Cervical Cancer
Conditions
Keywords
cervical cancer, interstitial brachytherapy, gemcitabine, volumetric arc therapy
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.
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.
Interventions
RADIATIONVolumetric Arc Radiotherapy
Volumetric Arc Radiotherapy
RADIATIONInterstitial brachytherapy
Interstitial High Dose Rate Brachytherapy
DRUGCisplatin
Weekly Cisplatin
DRUGGemcitabine
Weekly Gemcitabine
GENETICPIK3CA
PIK3CA mutations rate
GENETICKRAS
KRAS mutations rate
GENETICBRAF
BRAF mutations rate
GENETICRRM1
RRM1 mutations rate
Sponsors
The National Center of Oncology, Azerbaijan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse Rate (local and/or distant) and Number of Deaths Due to Any Cause | 4 years |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Progressive Disease | 4 years |
| Incidence of acute toxicity | Up to 30 days after completion of radiation therapy |
| Incidence of late toxicity | Up to 2 years after completion of radiation therapy |
Countries
Azerbaijan
Contacts
Primary ContactKamal Akbarov, PhD
Outcome results
None listed