Trial of Tomotherapy in Breast Cancer
키워드
요약
기술
Prior to surgery: histological confirmation; medical imaging.
Localizing markers are placed in case of breast conserving surgery.
After surgery, patients are randomized to one of two treatment arms:
- Arm I: radiotherapy using tangential chest fields, and supraclavicular field in case of nodal involvement, according to our hospital's standard procedure (Voordeckers M et al, Radiother Oncol 2003;68:227 and 2004;70:225). Dose-fractionation: 50 Gy in 25 fractions over 5 weeks, 2 Gy/fraction. Additional boost 16 Gy in 8 fractions over 2 weeks if breast conserving surgery (verify marker/clip localization) and age <= 70 years.
- Arm II: radiotherapy using the Tomotherapy system. Target area (breast, thorax wall, nodal areas) delimited according to pre-operative imaging and pathological description. Dose-fractionation (adapted from Whelan T et al, JNCI 2002;94:1143): 42 Gy in 15 fractions over 3 weeks, 2.8 Gy/fraction. Simultaneous boost 0.6 Gy/fraction if breast conserving surgery.
Physics quality control is integrated during treatment in both arms.
Radiotherapy begins within 6 weeks after the last breast surgery. Concurrent or sequential adjuvant systemic treatments are allowed. In case of sequential adjuvant treatment with chemotherapy first, radiotherapy begins within 6 weeks after completion of the adjuvant chemotherapy.
Quality of life, arm mobility and edema, pulmonary and heart function are assessed prior to radiotherapy, at 1-3 months after completion of radiotherapy, then yearly.
날짜
| 마지막 확인: | 04/30/2017 |
| 처음 제출: | 04/10/2007 |
| 제출 된 예상 등록: | 04/10/2007 |
| 처음 게시 됨: | 04/11/2007 |
| 제출 된 마지막 업데이트: | 05/11/2017 |
| 마지막 업데이트 게시: | 05/15/2017 |
| 실제 연구 시작 날짜: | 04/30/2007 |
| 예상 기본 완료 날짜: | 07/31/2011 |
| 예상 연구 완료 날짜: | 11/30/2017 |
상태 또는 질병
개입 / 치료
Radiation: Conventional radiotherapy
Radiation: Tomotherapy
단계
팔 그룹
| 팔 | 개입 / 치료 |
|---|---|
| Active Comparator: Conventional radiotherapy Conventional Long schedule Radiotherapy Arm | Radiation: Conventional radiotherapy Radiation treatment delivered by conventional linear accelerator using matching fields |
| Experimental: Tomotherapy Short course schedule by tomotherapy | Radiation: Tomotherapy CT image guided intensity modulated radiation therapy delivered by the Tomotherapy HiArt system |
자격 기준
| 공부할 수있는 연령 | 18 Years 에 18 Years |
| 공부할 수있는 성별 | Female |
| 건강한 자원 봉사자를 받아들입니다 | 예 |
| 기준 | Inclusion Criteria: - Informed consent - Histologically proven breast carcinoma - Stage I or II (T1-3N0 or T1-2N1 M0, AJCC/TNM 6th edition) - Surgery with clear margins - Pre-operative medical imaging (at least CT, MRI, and/or PET-scan) Exclusion Criteria: - Prior breast or thoracic radiotherapy - Pregnancy or lactation - Fertile patients without effective contraception - Psychiatric or addictive disorders |
결과
1 차 결과 측정
1. Change from baseline in pulmonary function and heart function tests [From end of treatment up to 3 years after treatment]
2 차 결과 측정
1. Local-regional recurrences. [From end of treatment up to 15 years after treatment]
