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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
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This research study is being done to carefully evaluate the effect of giving radiation therapy after temporary breast reconstruction. The investigators want to see if this type of reconstruction combined with radiation will look better (once the final reconstruction has been completed) and will reduce the risk that the participant will develop complications that sometimes occur with other kinds of reconstruction procedures. The investigators also want to know if it is easier to give the radiation with this type of reconstruction than with other kinds of reconstruction procedures. The reconstruction procedure involves the temporary use of a tissue expander and an acellular dermal matrix (ADM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TE-ADM with PMRT | Experimental | Participants received immediate breast reconstruction using a sub-muscular tissue expander (TE) and acellular dermal matrix (ADM) sling placed during the same surgery. This was followed by post-mastectomy radiation therapy (PMRT) no sooner than a minimum of 6 weeks and optimally 6 months, if adjuvant chemotherapy was required. The prescribed chest-wall dose was 50 -50.4 gray (Gy) in 25-28 fractions given once daily over 5-7 weeks with a 0.5-centimeter (cm) bolus to the scar every other day. Permanent reconstruction was performed at least 5 months after completion of PMRT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| post-mastectomy radiation therapy (PMRT) | Radiation |
| ||
| tissue expander (TE) |
| Measure | Description | Time Frame |
|---|---|---|
| Success Rate | Success rate was defined as the percentage of participants experiencing all of the following: 1) completion of PMRT and placement of the permanent implant and/or flap reconstruction; 2) no major complications (infection requiring hospitalization, major revisions, early/severe capsular contracture, or pain requiring implant removal); and 3) a physician-reported 'excellent' or 'good' cosmetic result (not 'fair' or 'poor') at 2 years following PMRT (requiring a stable reconstruction with good symmetry and contour relative to the contralateral breast). | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Lung Dose-Volume | Lung dose-volumes were assessed as a percentage of the ipsilateral lung irradiated via dose-volume histograms. | Lung dose-volume was measured at the end of radiation therapy which was up to 11 weeks from enrollment in this study cohort. |
| Cosmetic Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia Wong, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Dana-Farber Cancer Institute |
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Participants enrolled from September 2009 through September 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | TE-ADM With PMRT | Participants received immediate breast reconstruction using a sub-muscular tissue expander (TE) and acellular dermal matrix (ADM) sling placed during the same surgery. This was followed by post-mastectomy radiation therapy (PMRT) no sooner than a minimum of 6 weeks and optimally 6 months, if adjuvant chemotherapy was required. The prescribed chest-wall dose was 50 -50.4 gray (Gy) in 25-28 fractions given once daily over 5-7 weeks with a 0.5-centimeter (cm) bolus to the scar every other day. Permanent reconstruction was performed at least 6 months after completion of PMRT. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tissue Expander and Acellular Dermal Matrix | immediate reconstruction with a TE and ADM followed by PMRT radiation: The prescribed chest-wall dose will be 50 - 50.4 Gy in 25-28 fractions, given once daily over 5-7 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Success Rate | Success rate was defined as the percentage of participants experiencing all of the following: 1) completion of PMRT and placement of the permanent implant and/or flap reconstruction; 2) no major complications (infection requiring hospitalization, major revisions, early/severe capsular contracture, or pain requiring implant removal); and 3) a physician-reported 'excellent' or 'good' cosmetic result (not 'fair' or 'poor') at 2 years following PMRT (requiring a stable reconstruction with good symmetry and contour relative to the contralateral breast). | The analysis population is comprised of the evaluable subset of participants with complete 2 year follow-up data. | Posted | Number | 95% Confidence Interval | percentage of participants | 2 years |
|
Specific adverse events (AEs) as listed were evaluated and reported on the follow-up and cosmetic evaluation case report form at 6-, 12-, 18- and 24 months post RT. AEs were graded according to 5 classifications: mild, mild-moderate, moderate, moderate-severe and severe. Serious AEs were defined as AEs with a classification of moderate-severe or severe and other AEs with a classification of mild, mild-moderate or moderate.
The analysis population excludes 1 participant lost-to follow-up who left the country immediately following PMRT.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TE-ADM With PMRT | Participants received immediate breast reconstruction using a sub-muscular tissue expander (TE) and acellular dermal matrix (ADM) sling placed during the same surgery. This was followed by post-mastectomy radiation therapy (PMRT) no sooner than a minimum of 6 weeks and optimally 6 months, if adjuvant chemotherapy was required. The prescribed chest-wall dose was 50 -50.4 gray (Gy) in 25-28 fractions given once daily over 5-7 weeks with a 0.5-centimeter (cm) bolus to the scar every other day. Permanent reconstruction was performed at least 6 months after completion of PMRT. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Delayed Healing Wound | Skin and subcutaneous tissue disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Delayed Healing | Skin and subcutaneous tissue disorders | Systematic Assessment |
The major limitation of this study was its small sample size and its single arm nature.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julia Wong, MD | Dana-Farber Cancer Institute | 617-632-3591 | JWONG@LROC.HARVARD.EDU |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015625 | Tissue Expansion Devices |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D013523 | Surgical Equipment |
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| Device |
|
| acellular dermal matrix (ADM) | Device |
|
Cosmesis was measured by means of strict photographic analysis using five views (frontal, right and left lateral, and right and left quarter views) and independent assessment of the results by a plastic surgeon or radiation oncologist who has not treated the patient. Cosmetic score was defined in 4 categories: Excellent = treated breast looks essentially the same as the opposite breast; Good = minimal but identifiable result of treatment; Fair = significant effects of radiation therapy noted; Poor = severe normal tissue sequelae. |
| 2 years |
| Baker Classification Peak Score | An independent assessment of contracture was conducted by a plastic surgeon or radiation oncologist who had not treated the participant. Photographic analysis incorporated five views (frontal, right and left lateral, and right and left quarter views). Baker classification was used to score the extent of contracture: Class IA-absolutely natural, cannot tell breast was reconstructed; Class IB-soft, but the implant is detectable by physical examination or inspection because of mastectomy; Class II-mildly firm reconstructed breast with an implant that may be visible and detectable by physical examination; Class III-moderately firm reconstructed breast with readily detectable implant, but the result may still be acceptable; or Class IV-severe capsular contracture with an unacceptable aesthetic outcome and/or significant patient symptoms requiring surgical intervention. | Assessed up to 2 years post PMRT |
| Baker Classification 2-Year Score | An independent assessment of contracture was conducted by a plastic surgeon or radiation oncologist who had not treated the participant. Photographic analysis incorporated five views (frontal, right and left lateral, and right and left quarter views). Baker classification was used to score the extent of contracture: Class IA-absolutely natural, cannot tell breast was reconstructed; Class IB-soft, but the implant is detectable by physical examination or inspection because of mastectomy; Class II-mildly firm reconstructed breast with an implant that may be visible and detectable by physical examination; Class III-moderately firm reconstructed breast with readily detectable implant, but the result may still be acceptable; or Class IV-severe capsular contracture with an unacceptable aesthetic outcome and/or significant patient symptoms requiring surgical intervention. | 2 Years |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Withdrawal by Subject |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Breast Cancer Laterality | Count of Participants | Participants |
|
| Mastectomy (unilateral, bilateral) | Count of Participants | Participants |
|
| Number of Lymph Nodes Excised | Per Table 1 [Clinical and Treatment Characteristiscs], 'Lymph nodes' is a baseline variable further broken down to : 'No. Lymph Nodes involved' and 'No. Lymph Nodes excised'. For further information please reference Atkins et al. Effects of Postmastectomy Radiation Therapy on Immediate Tissue Expander and Acellular Dermal Matrix Reconstruction: Results of a Prospective Clinical Trial. | Median | Full Range | lymph nodes |
|
| Number of Lymph Nodes Involved | Per Table 1 [Clinical and Treatment Characteristiscs], 'Lymph nodes' is a baseline variable further broken down to : 'No. Lymph Nodes involved' and 'No. Lymph Nodes excised'. For further information please reference Atkins et al. Effects of Postmastectomy Radiation Therapy on Immediate Tissue Expander and Acellular Dermal Matrix Reconstruction: Results of a Prospective Clinical Trial. | Median | Full Range | lymph nodes |
|
|
|
| Secondary | Lung Dose-Volume | Lung dose-volumes were assessed as a percentage of the ipsilateral lung irradiated via dose-volume histograms. | The analysis population is comprised of all enrolled participants. | Posted | Median | Full Range | percentage radiation dose to lung | Lung dose-volume was measured at the end of radiation therapy which was up to 11 weeks from enrollment in this study cohort. |
|
|
|
| Secondary | Cosmetic Score | Cosmesis was measured by means of strict photographic analysis using five views (frontal, right and left lateral, and right and left quarter views) and independent assessment of the results by a plastic surgeon or radiation oncologist who has not treated the patient. Cosmetic score was defined in 4 categories: Excellent = treated breast looks essentially the same as the opposite breast; Good = minimal but identifiable result of treatment; Fair = significant effects of radiation therapy noted; Poor = severe normal tissue sequelae. | The analysis population is comprised of the evaluable subset of participants with complete 2 year follow-up data. | Posted | Count of Participants | Participants | 2 years |
|
|
|
| Secondary | Baker Classification Peak Score | An independent assessment of contracture was conducted by a plastic surgeon or radiation oncologist who had not treated the participant. Photographic analysis incorporated five views (frontal, right and left lateral, and right and left quarter views). Baker classification was used to score the extent of contracture: Class IA-absolutely natural, cannot tell breast was reconstructed; Class IB-soft, but the implant is detectable by physical examination or inspection because of mastectomy; Class II-mildly firm reconstructed breast with an implant that may be visible and detectable by physical examination; Class III-moderately firm reconstructed breast with readily detectable implant, but the result may still be acceptable; or Class IV-severe capsular contracture with an unacceptable aesthetic outcome and/or significant patient symptoms requiring surgical intervention. | The analysis population excludes 1 participant lost-to follow-up who left the country immediately following PMRT. | Posted | Count of Participants | Participants | Assessed up to 2 years post PMRT |
|
|
|
| Secondary | Baker Classification 2-Year Score | An independent assessment of contracture was conducted by a plastic surgeon or radiation oncologist who had not treated the participant. Photographic analysis incorporated five views (frontal, right and left lateral, and right and left quarter views). Baker classification was used to score the extent of contracture: Class IA-absolutely natural, cannot tell breast was reconstructed; Class IB-soft, but the implant is detectable by physical examination or inspection because of mastectomy; Class II-mildly firm reconstructed breast with an implant that may be visible and detectable by physical examination; Class III-moderately firm reconstructed breast with readily detectable implant, but the result may still be acceptable; or Class IV-severe capsular contracture with an unacceptable aesthetic outcome and/or significant patient symptoms requiring surgical intervention. | The analysis population is comprised of the evaluable subset of participants with complete 2 year follow-up data. | Posted | Count of Participants | Participants | 2 Years |
|
|
|
| 1 |
| 31 |
| 4 |
| 31 |
| 30 |
| 31 |
| Infection | Infections and infestations | Systematic Assessment |
|
| Deflation | Reproductive system and breast disorders | Systematic Assessment |
|
| Asymmetry | Reproductive system and breast disorders | Systematic Assessment |
|
| Skin Ischemia | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Chronic Drainage | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pain/costochondritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Asymmetry | Reproductive system and breast disorders | Systematic Assessment |
|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Deflation | Reproductive system and breast disorders | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| Title | Measurements |
|---|
|
| Poor |
|
| III |
|
| IV |
|
| III |
|
| IV |
|