Cervical Cancer Clinical Trial
Official title:
Evaluation of Vaginal Dose in Cervical Cancer Patients Treated With Radiotherapy
Verified date | August 2017 |
Source | Health Science Center of Xi’an Jiaotong University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Cervical cancer is the most common malignant in women with the average five-year overall survival rate as high as 70%. Radiation therapy is the main treatment for cervical cancer. Vagina is one of the important organ at risk and also a target organ in the treatment of cervical cancer patients. Vaginal radiation has serious related complications that affect the quality of life of patients and therefore needs much clinical attention. But due to lack of sufficient evidence, the clinical dose to the vagina is limited. ICRU-89 defined the recto-vaginal reference point (R-V) as a reference point for vaginal dose assessment. However, the R-V position is affected by applicator placement, vaginal packing and other factors hence the dose point only do not represent the entire vaginal radiation dose resulting in some clinical limitations. The latest research in Europe proposed that PIBS(Posterior-Inferior Border of Symphysis) / PIBS ± 2cm and VRL (vaginal reference length) may be more reasonable to use to assess vagina radiation doses, but it remains to be further clinically investigated. Therefore, this study intends to perform radical radiotherapy in cervical cancer patients and also by recruiting local and foreign hospitals into this study by recording its PIBS/ PIBS ± 2cm, VRL, R-V point dose, acute and chronic radiation injury incidence of vagina and other useful data. T-test and chi-square will be used to compare the data between Asian and European women. Correlation analysis will be used to determine if there is a relation between R-V and PIBS point dose. Furthermore, logic and or COX regression model to evaluate PIBS / PIBS ± 2cm and R-V point doses of vaginal radiation injury relationships, while exploring other relevant factors causing vaginal radiation injury. This is eventually expected to provide a scientific, simple and reliable reference point for vaginal dose assessment and clinical dose limit.
Status | Active, not recruiting |
Enrollment | 500 |
Est. completion date | August 30, 2019 |
Est. primary completion date | February 28, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A to 60 Years |
Eligibility |
Inclusion Criteria: - Pathologically confirmed cervical cancer patients; - FIGO stage ?A- ?A patients who underwent radical radiotherapy; - Any pathological type Exclusion Criteria: - FIGO staging of cervical cancer ?A; - Age > 60 years |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Xi'an Jiao Tong University | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
Health Science Center of Xi’an Jiaotong University |
China,
Fidarova EF, Berger D, Schüssler S, Dimopoulos J, Kirisits C, Georg P, Bachtiary B, Pötter R. Dose volume parameter D2cc does not correlate with vaginal side effects in individual patients with cervical cancer treated within a defined treatment protocol with very high brachytherapy doses. Radiother Oncol. 2010 Oct;97(1):76-9. doi: 10.1016/j.radonc.2010.05.005. Epub 2010 Jun 17. — View Citation
Kirchheiner K, Nout RA, Lindegaard JC, Haie-Meder C, Mahantshetty U, Segedin B, Jürgenliemk-Schulz IM, Hoskin PJ, Rai B, Dörr W, Kirisits C, Bentzen SM, Pötter R, Tanderup K; EMBRACE Collaborative Group. Dose-effect relationship and risk factors for vaginal stenosis after definitive radio(chemo)therapy with image-guided brachytherapy for locally advanced cervical cancer in the EMBRACE study. Radiother Oncol. 2016 Jan;118(1):160-6. doi: 10.1016/j.radonc.2015.12.025. Epub 2016 Jan 9. — View Citation
Murakami N, Kasamatsu T, Sumi M, Yoshimura R, Harada K, Kitaguchi M, Sekii S, Takahashi K, Yoshio K, Inaba K, Morota M, Ito Y, Itami J. Vaginal tolerance of CT based image-guided high-dose rate interstitial brachytherapy for gynecological malignancies. Radiat Oncol. 2014 Jan 23;9:31. doi: 10.1186/1748-717X-9-31. — View Citation
Prescribing, Recording, and Reporting Brachytherapy for Cancer of the Cervix. J ICRU. 2013 Apr;13(1-2):NP. doi: 10.1093/jicru/ndw027. — View Citation
Rai B, Dhanireddy B, Patel FD, Kumari R, Oinam AS, Simha V, Sharma S. Vaginal dose, toxicity and sexual outcomes in patients of cervical cancer undergoing image based brachytherapy. Asian Pac J Cancer Prev. 2014;15(8):3619-23. — View Citation
Susko M, Craciunescu O, Meltsner S, Yang Y, Steffey B, Cai J, Chino J. Vaginal Dose Is Associated With Toxicity in Image Guided Tandem Ring or Ovoid-Based Brachytherapy. Int J Radiat Oncol Biol Phys. 2016 Apr 1;94(5):1099-105. doi: 10.1016/j.ijrobp.2015.12.360. Epub 2015 Dec 19. — View Citation
Westerveld H, de Leeuw A, Kirchheiner K, Dankulchai P, Oosterveld B, Oinam A, Hudej R, Swamidas J, Lindegaard J, Tanderup K, Pötter R, Kirisits C; EMBRACE Collaborative Group. Multicentre evaluation of a novel vaginal dose reporting method in 153 cervical cancer patients. Radiother Oncol. 2016 Sep;120(3):420-427. doi: 10.1016/j.radonc.2016.05.002. Epub 2016 May 26. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PIBS/PIBS±2cm dose in Gy | record the PIBS/PIBS±2cm dose by planning system | two weeks | |
Primary | VRL in centimeter | measure the VRL in MRI | two weeks | |
Primary | R-V dose in Gy | two weeks | ||
Primary | acute and chronic radiation injury incidence of vagina | acute and chronic radiation injury incidence of vaginaas assessed by CTCAE v4.0 | two years |
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