Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Radiation: Volumetric Arc Radiotherapy Radiation: Interstitial brachytherapy Drug: Cisplatin Drug: Gemcitabine Genetic: PIK3CA Genetic: KRAS Genetic: BRAF Genetic: RRM1 Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improvement of Locally Advanced Cervical Cancer Radiotherapy Efficacy by Use of Volumetric Arc Therapy, Individualized Polyradiosensitization and Interstitial Brachytherapy
Study Start Date : March 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
Active Comparator: Classical treatment
Classical concurrent cisplatin based chemoradiotherapy of cervical cancer. PIK3CA, KRAS, BRAF and RRM1 mutations rates.
Radiation: Volumetric Arc Radiotherapy
Volumetric Arc Radiotherapy

Drug: Cisplatin
Weekly Cisplatin
Other Name: CDDP

Genetic: PIK3CA
PIK3CA mutations rate

Genetic: KRAS
KRAS mutations rate

Genetic: BRAF
BRAF mutations rate

Genetic: RRM1
RRM1 mutations rate

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.

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




Primary Outcome Measures :
  1. Relapse Rate (local and/or distant) and Number of Deaths Due to Any Cause [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. Number of Participants With Progressive Disease [ Time Frame: 4 years ]
  2. Incidence of acute toxicity [ Time Frame: Up to 30 days after completion of radiation therapy ]
  3. Incidence of late toxicity [ Time Frame: Up to 2 years after completion of radiation therapy ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957266


Contacts
Layout table for location contacts
Contact: Kamal Akbarov, PhD +994503362974 akperovkamal@yahoo.com

Locations
Layout table for location information
Azerbaijan
National Center of Oncology Recruiting
Baku, Azerbaijan, AZ1011
Contact: Aziz Aliyev, Professor    +994504807021    internationalnoc@gmail.com   
Sponsors and Collaborators
The National Center of Oncology, Azerbaijan
Investigators
Layout table for investigator information
Principal Investigator: Kamal Akbarov, PhD National Center of Oncology

Layout table for additonal information
Responsible Party: Kamal Akbarov, Radiation Oncologist, PhD, The National Center of Oncology, Azerbaijan
ClinicalTrials.gov Identifier: NCT02957266     History of Changes
Other Study ID Numbers: MOM-0001
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kamal Akbarov, The National Center of Oncology, Azerbaijan:
cervical cancer
interstitial brachytherapy
gemcitabine
volumetric arc therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Gemcitabine
Cisplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs