A prospective, single-arm, phase II clinical trial of intraoperative radiotherapy using a low-energy X-ray source for local advanced Laryngocarcinoma (ILAL): a study protocol
Abstract Background Laryngocarcinoma (LC), in most cases a squamous cell carcinoma, accounts for 1 ~ 5% of the incidence of all tumors. At present, laryngocarcinoma is mainly managed with the integration of surgery and radio- and chemo-therapies. The current development trend of treatment is to impr...
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2020-08-01
|
| Series: | BMC Cancer |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12885-020-07233-1 |
| _version_ | 1819145859357474816 |
|---|---|
| author | Yining Yang Li Li Yongzhe Zheng Qingfeng Liu Xianfeng Wei Xinyuan Gong Wei Wang Peng Lin |
| author_facet | Yining Yang Li Li Yongzhe Zheng Qingfeng Liu Xianfeng Wei Xinyuan Gong Wei Wang Peng Lin |
| author_sort | Yining Yang |
| collection | DOAJ |
| description | Abstract Background Laryngocarcinoma (LC), in most cases a squamous cell carcinoma, accounts for 1 ~ 5% of the incidence of all tumors. At present, laryngocarcinoma is mainly managed with the integration of surgery and radio- and chemo-therapies. The current development trend of treatment is to improve the local control rate of tumor and the quality of life of patients. Intraoperative radiation therapy (IORT) is a radiotherapy that delivers single high dose irradiation at a close range to the tumor bed during the surgical operation process. It has particular radiobiological advantages in protecting normal surrounding tissues by directly applying the irradiation dose to the high-risk tumor bed area. Two forms of IORT, i.e., high dose rate (HDR) brachytherapy and external beam radiotherapy (EBRT, including electron and photono IORT), had been studied before the treatment of head and neck tumors (including laryngocarcinoma). However, no relevant assessment had been carried out on 50KV low-energy X-ray. We are convinced by certain arguments that the application of low-energy X-ray for intraoperative local radiotherapy of laryngocarcinoma can not only achieve the therapeutic effect of IORT but also reduce the incidence of high-energy irradiation related toxic and side effects. The purpose of this study is to observe the safety and short-term efficacy of IORT when used in conjunction with standard of care for the treatment of local advanced laryngocarcinoma (LAL). Methods/design In consideration of the applications of precise targeted IORT in oncosurgery and in line with the application range and reference clinical medical guidances approved by SFDA (ZEISS radiosurgical operation system has been used for the treatment of solid tumors since 31 December, 2013 with an approval from SFDA), we have preliminarily planned the tumors suitable for IORT, determined the members of MDT in our hospital, improved the MDT diagnosis and treatment processes for the tumors, established the standards, indications and contraindications for the application of IORT, determined the indicators to be observed after the treatment of tumors with surgical operations plus IORT, and carried out follow-up visits and statistical analysis. This is a single-arm, prospective Phase II clinical trial of the treatment of LAL patients with IORT + EBRT. The study subjects are followed up for statistics and information of their acute/chronic toxic reactions and local control rate, DFS, and OS etc. The safety and short-term efficacy of the application of IORT as SIB for the treatment of LAL. The sample size of the study is 125 subjects. Discussion The safety and efficacy of IORT for the treatment of head and neck cancers have been proven in studies by multiple institutions (1–3). The purpose of this study is to investigate the maximum safe dose and short-term efficacy of IORT for providing a theoretical basis for clinical trials. Trial registration Trial registration: Clinicaltrials.gov , NCT04278638. Registered 18 February 2020 - prospectively registered, https://clinicaltrials.gov/ct2/show/NCT04278638 |
| first_indexed | 2024-12-22T13:04:43Z |
| format | Article |
| id | doaj.art-73d0d747c1ed4057b952d929b9ba5e78 |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-12-22T13:04:43Z |
| publishDate | 2020-08-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-73d0d747c1ed4057b952d929b9ba5e782022-12-21T18:24:54ZengBMCBMC Cancer1471-24072020-08-012011810.1186/s12885-020-07233-1A prospective, single-arm, phase II clinical trial of intraoperative radiotherapy using a low-energy X-ray source for local advanced Laryngocarcinoma (ILAL): a study protocolYining Yang0Li Li1Yongzhe Zheng2Qingfeng Liu3Xianfeng Wei4Xinyuan Gong5Wei Wang6Peng Lin7Department of Radiotherapy and Department of Otorhinolaryngology Head and Neck Surgery, Tianjin First Central HospitalDepartment of Radiotherapy and Department of Otorhinolaryngology Head and Neck Surgery, Tianjin First Central HospitalDepartment of Radiotherapy and Department of Otorhinolaryngology Head and Neck Surgery, Tianjin First Central HospitalDepartment of Radiotherapy, Tumor Hospital of the Chinese Academy of Medical SciencesDepartment of Radiotherapy and Department of Otorhinolaryngology Head and Neck Surgery, Tianjin First Central HospitalDepartment of Radiotherapy and Department of Otorhinolaryngology Head and Neck Surgery, Tianjin First Central HospitalDepartment of Radiotherapy and Department of Otorhinolaryngology Head and Neck Surgery, Tianjin First Central HospitalDepartment of Radiotherapy and Department of Otorhinolaryngology Head and Neck Surgery, Tianjin First Central HospitalAbstract Background Laryngocarcinoma (LC), in most cases a squamous cell carcinoma, accounts for 1 ~ 5% of the incidence of all tumors. At present, laryngocarcinoma is mainly managed with the integration of surgery and radio- and chemo-therapies. The current development trend of treatment is to improve the local control rate of tumor and the quality of life of patients. Intraoperative radiation therapy (IORT) is a radiotherapy that delivers single high dose irradiation at a close range to the tumor bed during the surgical operation process. It has particular radiobiological advantages in protecting normal surrounding tissues by directly applying the irradiation dose to the high-risk tumor bed area. Two forms of IORT, i.e., high dose rate (HDR) brachytherapy and external beam radiotherapy (EBRT, including electron and photono IORT), had been studied before the treatment of head and neck tumors (including laryngocarcinoma). However, no relevant assessment had been carried out on 50KV low-energy X-ray. We are convinced by certain arguments that the application of low-energy X-ray for intraoperative local radiotherapy of laryngocarcinoma can not only achieve the therapeutic effect of IORT but also reduce the incidence of high-energy irradiation related toxic and side effects. The purpose of this study is to observe the safety and short-term efficacy of IORT when used in conjunction with standard of care for the treatment of local advanced laryngocarcinoma (LAL). Methods/design In consideration of the applications of precise targeted IORT in oncosurgery and in line with the application range and reference clinical medical guidances approved by SFDA (ZEISS radiosurgical operation system has been used for the treatment of solid tumors since 31 December, 2013 with an approval from SFDA), we have preliminarily planned the tumors suitable for IORT, determined the members of MDT in our hospital, improved the MDT diagnosis and treatment processes for the tumors, established the standards, indications and contraindications for the application of IORT, determined the indicators to be observed after the treatment of tumors with surgical operations plus IORT, and carried out follow-up visits and statistical analysis. This is a single-arm, prospective Phase II clinical trial of the treatment of LAL patients with IORT + EBRT. The study subjects are followed up for statistics and information of their acute/chronic toxic reactions and local control rate, DFS, and OS etc. The safety and short-term efficacy of the application of IORT as SIB for the treatment of LAL. The sample size of the study is 125 subjects. Discussion The safety and efficacy of IORT for the treatment of head and neck cancers have been proven in studies by multiple institutions (1–3). The purpose of this study is to investigate the maximum safe dose and short-term efficacy of IORT for providing a theoretical basis for clinical trials. Trial registration Trial registration: Clinicaltrials.gov , NCT04278638. Registered 18 February 2020 - prospectively registered, https://clinicaltrials.gov/ct2/show/NCT04278638http://link.springer.com/article/10.1186/s12885-020-07233-1Local advanced laryngocarcinomaIORTLow-energy X-rayLocal control |
| spellingShingle | Yining Yang Li Li Yongzhe Zheng Qingfeng Liu Xianfeng Wei Xinyuan Gong Wei Wang Peng Lin A prospective, single-arm, phase II clinical trial of intraoperative radiotherapy using a low-energy X-ray source for local advanced Laryngocarcinoma (ILAL): a study protocol BMC Cancer Local advanced laryngocarcinoma IORT Low-energy X-ray Local control |
| title | A prospective, single-arm, phase II clinical trial of intraoperative radiotherapy using a low-energy X-ray source for local advanced Laryngocarcinoma (ILAL): a study protocol |
| title_full | A prospective, single-arm, phase II clinical trial of intraoperative radiotherapy using a low-energy X-ray source for local advanced Laryngocarcinoma (ILAL): a study protocol |
| title_fullStr | A prospective, single-arm, phase II clinical trial of intraoperative radiotherapy using a low-energy X-ray source for local advanced Laryngocarcinoma (ILAL): a study protocol |
| title_full_unstemmed | A prospective, single-arm, phase II clinical trial of intraoperative radiotherapy using a low-energy X-ray source for local advanced Laryngocarcinoma (ILAL): a study protocol |
| title_short | A prospective, single-arm, phase II clinical trial of intraoperative radiotherapy using a low-energy X-ray source for local advanced Laryngocarcinoma (ILAL): a study protocol |
| title_sort | prospective single arm phase ii clinical trial of intraoperative radiotherapy using a low energy x ray source for local advanced laryngocarcinoma ilal a study protocol |
| topic | Local advanced laryngocarcinoma IORT Low-energy X-ray Local control |
| url | http://link.springer.com/article/10.1186/s12885-020-07233-1 |
| work_keys_str_mv | AT yiningyang aprospectivesinglearmphaseiiclinicaltrialofintraoperativeradiotherapyusingalowenergyxraysourceforlocaladvancedlaryngocarcinomailalastudyprotocol AT lili aprospectivesinglearmphaseiiclinicaltrialofintraoperativeradiotherapyusingalowenergyxraysourceforlocaladvancedlaryngocarcinomailalastudyprotocol AT yongzhezheng aprospectivesinglearmphaseiiclinicaltrialofintraoperativeradiotherapyusingalowenergyxraysourceforlocaladvancedlaryngocarcinomailalastudyprotocol AT qingfengliu aprospectivesinglearmphaseiiclinicaltrialofintraoperativeradiotherapyusingalowenergyxraysourceforlocaladvancedlaryngocarcinomailalastudyprotocol AT xianfengwei aprospectivesinglearmphaseiiclinicaltrialofintraoperativeradiotherapyusingalowenergyxraysourceforlocaladvancedlaryngocarcinomailalastudyprotocol AT xinyuangong aprospectivesinglearmphaseiiclinicaltrialofintraoperativeradiotherapyusingalowenergyxraysourceforlocaladvancedlaryngocarcinomailalastudyprotocol AT weiwang aprospectivesinglearmphaseiiclinicaltrialofintraoperativeradiotherapyusingalowenergyxraysourceforlocaladvancedlaryngocarcinomailalastudyprotocol AT penglin aprospectivesinglearmphaseiiclinicaltrialofintraoperativeradiotherapyusingalowenergyxraysourceforlocaladvancedlaryngocarcinomailalastudyprotocol AT yiningyang prospectivesinglearmphaseiiclinicaltrialofintraoperativeradiotherapyusingalowenergyxraysourceforlocaladvancedlaryngocarcinomailalastudyprotocol AT lili prospectivesinglearmphaseiiclinicaltrialofintraoperativeradiotherapyusingalowenergyxraysourceforlocaladvancedlaryngocarcinomailalastudyprotocol AT yongzhezheng prospectivesinglearmphaseiiclinicaltrialofintraoperativeradiotherapyusingalowenergyxraysourceforlocaladvancedlaryngocarcinomailalastudyprotocol AT qingfengliu prospectivesinglearmphaseiiclinicaltrialofintraoperativeradiotherapyusingalowenergyxraysourceforlocaladvancedlaryngocarcinomailalastudyprotocol AT xianfengwei prospectivesinglearmphaseiiclinicaltrialofintraoperativeradiotherapyusingalowenergyxraysourceforlocaladvancedlaryngocarcinomailalastudyprotocol AT xinyuangong prospectivesinglearmphaseiiclinicaltrialofintraoperativeradiotherapyusingalowenergyxraysourceforlocaladvancedlaryngocarcinomailalastudyprotocol AT weiwang prospectivesinglearmphaseiiclinicaltrialofintraoperativeradiotherapyusingalowenergyxraysourceforlocaladvancedlaryngocarcinomailalastudyprotocol AT penglin prospectivesinglearmphaseiiclinicaltrialofintraoperativeradiotherapyusingalowenergyxraysourceforlocaladvancedlaryngocarcinomailalastudyprotocol |