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.
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
Interventions
Drug | Synonyms | Arms |
---|
Cisplatin | CDDP | Classical treatment |
Gemcitabine | Gemcitabine Hydrochloride | GemInterBraVMAT |
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
Name | Type | Description | Interventions |
---|
Classical treatment | Active Comparator | Classical concurrent cisplatin based chemoradiotherapy of cervical cancer. PIK3CA, KRAS, BRAF and RRM1 mutations rates. | |
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. | |
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: | Unknown status |
Lead Sponsor: | The National Center of Oncology, Azerbaijan |
Trial Keywords
- cervical cancer
- interstitial brachytherapy
- gemcitabine
- volumetric arc therapy
Last Updated
November 15, 2016