CTSU CCCWF 97609 - "Impact of Genomics and Exposures on Disparities in Breast Cancer Radiosensitivity"

NOTES: 

1) Effective April 25, 2012 - Non-hispanic, white enrollment has met its accrual goal and this arm of the study has closed.  All other arms are still open.

2) CTSU sites are exempt from photograph requirement.

3) Register w/i 5 days of lab sample collection & other baseline procedures.  RT must begin /wi 4 wks post-regist.

Treatment Plan    (Supplied Drug:  N/A)

BASELINE LABS & QUESTIONNAIRES

Baseline Breast Cancer Risk Study Questionnaire

FACT-B

Modified Skindex-16

B-39 QOL Questionnaire

Blood & Urine samples

ONS Criteria for Acute Radiation-Induced Skin Reaction

Data Submission Checklist

Flow Sheet / Addenda

LAST DAY OF RT

Follow-up Breast Cancer Risk Study Questionnaire

FACT-B

Modified Skindex-16

B-39 QOL Questionnaire

Blood & Urine samples

ONS Criteria for Acute Radiation-Induced Skin Reaction

Breast/Chest Wall RT Completion Form

Data Submission Checklist

Flow Sheet / Addenda

1 MO POST-RT

FACT-B

Modified Skindex-16

B-39 QOL Questionnaire

Follow-up Breast Cancer Risk Study Questionnaire

ONS Criteria for Acute Radiation-Induced Skin Reaction

Data Submission Checklist

Flow Sheet / Addenda

2 MOS POST-RT

ONS Criteria for Acute Radiation-Induced Skin Reaction

Data Submission Checklist

Flow Sheet / Addenda

6 MOS & 12 MOS POST-RT

FACT-B

Modified Skindex-16

B-39 QOL Questionnaire & Functioning Metric

Follow-up Breast Cancer Risk Study Questionnaire

RTOG SOMA Criteria for RT-Induced Breast/Chest Wall Late Skin Toxicity

Data Submission Checklist

Flow Sheet / Addenda

Eligibility

• Females, newly diagnosed w/breast carcinoma Stgs 0-IIIA (including DCIS).

• Post-lumpectomy, - quadrantectomy, or -mastectomy.

• Plan to receive adjuv RT to whole breast or chest wall +/- regional lymph nodes.

• Total dose >40Gy.

• Dose per fx >1.8 (2D, 3D conformal, or IMRT allowed).  No skin sparing IMRT pts.  2.7Gy/fx daily to whole breast is suggested for hypofractionated regimens.

• Concurrent & sequential boosts are allowed for standard & hypofractionated regimens.

• Adjuv hormonal therapy allowed prior to, during, &/or after RT at med oncologist's discretion.

• Age >18.

• No prior RT to involved breast or chest wall.

• No concurrent chemo.  May receive chemo prior to RT or following RT at treating physician's discretion.

• No prior breast reconstruction following mastectomy (tissue expanders & implants are not allowed).

• No planned partial breast RT.

• No prior MammoSite® or other form of brachytherapy.

• Must submit blood/urine specimens to Wake Forest via overnight delivery.

• Must understand English or be able to complete forms w/assistance.

• No concurrent enrollment in a protocol involving tx of the skin.

• PRE-STUDY REQUIREMENTS:

  • Ht, wt

  • Baseline Breast Cancer Study Risk Questionnaire

  • Skindex-16

  • B-39 QOL (either for Lumpectomy Intact Breast or Mastectomy Chest Wall)

  • Urine samples*

  • Blood samples*

  • ONS Acute Skin Reaction**

  • FACT-B**

  • Data Submission Checklist / Flow Sheet / Addedna**

  *       Contact KCCOP for kit.  Obtain prior to start of RT.  Collect Mon-Thurs only & ship to Wake Forest same day as collected via overnight delivery.  Process per protocol.  Ship urine frozen on dry ice.  Ship whole blood at room temperature (two 8mL blue & black-top CPT vacutainer tubes).

  **    See protocol Section 7.9 for specific forms to be completed by research staff and patient.

• Signed informed consent.