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

NCT02957266 | Unknown Phase 3

• 1 other identifier: MOM-0001
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Keywords

cervical cancer; interstitial brachytherapy; gemcitabine; volumetric arc therapy

Outcome Measures

Primary Outcomes (1)

• Relapse Rate (local and/or distant) and Number of Deaths Due to Any Cause

  4 years

Secondary Outcomes (3)

• 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

Study Arms (2)

Classical treatment

ACTIVE COMPARATOR

Classical concurrent cisplatin based chemoradiotherapy of cervical cancer. PIK3CA, KRAS, BRAF and RRM1 mutations rates.

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.

Radiation: Volumetric Arc Radiotherapy; Radiation: Interstitial brachytherapy; Drug: Cisplatin; Drug: Gemcitabine; Genetic: PIK3CA; Genetic: KRAS; Genetic: BRAF; Genetic: RRM1

Interventions

Volumetric Arc Radiotherapy RADIATION

Volumetric Arc Radiotherapy

Classical treatment; GemInterBraVMAT

Interstitial brachytherapy RADIATION

Interstitial High Dose Rate Brachytherapy

GemInterBraVMAT

Cisplatin DRUG

Weekly Cisplatin

Also known as: CDDP

Classical treatment; GemInterBraVMAT

Gemcitabine DRUG

Weekly Gemcitabine

Also known as: Gemcitabine Hydrochloride

GemInterBraVMAT

PIK3CA GENETIC

PIK3CA mutations rate

Classical treatment; GemInterBraVMAT

KRAS GENETIC

KRAS mutations rate

Classical treatment; GemInterBraVMAT

BRAF GENETIC

BRAF mutations rate

Classical treatment; GemInterBraVMAT

RRM1 GENETIC

RRM1 mutations rate

Classical treatment; GemInterBraVMAT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The National Center of Oncology, Azerbaijan: lead

Study Sites (1)

National Center of Oncology

Baku, Baku, AZ1011, Azerbaijan

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Brachytherapy; Cisplatin; Gemcitabine; Proto-Oncogene Proteins c-raf

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; raf Kinases; MAP Kinase Kinase Kinases; Protein Serine-Threonine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Proto-Oncogene Proteins; Oncogene Proteins; Neoplasm Proteins

Study Officials

• Kamal Akbarov, PhD

  National Center of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kamal Akbarov, PhD

CONTACT

+994503362974; akperovkamal@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist, PhD

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 7, 2016
• Study Start: March 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2020
• Last Updated: November 15, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

AZ (1)