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Active, not recruiting

NCT Number: NCT05775757

SMC Radiation Oncology Breast Cancer Cohort Study

The goal of this observational study is to learn about toxicities and cosmetic outcomes in breast cancer patients treated with hypofractionated radiotherapy.

The main question it aims to answer are:

* Changes in breast skin * Factors related to breast skin changes * Patient-reported outcomes * Cosmetic outcomes

Participants will be assessed by multi-dimensional methods before and after radiotherapy:

* Photographs * Fibrometer * Questionnaires (BREAST-Q) * CTCAE version 4.03 evaluated by treating physicians

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Radiotherapy Side Effect Radiation Injuries Wounds and Injuries

Age range

18 year–85 year

Sex eligibility

Female

Study type

Observational

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Breast cancer treated with curative surgery

Exclusion criteria

  • History of thoracic radiation therapy

Treatment and study plan

Hypofractionated Radiation Therapy

Radiation

Both 3-week and 1-week hypofractioanted radiation therapy are allowed. (simultaneous or sequential tumor bed boost is allowed.) A 3-week regimen includes 42.4 Gy in 16 fractions. A 1-week regimen includes 26 Gy in 5 fractions or 28.5 Gy in 3 fractions, 30 Gy in 5 fractions.

Primary outcomes

  1. Change of cosmesis from baseline

    Time frame: After 2-3 weeks after the start of radiation therapy (During radiation therapy)

    Evaluated by two blinded independent physicians based on photographs

  2. Change of cosmesis from baseline

    Time frame: 2-3 weeks after the completion of radiation therapy

    Evaluated by two blinded independent physicians based on photographs

  3. Change of cosmesis from baseline

    Time frame: 6 months after radiation therapy

    Evaluated by two blinded independent physicians based on photographs

  4. Change of cosmesis from baseline

    Time frame: 1 year after radiation therapy

    Evaluated by two blinded independent physicians based on photographs

  5. Change of cosmesis from baseline

    Time frame: 2 year after radiation therapy

    Evaluated by two blinded independent physicians based on photographs

  6. Change of cosmesis from baseline

    Time frame: 5 year after radiation therapy

    Evaluated by two blinded independent physicians based on photographs

  7. Change of fibrosis from baseline

    Time frame: After 2-3 weeks after the start of radiation therapy (During radiation therapy)

    Evaluated using fibrometer measuring both breast

  8. Change of fibrosis from baseline

    Time frame: 2-3 weeks after the completion of radiation therapy

    Evaluated using fibrometer measuring both breast

  9. Change of fibrosis from baseline

    Time frame: 6 months after radiation therapy

    Evaluated using fibrometer measuring both breast

  10. Change of fibrosis from baseline

    Time frame: 1 year after radiation therapy

    Evaluated using fibrometer measuring both breast

  11. Change of fibrosis from baseline

    Time frame: 2 year after radiation therapy

    Evaluated using fibrometer measuring both breast

  12. Change of fibrosis from baseline

    Time frame: 5 year after radiation therapy

    Evaluated using fibrometer measuring both breast

  13. Change of patient-reported outcome from baseline

    Time frame: After 2-3 weeks after the start of radiation therapy (During radiation therapy)

    BREAST-Q questionnaire is used to evaluate patient-reported outcome.

  14. Change of patient-reported outcome from baseline

    Time frame: 2-3 weeks after the completion of radiation therapy

    BREAST-Q questionnaire is used to evaluate patient-reported outcome.

  15. Change of patient-reported outcome from baseline

    Time frame: 6 months after radiation therapy

    BREAST-Q questionnaire is used to evaluate patient-reported outcome.

  16. Change of patient-reported outcome from baseline

    Time frame: 1 year after radiation therapy

    BREAST-Q questionnaire is used to evaluate patient-reported outcome.

  17. Change of patient-reported outcome from baseline

    Time frame: 2 year after radiation therapy

    BREAST-Q questionnaire is used to evaluate patient-reported outcome.

  18. Change of patient-reported outcome from baseline

    Time frame: 5 year after radiation therapy

    BREAST-Q questionnaire is used to evaluate patient-reported outcome.

  19. Physician assessed toxicity

    Time frame: After 2-3 weeks after the start of radiation therapy

    CTCAE version 4.03 is used to evaluate physician-assessed toxicities.

  20. Physician assessed toxicity

    Time frame: 2-3 weeks after the completion of radiation therapy

    CTCAE version 4.03 is used to evaluate physician-assessed toxicities.

  21. Physician assessed toxicity

    Time frame: 6 months after radiation therapy

    CTCAE version 4.03 is used to evaluate physician-assessed toxicities.

  22. Physician assessed toxicity

    Time frame: 1 year after radiation therapy

    CTCAE version 4.03 is used to evaluate physician-assessed toxicities.

  23. Physician assessed toxicity

    Time frame: 2 year after radiation therapy

    CTCAE version 4.03 is used to evaluate physician-assessed toxicities.

  24. Physician assessed toxicity

    Time frame: 5 year after radiation therapy

    CTCAE version 4.03 is used to evaluate physician-assessed toxicities.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Registry for Analysis of Impact of Radiation Dose to Skin on Cosmetic Outcome and Patient-reported Outcomes in Patients With Breast Cancer Treated With Radiation Therapy

Acronym: RASCO

Important dates

Study start
2021
Primary completion
2030
Study completion
2030
First posted
Mar 20, 2023
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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