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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Cervical Cancer

Keywords

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cervical cancer interstitial brachytherapy gemcitabine volumetric arc therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type GENETIC

BRAF mutations rate

RRM1

Intervention Type GENETIC

RRM1 mutations rate

Interventions

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CDDP Gemcitabine Hydrochloride

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Kamal Akbarov

Radiation Oncologist, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kamal Akbarov, PhD

Role: PRINCIPAL_INVESTIGATOR

National Center of Oncology

Locations

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National Center of Oncology

Baku, Baku, Azerbaijan

Site Status RECRUITING

Countries

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Azerbaijan

Central Contacts

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Kamal Akbarov, PhD

Role: CONTACT

Phone: +994503362974

Email: [email protected]

Facility Contacts

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Aziz Aliyev, Professor

Role: primary

Other Identifiers

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MOM-0001

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Classical treatment

Volumetric Arc Radiotherapy

Cisplatin

PIK3CA

KRAS

BRAF

RRM1

GemInterBraVMAT

Volumetric Arc Radiotherapy

Interstitial brachytherapy

Cisplatin

Gemcitabine

PIK3CA

KRAS

BRAF

RRM1

Interventions

Volumetric Arc Radiotherapy

Interstitial brachytherapy

Cisplatin

Gemcitabine

PIK3CA

KRAS

BRAF

RRM1

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

The National Center of Oncology, Azerbaijan

Responsible Party

Kamal Akbarov

Principal Investigators

Kamal Akbarov, PhD

Locations

National Center of Oncology

Countries

Central Contacts

Kamal Akbarov, PhD

Facility Contacts

Aziz Aliyev, Professor

Other Identifiers

MOM-0001