Clinical Trials /

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

NCT02957266

Description:

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.

Related Conditions:
  • Cervical Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Cervical Cancer Radiotherapy by Use of VMAT, Individualized Polyradiosensitization and Interstitial Brachytherapy
  • Official Title: Improvement of Locally Advanced Cervical Cancer Radiotherapy Efficacy by Use of Volumetric Arc Therapy, Individualized Polyradiosensitization and Interstitial Brachytherapy

Clinical Trial IDs

  • ORG STUDY ID: MOM-0001
  • NCT ID: NCT02957266

Conditions

  • Cervical Cancer

Interventions

DrugSynonymsArms
CisplatinCDDPClassical treatment
GemcitabineGemcitabine HydrochlorideGemInterBraVMAT

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Classical treatmentActive ComparatorClassical concurrent cisplatin based chemoradiotherapy of cervical cancer. PIK3CA, KRAS, BRAF and RRM1 mutations rates.
  • Cisplatin
GemInterBraVMATExperimentalConcurrent 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.
  • Cisplatin
  • Gemcitabine

Eligibility Criteria

        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
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Relapse Rate (local and/or distant) and Number of Deaths Due to Any Cause
Time Frame:4 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Number of Participants With Progressive Disease
Time Frame:4 years
Safety Issue:
Description:
Measure:Incidence of acute toxicity
Time Frame:Up to 30 days after completion of radiation therapy
Safety Issue:
Description:
Measure:Incidence of late toxicity
Time Frame:Up to 2 years after completion of radiation therapy
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:The National Center of Oncology, Azerbaijan

Trial Keywords

  • cervical cancer
  • interstitial brachytherapy
  • gemcitabine
  • volumetric arc therapy

Last Updated

November 14, 2016