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

Cervical Cancer Clinical Trial

— CERVIPIB  

Official title:

Improvement of Locally Advanced Cervical Cancer Radiotherapy Efficacy by Use of Volumetric Arc Therapy, Individualized Polyradiosensitization and Interstitial Brachytherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02957266
• Other study ID #: MOM-0001
• Status: Recruiting
• Phase: Phase 3
• First received: November 3, 2016
• Last updated: November 14, 2016
• Start date: March 2015
• Est. completion date: December 2020

Study information

• Verified date: November 2016
• Source: The National Center of Oncology, Azerbaijan
• Contact: Kamal Akbarov, PhD
• Phone: +994503362974
• Email: akperovkamal[@]yahoo.com
• Is FDA regulated: No
• Health authority: Azerbaijan: National Center of Oncology
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Radiation:
• Volumetric Arc Radiotherapy
Volumetric Arc Radiotherapy
• Interstitial brachytherapy
Interstitial High Dose Rate Brachytherapy

Drug:
• Cisplatin
Weekly Cisplatin
• Gemcitabine
Weekly Gemcitabine

Genetic:
• PIK3CA
PIK3CA mutations rate
• KRAS
KRAS mutations rate
• BRAF
BRAF mutations rate
• RRM1
RRM1 mutations rate

Locations

Country	Name	City	State
Azerbaijan	National Center of Oncology	Baku

Sponsors (1)

Lead Sponsor	Collaborator
The National Center of Oncology, Azerbaijan

Country where clinical trial is conducted

Azerbaijan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse Rate (local and/or distant) and Number of Deaths Due to Any Cause		4 years	No
Secondary	Number of Participants With Progressive Disease		4 years	No
Secondary	Incidence of acute toxicity		Up to 30 days after completion of radiation therapy	Yes
Secondary	Incidence of late toxicity		Up to 2 years after completion of radiation therapy	Yes