Radiotherapy With Hyperthermia in Recurrent and Radiation-Induced Sarcomas
关键词
抽象
描述
Due to the rarity of radiation-induced (RIS) or previously irradiated recurrent (PIRS) sarcomas, no guidelines nor randomized prospective clinical trials on this topic exist. Thus the management of RIS and PIR is challenging. The only curable modality in non-metastatic RIS/PIRS is radical resection with wide negative margins. The role of secondary radiotherapy in locally advanced RIS/PIRS is unclear, mostly due to the concerns about possible severe side effects after re-irradiation.
The addition of deep hyperthermia to irradiation and in the prolonged gap between the end of moderately hypofractionated radiotherapy (with or without integrated boost) and surgery may allow obtaining the long-term local control with the maintenance of a good treatment tolerance Hyperthermia is a method of increasing the temperature in the tumor to damage cancer cells with minimum injury to the normal cells. It should be combined with another treatment modality (radio- or chemotherapy) rather than used alone. Its efficacy was proven in clinical trials. Treatment tolerance is usually very good.
日期
| 最后验证: | 04/30/2020 |
| 首次提交: | 05/17/2020 |
| 提交的预估入学人数: | 05/17/2020 |
| 首次发布: | 05/20/2020 |
| 上次提交的更新: | 05/20/2020 |
| 最近更新发布: | 05/25/2020 |
| 实际学习开始日期: | 10/22/2019 |
| 预计主要完成日期: | 03/31/2022 |
| 预计完成日期: | 03/31/2023 |
状况或疾病
干预/治疗
Radiation: Hypofractionated radiotherapy
Other: Hyperthermia
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Radiotherapy with hyperthermia in resectable sarcomas 12x 3 Gy (4 fractions per week) + hyperthermia (6x) + surgery | |
| Experimental: Radiotherapy with hyperthermia in non-resectable sarcomas 12x 3 Gy with simultaneous integrated boost 3.5 Gy (4 fractions per week) + hyperthermia (6x) |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Able to provide informed consent - Eastern Cooperative Oncology Group performance status 0 - 2 - Age ≥18 years old - Histologically-proven diagnosis of radiation-induced or recurrent soft tissue sarcoma - Previous radiotherapy within the planned target volume Exclusion Criteria: - Histologic diagnosis of rhabdomyosarcoma (except spindle cell and pleomorphic subtype), osteogenic sarcoma, Ewing's sarcoma/PNET, aggressive fibromatosis - Contraindications to radiotherapy or hyperthermia - Predicted unacceptable high risk of reirradiation-related toxicity, in the Investigator's judgment - Unresectable metastases |
结果
主要结果指标
1. Ratio of late adverse events [18 months]
次要成果指标
1. Local control rate [18 months]
2. Progression-free survival [18 months]
3. Cancer-specific survival [18 months]
