Cervical CancerPhase 3CERVIPIBNCT02957266
Cervical Cancer Radiotherapy by Use of VMAT, Individualized Polyradiosensitization and Interstitial Brachytherapy
A Phase 3 study testing Volumetric Arc Radiotherapy, Interstitial brachytherapy and Cisplatin in people with Cervical Cancer, run by The National Center of Oncology, Azerbaijan at 1 site in Azerbaijan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Volumetric Arc Radiotherapy, Interstitial brachytherapy and Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteAzerbaijan
- Study dates
- Mar 2015to Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Azerbaijan1 site, 1 recruiting
- Recruiting
National Center of Oncology
Baku, Baku City, AZ1011
Aziz Aliyev, Professor, +994504807021, internationalnoc@gmail.com
About this study
Official title: Improvement of Locally Advanced Cervical Cancer Radiotherapy Efficacy by Use of Volumetric Arc Therapy, Individualized Polyradiosensitization and Interstitial Brachytherapy
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.
Read the 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.
- Conditions
- Cervical Cancer
- Being tested
- Volumetric Arc Radiotherapy, Interstitial brachytherapy, Cisplatin, Gemcitabine, PIK3CA
- Keywords
- cervical cancer, interstitial brachytherapy, gemcitabine, volumetric arc therapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volumetric Arc RadiotherapyRadiation
Volumetric Arc Radiotherapy
Interstitial brachytherapyRadiation
Interstitial High Dose Rate Brachytherapy
CisplatinDrug
Also called CDDP
Weekly Cisplatin
GemcitabineDrug
Also called Gemcitabine Hydrochloride
Weekly Gemcitabine
PIK3CAGenetic
PIK3CA mutations rate
KRASGenetic
KRAS mutations rate
BRAFGenetic
BRAF mutations rate
RRM1Genetic
RRM1 mutations rate
| Study group | Role | What they receive |
|---|---|---|
| Classical treatment | Active comparator | Classical concurrent cisplatin based chemoradiotherapy of cervical cancer. PIK3CA, KRAS, BRAF and RRM1 mutations rates. Receives: Radiation: Volumetric Arc Radiotherapy; Drug: Cisplatin; Genetic: PIK3CA; Genetic: KRAS; Genetic: BRAF; Genetic: RRM1 |
| GemInterBraVMAT | Experimental | 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. Receives: Radiation: Volumetric Arc Radiotherapy; Radiation: Interstitial brachytherapy; Drug: Cisplatin; Drug: Gemcitabine; Genetic: PIK3CA; Genetic: KRAS; Genetic: BRAF; Genetic: RRM1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse Rate (local and/or distant) and Number of Deaths Due to Any Cause
Measured: 4 years
Secondary outcomes (3)
Number of Participants With Progressive Disease
Measured: 4 years
Incidence of acute toxicity
Measured: Up to 30 days after completion of radiation therapy
Incidence of late toxicity
Measured: Up to 2 years after completion of radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startMar 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The National Center of Oncology, Azerbaijan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kamal Akbarov, The National Center of Oncology, Azerbaijan
- Investigators
- Kamal Akbarov, PhD, Principal investigator, National Center of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957266
- Sponsor's protocol ID
- MOM-0001
- Acronym
- CERVIPIB
- Status last verified
- Nov 2016
- First submitted
- 3 Nov 2016
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Locally Advanced Cervical Cancer Radiotherapy Efficacy by Use of Volumetric Arc Therapy, Individualized Polyradiosensitization and Interstitial Brachytherapy
- ClinicalTrials.gov ID
- NCT02957266
- Acronym / sponsor ID
- CERVIPIB / MOM-0001
- Conditions
- Cervical Cancer
- Keywords
- cervical cancer, interstitial brachytherapy, gemcitabine, volumetric arc therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The National Center of Oncology, AzerbaijanOther government
- Study start
- Mar 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 7 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classical treatment | Active comparator | Radiation: Volumetric Arc Radiotherapy, Drug: Cisplatin, Genetic: PIK3CA, Genetic: KRAS, Genetic: BRAF, Genetic: RRM1Classical concurrent cisplatin based chemoradiotherapy of cervical cancer. PIK3CA, KRAS, BRAF and RRM1 mutations rates. |
| GemInterBraVMAT | Experimental | Radiation: Volumetric Arc Radiotherapy, Radiation: Interstitial brachytherapy, Drug: Cisplatin, Drug: Gemcitabine, Genetic: PIK3CA, Genetic: KRAS, Genetic: BRAF, Genetic: RRM1Concurrent 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volumetric Arc RadiotherapyVolumetric Arc Radiotherapy | Radiation | Classical treatment, GemInterBraVMAT |
| Interstitial brachytherapyInterstitial High Dose Rate Brachytherapy | Radiation | GemInterBraVMAT |
| CisplatinAlso: CDDPWeekly Cisplatin | Drug | Classical treatment, GemInterBraVMAT |
| GemcitabineAlso: Gemcitabine HydrochlorideWeekly Gemcitabine | Drug | GemInterBraVMAT |
| PIK3CAPIK3CA mutations rate | Genetic | Classical treatment, GemInterBraVMAT |
| KRASKRAS mutations rate | Genetic | Classical treatment, GemInterBraVMAT |
| BRAFBRAF mutations rate | Genetic | Classical treatment, GemInterBraVMAT |
| RRM1RRM1 mutations rate | Genetic | Classical treatment, GemInterBraVMAT |
Primary outcome
Relapse Rate (local and/or distant) and Number of Deaths Due to Any Cause
Time frame: 4 years
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamal Akbarov, PhD principal investigator
National Center of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Volumetric Arc Radiotherapy, Interstitial brachytherapy and Cisplatin in people with Cervical Cancer, run by The National Center of Oncology, Azerbaijan at 1 site in Azerbaijan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Azerbaijan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kamal Akbarov, PhD (+994503362974, akperovkamal@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse Rate (local and/or distant) and Number of Deaths Due to Any Cause (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.