotherapy as specified in the protocol. No patients were lost to follow-up. Duration of follow-up ranged from 12 to 129 months, with a median follow-up of 56 months and a mean follow-up of 60 months. Ninety percent of the patients were followed for at least 2 years.
Arm/Group Title Adjuvant Radiotherapy
Hide Arm/Group Description:
Adjuvant radiation after local excision or breast re-excision.
Overall Number of Participants Analyzed 46
Measure Type: Count of Participants
Unit of Measure: Participants
2
   4.3%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adjuvant Radiotherapy
Hide Arm/Group Description Adjuvant radiation after local excision or breast re-excision.
All-Cause Mortality
Adjuvant Radiotherapy
Affected / at Risk (%)
Total   2/46 (4.35%) 
Show Serious Adverse Events Hide Serious Adverse Events
Adjuvant Radiotherapy
Affected / at Risk (%)
Total   0/46 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adjuvant Radiotherapy
Affected / at Risk (%)
Total   0/46 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Richard J. Barth Jr., MD
Organization: Dartmouth Hitchcock Medical Center
Phone: (603) 650-9479
Responsible Party: Richard J. Barth,Jr., Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00003404     History of Changes
Other Study ID Numbers: D9801 CDR0000066410
P30CA023108 ( U.S. NIH Grant/Contract )
DMS-9801
DMS-12752
NCI-V98-1442
First Submitted: November 1, 1999
First Posted: January 27, 2003
Results First Submitted: October 3, 2018
Results First Posted: January 21, 2019
Last Update Posted: January 21, 2019