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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02957266 |
Recruitment Status : Unknown
Verified November 2016 by Kamal Akbarov, The National Center of Oncology, Azerbaijan.
Recruitment status was: Recruiting
First Posted : November 6, 2016
Last Update Posted : November 15, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 |

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 |
- Relapse Rate (local and/or distant) and Number of Deaths Due to Any Cause [ Time Frame: 4 years ]
- 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 ]

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.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

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
Contact: Kamal Akbarov, PhD | +994503362974 | akperovkamal@yahoo.com |
Azerbaijan | |
National Center of Oncology | Recruiting |
Baku, Azerbaijan, AZ1011 | |
Contact: Aziz Aliyev, Professor +994504807021 internationalnoc@gmail.com |
Principal Investigator: | Kamal Akbarov, PhD | National Center of Oncology |
Responsible Party: | Kamal Akbarov, Radiation Oncologist, PhD, The National Center of Oncology, Azerbaijan |
ClinicalTrials.gov Identifier: | NCT02957266 |
Other Study ID Numbers: |
MOM-0001 |
First Posted: | November 6, 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 |
cervical cancer interstitial brachytherapy gemcitabine volumetric arc therapy |
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases Gemcitabine 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 |