Trial Outcomes & Findings for Partial Breast Irradiation Using Accelerated Intensity Modulated Radiotherapy (NCT NCT00581529)
NCT ID: NCT00581529
Last Updated: 2017-10-31
Results Overview
The primary objective was to determine the rate of local control (the arrest of cancer growth at the site of origin) of cancer in the treated breast at 5 years following breast-conserving surgery and partial breast radiotherapy using IMRT.
TERMINATED
PHASE2
34 participants
5 years
2017-10-31
Participant Flow
Participant milestones
| Measure |
Radiotherapy
Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Partial Breast Irradiation Using Accelerated Intensity Modulated Radiotherapy
Baseline characteristics by cohort
| Measure |
Radiotherapy
n=30 Participants
Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
|
|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Laterality
Left Breast
|
9 participants
n=5 Participants
|
|
Laterality
Right Breast
|
21 participants
n=5 Participants
|
|
Histology
DCIS
|
16 participants
n=5 Participants
|
|
Histology
IDC
|
14 participants
n=5 Participants
|
|
Chemotherapy
Yes
|
5 participants
n=5 Participants
|
|
Chemotherapy
No
|
25 participants
n=5 Participants
|
|
Endocrine Therapy
Yes
|
19 participants
n=5 Participants
|
|
Endocrine Therapy
No
|
11 participants
n=5 Participants
|
|
Re-excision
Yes
|
15 participants
n=5 Participants
|
|
Re-excision
No
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: 34 for patients were enrolled and treated.
The primary objective was to determine the rate of local control (the arrest of cancer growth at the site of origin) of cancer in the treated breast at 5 years following breast-conserving surgery and partial breast radiotherapy using IMRT.
Outcome measures
| Measure |
Radiotherapy
n=34 Participants
Accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
IMRT: Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
|
|---|---|
|
Rate of Local Control at 5 Years
|
97 percentage of participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: 34 for patients were enrolled and treated. 2 patients were excluded from all analysis due to fair baseline cosmesis. 2 additional patients underwent mastectomies and were therefore excluded from analysis (cosmesis could not be assessed at 5 years). 30 patients were analyzed.
The primary outcome was to determine the rate of acute cosmetic adverse events and late cosmetic adverse events at follow-up visits over 5 years. To determine the rate of adverse events, the percentage of participants experiencing no cosmetic AEs, at least 1 grade 1 toxicity, at least 1 grade 2 toxicity, and at least 1 grade 3 toxicity were calculated.
Outcome measures
| Measure |
Radiotherapy
n=30 Participants
Accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
IMRT: Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
|
|---|---|
|
Percentage of Participants That Experience Cosmetic Adverse Events (AEs)
Experiences no toxicities
|
23.3 percentage of participants
|
|
Percentage of Participants That Experience Cosmetic Adverse Events (AEs)
Experienced at least 1 grade 1 toxicity
|
40 percentage of participants
|
|
Percentage of Participants That Experience Cosmetic Adverse Events (AEs)
Experienced at least 1 grade 2 toxicity
|
30 percentage of participants
|
|
Percentage of Participants That Experience Cosmetic Adverse Events (AEs)
Experienced at least 1 grade 3 toxicity
|
6.7 percentage of participants
|
SECONDARY outcome
Timeframe: not specificPopulation: At the time the study was written, we planned to compare treatment methods. Over the course of the study, it was determined additional analysis was not needed due to the analysis and publication of this outcome by several other investigators.
Dosimetric and volumetric differences between treatment plans for partial breast irradiation and other treatment planning methods for the target (partial breast) and organs at risk (e.g. heart, ipsilateral lung, contralateral breast)a subset of 20.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 yearsPopulation: 34 for patients were enrolled and treated. 2 patients were excluded from all analysis due to fair baseline cosmesis.
One of the studies secondary outcomes was to evaluate the impact of short term accelerated partial breast radiation therapy on cosmetic results. To determine the association between dosimetric factors and cosmesis, the mean percentage of prescription dose received to WBV (Whole breast volume: corresponding region typically encompassed by traditional tangent fields) was compared among participants who developed fair/poor (F/P) cosmetic outcomes (unacceptable cosmesis) and participants who maintained excellent/good (E/G) cosmetic outcomes (acceptable cosmesis).
Outcome measures
| Measure |
Radiotherapy
n=32 Participants
Accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
IMRT: Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
|
|---|---|
|
Mean Percentage of Reference Volume Receiving 19.25 Gy and 38.5Gy for Patients With Acceptable and Unacceptable Cosmesis
Mean % receiving 19.25, Acceptable Cosmesis
|
34.6 Percentage of reference volume
Interval 16.6 to 49.2
|
|
Mean Percentage of Reference Volume Receiving 19.25 Gy and 38.5Gy for Patients With Acceptable and Unacceptable Cosmesis
Mean % receiving 19.25, Unacceptable Cosmesis
|
46.1 Percentage of reference volume
Interval 31.3 to 64.5
|
|
Mean Percentage of Reference Volume Receiving 19.25 Gy and 38.5Gy for Patients With Acceptable and Unacceptable Cosmesis
Mean % receiving 38.5, Acceptable Cosmesis
|
15.5 Percentage of reference volume
Interval 6.8 to 25.4
|
|
Mean Percentage of Reference Volume Receiving 19.25 Gy and 38.5Gy for Patients With Acceptable and Unacceptable Cosmesis
Mean % receiving 38.5, Unacceptable Cosmesis
|
23.0 Percentage of reference volume
Interval 14.0 to 29.5
|
Adverse Events
Radiotherapy
Serious adverse events
| Measure |
Radiotherapy
n=34 participants at risk
Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
|
|---|---|
|
General disorders
Fever with Neutropenia
|
5.9%
2/34
|
|
Nervous system disorders
Headache
|
2.9%
1/34
|
|
General disorders
Fever
|
2.9%
1/34
|
|
Reproductive system and breast disorders
Breast Volume/Hypoplasia
|
2.9%
1/34
|
|
Gastrointestinal disorders
Gastrointestinal Bleeding
|
2.9%
1/34
|
|
Vascular disorders
Telangiectasia
|
2.9%
1/34
|
|
Cardiac disorders
Chest Pain
|
2.9%
1/34
|
|
Gastrointestinal disorders
Diverticulitis
|
2.9%
1/34
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukemia
|
2.9%
1/34
|
|
Renal and urinary disorders
Kidney Stones
|
2.9%
1/34
|
|
Cardiac disorders
Aortic Aneurysm
|
2.9%
1/34
|
Other adverse events
| Measure |
Radiotherapy
n=34 participants at risk
Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
|
|---|---|
|
General disorders
Pain
|
23.5%
8/34
|
|
Reproductive system and breast disorders
Nipple/Areolar Deformity
|
76.5%
26/34
|
|
Reproductive system and breast disorders
Breast Hypoplasia
|
88.2%
30/34
|
|
Reproductive system and breast disorders
Breast Induration Fibrosis
|
73.5%
25/34
|
|
Reproductive system and breast disorders
Telangeictasia
|
20.6%
7/34
|
|
General disorders
Edema-Limb
|
5.9%
2/34
|
|
General disorders
Fatigue
|
50.0%
17/34
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
58.8%
20/34
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
32.4%
11/34
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.5%
8/34
|
|
Skin and subcutaneous tissue disorders
Burn
|
5.9%
2/34
|
|
Skin and subcutaneous tissue disorders
Fibrosis/Deep Tissue
|
8.8%
3/34
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
8.8%
3/34
|
|
Skin and subcutaneous tissue disorders
Pruitis/Itching
|
11.8%
4/34
|
|
Metabolism and nutrition disorders
Anorexia
|
2.9%
1/34
|
|
Gastrointestinal disorders
Nausea
|
2.9%
1/34
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.9%
1/34
|
|
Injury, poisoning and procedural complications
Wound Complication
|
2.9%
1/34
|
|
Skin and subcutaneous tissue disorders
Skin Atrophy
|
2.9%
1/34
|
|
Cardiac disorders
Congestive Heart Failure
|
2.9%
1/34
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy
|
2.9%
1/34
|
Additional Information
Dr. Lori Pierce, M.D.
University of Michigan Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place