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Cervical Cancer Radiotherapy by Use of VMAT, Individualized Polyradiosensitization and Interstitial Brachytherapy (CERVIPIB)

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ClinicalTrials.gov Identifier: NCT02957266
Recruitment Status : Recruiting
First Posted : November 7, 2016
Last Update Posted : November 15, 2016
Sponsor:
Information provided by (Responsible Party):
Kamal Akbarov, The National Center of Oncology, Azerbaijan

Tracking Information
First Submitted Date  ICMJE November 3, 2016
First Posted Date  ICMJE November 7, 2016
Last Update Posted Date November 15, 2016
Study Start Date  ICMJE March 2015
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2016)
Relapse Rate (local and/or distant) and Number of Deaths Due to Any Cause [ Time Frame: 4 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02957266 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2016)
  • Number of Participants With Progressive Disease [ Time Frame: 4 years ]
  • Incidence of acute toxicity [ Time Frame: Up to 30 days after completion of radiation therapy ]
  • Incidence of late toxicity [ Time Frame: Up to 2 years after completion of radiation therapy ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2016)
  • Number of Participants With Progressive Disease [ Time Frame: 4 years ]
  • Incidence of acute toxicity [ Time Frame: Up to 30 days after completion of radiation therapy ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cervical Cancer Radiotherapy by Use of VMAT, Individualized Polyradiosensitization and Interstitial Brachytherapy
Official Title  ICMJE Improvement of Locally Advanced Cervical Cancer Radiotherapy Efficacy by Use of Volumetric Arc Therapy, Individualized Polyradiosensitization and Interstitial Brachytherapy
Brief Summary The purpose of this study is to define an effectiveness of concurrent chemoradiotherapy of cervical cancer patients treated by VMAT (volumetric arc therapy) based external beam radiotherapy, polyradiosensitization by cisplatin and gemcitabine and interstitial brachytherapy.
Detailed Description Now cisplatin based concurrent chemoradiotherapy for cervical cancer is a standard treatment modality. But we consider that the treatment results could be improved by several ways: 1. use of VMAT (volumetric arc therapy) based external beam radiotherapy could decrease toxicity by reducing of unnecessarily irradiated tissue volumes; 2. in addition to cisplatin gemcitabine could enhance tumor cell damaging effect of radiation; 3. interstitial brachytherapy could provide higher radiation dose boost to high risk tumor volume while sparing surrounding organs at risk.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cervical Cancer
Intervention  ICMJE
  • Radiation: Volumetric Arc Radiotherapy
    Volumetric Arc Radiotherapy
  • Radiation: Interstitial brachytherapy
    Interstitial High Dose Rate Brachytherapy
  • Drug: Cisplatin
    Weekly Cisplatin
    Other Name: CDDP
  • Drug: Gemcitabine
    Weekly Gemcitabine
    Other Name: Gemcitabine Hydrochloride
  • Genetic: PIK3CA
    PIK3CA mutations rate
  • Genetic: KRAS
    KRAS mutations rate
  • Genetic: BRAF
    BRAF mutations rate
  • Genetic: RRM1
    RRM1 mutations rate
Study Arms  ICMJE
  • Active Comparator: Classical treatment
    Classical concurrent cisplatin based chemoradiotherapy of cervical cancer. PIK3CA, KRAS, BRAF and RRM1 mutations rates.
    Interventions:
    • Radiation: Volumetric Arc Radiotherapy
    • Drug: Cisplatin
    • Genetic: PIK3CA
    • Genetic: KRAS
    • Genetic: BRAF
    • Genetic: RRM1
  • Experimental: GemInterBraVMAT

    Concurrent chemoradiotherapy of cervical cancer patients treated by VMAT (volumetric arc radiotherapy) based external beam radiotherapy, polyradiosensitization by cisplatin and gemcitabine and interstitial brachytherapy.

    PIK3CA, KRAS, BRAF and RRM1 mutations rates.

    Interventions:
    • Radiation: Volumetric Arc Radiotherapy
    • Radiation: Interstitial brachytherapy
    • Drug: Cisplatin
    • Drug: Gemcitabine
    • Genetic: PIK3CA
    • Genetic: KRAS
    • Genetic: BRAF
    • Genetic: RRM1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 3, 2016)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Histologically confirmed primary invasive carcinoma of the uterine cervix Previously untreated disease Any cell type Stage IB2, IIA, IIB, IIIA, IIIB, or IVA Para-aortic lymph nodes negative by radiologic evaluation or by biopsy if CT scan is suspicious for adenopathy No known metastases to scalene nodes or other organs outside the radiotherapy field Study enrollment within 8 weeks of diagnosis Performance status - GOG 0-2 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Creatinine less than 2.0 mg/dL No renal abnormalities (e.g., pelvic kidney, horseshoe kidney, or renal transplantation) that would require modification of radiotherapy fields No bilateral ureteral obstruction allowed unless treated with stent or nephrostomy tube Not pregnant Fertile patients must use effective contraception No septicemia or severe infection No circumstance that would preclude study completion or follow-up No other malignancy within the past 5 years except nonmelanoma skin cancer No prior cytotoxic chemotherapy No prior pelvic or abdominal radiotherapy No prior therapy for this malignancy

Exclusion Criteria:

Pregnancy or Breast-Feeding: Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events.(Note: Serum Pregnancy tests must be obtained in women of child bearing potential). Sexually active females may not participate unless they have agreed to use an effective contraceptive method (such as abstinence, diaphragm, condom, or intrauterine device) to prevent pregnancy for the duration of the study.

Growth factor(s): Growth factors that support platelet or white cell number or function must not have been administered within the past 28 days.

Erythropoietic drug(s): Erythropoietin or related hormones must not have been administered within the past 28 days.

Infection: Patients who have an uncontrolled infection. Evidence of distant metastases Prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years.

Prior systemic chemotherapy within the last three years. Prior radiotherapy to the pelvis

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kamal Akbarov, PhD +994503362974 akperovkamal@yahoo.com
Listed Location Countries  ICMJE Azerbaijan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02957266
Other Study ID Numbers  ICMJE MOM-0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kamal Akbarov, The National Center of Oncology, Azerbaijan
Study Sponsor  ICMJE The National Center of Oncology, Azerbaijan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kamal Akbarov, PhD National Center of Oncology
PRS Account The National Center of Oncology, Azerbaijan
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP