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

• Register: ClinicalTrials.gov
• Last refreshed on: 28 November 2016
• Main ID: NCT02957266
• Date of registration: 03/11/2016
• Prospective Registration: No
• Primary sponsor: The National Center of Oncology, Azerbaijan
• Public title: Cervical Cancer Radiotherapy by Use of VMAT, Individualized Polyradiosensitization and Interstitial Brachytherapy CERVIPIB
• Scientific title: Improvement of Locally Advanced Cervical Cancer Radiotherapy Efficacy by Use of Volumetric Arc Therapy, Individualized Polyradiosensitization and Interstitial Brachytherapy
• Date of first enrolment: March 2015
• Target sample size: 400
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02957266
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Azerbaijan

Contacts

• Name: Kamal Akbarov, PhD
• Affiliation: National Center of Oncology

• Name: Kamal Akbarov, PhD

• Name: Aziz Aliyev, Professor

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Cervical Cancer

Intervention(s)

Genetic: BRAF

Genetic: RRM1

Radiation: Interstitial brachytherapy

Drug: Cisplatin

Drug: Gemcitabine

Genetic: PIK3CA

Genetic: KRAS

Radiation: Volumetric Arc Radiotherapy

Primary Outcome(s)

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

Secondary Outcome(s)

Incidence of late toxicity [Time Frame: Up to 2 years after completion of radiation therapy]

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]

Secondary ID(s)

MOM-0001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors