Evaluation of Vaginal Dose in Cervical Cancer Patients Treated With Radiotherapy

NCT03257475 | Unknown

• 1 other identifier: XIAN J
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Cancer

Keywords

cervical cance; vaginal radiation injury; PIBS; R-V; VRL

Outcome Measures

Primary Outcomes (4)

• PIBS/PIBS±2cm dose in Gy

  record the PIBS/PIBS±2cm dose by planning system

  two weeks

• VRL in centimeter

  measure the VRL in MRI

  two weeks

• R-V dose in Gy

  two weeks

• acute and chronic radiation injury incidence of vagina

  acute and chronic radiation injury incidence of vaginaas assessed by CTCAE v4.0

  two years

Interventions

Brachytherapy RADIATION

Intracavitary irradiation starts at the end of the external beam radiation using image-guided CT/SIM.CT/SIM (transverse axis) is done to complete 3/2D treatment planning. Measurement VRL, PIBS and PIBS ± 2cm, R-V were recorded; Brachytherapy plan: Point A: 24-30Gy/4-5f, or 21-28Gy/3-4f HR-CTV: ≥85Gy, IR-CTV 65Gy dose records

Eligibility Criteria

• Age: Up to 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pathologically confirmed cervical cancer patients, FIGO stage ⅠA-ⅣA patients who underwent radical radiotherapy except ⅢA, Any pathological type.

You may qualify if:

• Pathologically confirmed cervical cancer patients;
• FIGO stage ⅠA- ⅣA patients who underwent radical radiotherapy;
• Any pathological type

You may not qualify if:

• FIGO staging of cervical cancer ⅢA;
• Age \> 60 years

Sponsors & Collaborators

• Xi'an Jiaotong University: lead

Study Sites (1)

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, Shaanxi, 710061, China

Location

Related Publications (8)

• Fidarova EF, Berger D, Schussler S, Dimopoulos J, Kirisits C, Georg P, Bachtiary B, Potter 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.

  PMID: 20561694 BACKGROUND

• 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. doi: 10.7314/apjcp.2014.15.8.3619.

  PMID: 24870767 BACKGROUND

• 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.

  PMID: 24456669 BACKGROUND

• Prescribing, Recording, and Reporting Brachytherapy for Cancer of the Cervix. J ICRU. 2013 Apr;13(1-2):NP. doi: 10.1093/jicru/ndw027. No abstract available.

  PMID: 27335496 BACKGROUND

• Kirchheiner K, Nout RA, Lindegaard JC, Haie-Meder C, Mahantshetty U, Segedin B, Jurgenliemk-Schulz IM, Hoskin PJ, Rai B, Dorr W, Kirisits C, Bentzen SM, Potter 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.

  PMID: 26780997 BACKGROUND

• 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.

  PMID: 26883564 BACKGROUND

• Westerveld H, de Leeuw A, Kirchheiner K, Dankulchai P, Oosterveld B, Oinam A, Hudej R, Swamidas J, Lindegaard J, Tanderup K, Potter 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.

  PMID: 27237058 BACKGROUND

• Wang J, Zhang KS, Wang T, Liu Z, Wang RH, Zhang FQ, Yu L, Ran L, He JL, Wang YL, Wei LC, Shi M, Wang GQ, Wu CQ, Kang QJ, Yang J, Li S, Yang FY, Liu BG, Liu JY, Shi F, Su J, Yuan W, Drokow EK. Vaginal dose of radical radiotherapy for cervical cancer in China: a multicenter study. BMC Cancer. 2019 Dec 16;19(1):1219. doi: 10.1186/s12885-019-6423-5.

  PMID: 31842811 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Juan Wang, Ph.D

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 14, 2017
• First Posted: August 22, 2017
• Study Start: March 1, 2017
• Primary Completion: February 28, 2019
• Study Completion: August 30, 2019
• Last Updated: August 22, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)