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Status unknownNCT03257475Updated Aug 22, 2017

Evaluation of Vaginal Dose in Cervical Cancer Patients Treated With Radiotherapy

An observational study in Cervical Cancer, sponsored by Xi'an Jiaotong University. Status unknown at 1 site in China. Open to female participants aged Up to 60 Years. Per ClinicalTrials.gov, last updated 2017-08-22.

Sponsored by Xi'an Jiaotong University · Observational

The sponsor has not verified this record recently (last verified Aug 2017), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
500
Ages
Up to 60 Years
Sex
Female
01

Study 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.

Read the detailed description
  1. a detailed record of the irradiation dose and R-V point dose for all patients PIBS / PIBS ± 2cm, VRL data were taken.
  2. according to CTCAE v3.0 standard, accurate and detailed record of patient treatment, after treatment of 2 years and the incidence of vaginal complications were recorded.
  3. COX regression model was used to find dose-effect relationship between the reference point and vaginal complications.

Clinical Scheme:

Inclusion criteria: Pathologically confirmed cervical cancer patients, FIGO stage ⅠA- ⅣA patients who underwent radical radiotherapy, Any pathological type

Exclusion criteria: FIGO staging of cervical cancer ⅢA; Age > 60 years due to vaginal stenosis during the treatment course

  1. pre-treatment: Abdominal and Chest CT scan before treatment. Patients were given pelvic MRI after EBRT to measure VRL before the start of brachytherapy.
  2. 3DCRT / IMRT was used and according to RTOG target outlined recommendation dose of 46-50Gy / 23-25f; recording PIBS WP and R-V WP dose.

  3. Intracavitary irradiation starts at the end of the external beam radiation using image-guided CT / SIM. catheterization of full bladder. Patients were advice to have empty rectum before CT scan

    The first treatment method:

    1. Catheterization: placement of catheter inside bladder and injection of contrast agent-containing 7ml liquid
    2. Place uterine and vaginal applicator device (must double the bulb), vaginal orifices ball from 3cm, and record
    3. Vaginal packing with gauze is done to keep the applicator fixed.
    4. Barium into the rectum and anal canal.
    5. CT/SIM (transverse axis) is done to complete 3D / 2D treatment planning. measurement VRL, PIBS and PIBS ± 2cm, R-V were recorded;
    6. Brachytherapy plan: Point A: 24-30Gy / 4-5f, or 21-28Gy / 3-4f HR-CTV: ≥85Gy, IR-CTV 65Gy dose records;
  4. Concurrent chemotherapy: DDP 30-40mg / m2 * 5w or T 135mg / m2D1 + DDP 30mg / m2 d1-3;
  5. vaginal washing method is every day from the beginning of radiation therapy for six months. After 6 months, it was done twice per week for 2 years.
  6. vaginal radiation complications were recorded according to CTCAE 3.0 standard
  7. Gynecological examination and MRI was performed before radiotherapy and brachytherapy treatment and also after the entire treatment period. Patients follow-up was done on the 1,3,6,9,12,18 and 24th month after treatment during which vaginal radiation complication were evaluated according to CTCAE 3.0 standard
  8. COX regression model was used to find dose-effect relationship between the reference point and vaginal complications.
02

Conditions studied

  • Cervical Cancer

Keywords

  • cervical cance
  • vaginal radiation injury
  • PIBS
  • R-V
  • VRL
03

Who can participate

Ages eligible
Up to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • FIGO staging of cervical cancer ⅢA;
  • Age > 60 years
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Interventions

  • RadiationBrachytherapy

    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

05

What researchers measure

Primary outcomes

  1. PIBS/PIBS±2cm dose in Gy

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

    Time frame: two weeks

  2. VRL in centimeter

    measure the VRL in MRI

    Time frame: two weeks

  3. R-V dose in Gy

    Time frame: two weeks

  4. acute and chronic radiation injury incidence of vagina

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

    Time frame: two years

06

Study locations

1 site
  • The First Affiliated Hospital of Xi'an Jiao Tong University
    Xi'an, Shaanxi 710061, China
07

References and documents

Publications

  • 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. PubMed 20561694 ↗
  • 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. PubMed 24870767 ↗
  • 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. PubMed 24456669 ↗
  • 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. PubMed 27335496 ↗
  • 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. PubMed 26780997 ↗
  • 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. PubMed 26883564 ↗
  • 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. PubMed 27237058 ↗
  • 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. PubMed 31842811 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03257475
Lead sponsor
Xi'an Jiaotong University
Responsible party
Liu Zi (Professor, Xi'an Jiaotong University) — Principal investigator
First posted
Aug 22, 2017
Start date
Mar 1, 2017
Primary completion
Feb 28, 2019 (estimated)
Completion
Aug 30, 2019 (estimated)
Last update
Aug 22, 2017

Study contacts

Juan Wang, Ph.D
principal investigator · First Affiliated Hospital Xi'an Jiaotong University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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