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

• ClinicalTrials.gov Identifier: NCT02957266
• Recruitment Status: Unknown
• First Posted: November 6, 2016
• Last Update Posted: November 15, 2016
• Sponsor: The National Center of Oncology, Azerbaijan
• Information provided by (Responsible Party): Kamal Akbarov, The National Center of Oncology, Azerbaijan

Tracking Information

• First Submitted Date: November 3, 2016
• First Posted Date: November 6, 2016
• Last Update Posted Date: November 15, 2016
• Study Start Date: March 2015
• Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 3, 2016): Relapse Rate (local and/or distant) and Number of Deaths Due to Any Cause [ Time Frame: 4 years ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 14, 2016)

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

Original Secondary Outcome Measures (submitted: November 3, 2016)

• 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 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Cervical Cancer

Intervention

• Radiation: Volumetric Arc Radiotherapy
  Volumetric Arc Radiotherapy
• Radiation: Interstitial brachytherapy
  Interstitial High Dose Rate Brachytherapy
• Drug: Cisplatin
  Weekly Cisplatin
  Other Name: CDDP
• Drug: Gemcitabine
  Weekly Gemcitabine
  Other Name: Gemcitabine Hydrochloride
• Genetic: PIK3CA
  PIK3CA mutations rate
• Genetic: KRAS
  KRAS mutations rate
• Genetic: BRAF
  BRAF mutations rate
• Genetic: RRM1
  RRM1 mutations rate

Study Arms

• Active Comparator: Classical treatment
  Classical concurrent cisplatin based chemoradiotherapy of cervical cancer. PIK3CA, KRAS, BRAF and RRM1 mutations rates.
  Interventions:

  • Radiation: Volumetric Arc Radiotherapy
  • Drug: Cisplatin
  • Genetic: PIK3CA
  • Genetic: KRAS
  • Genetic: BRAF
  • Genetic: RRM1
• Experimental: GemInterBraVMAT

  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.

  Interventions:

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 3, 2016): 400
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2020
• Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Azerbaijan

Administrative Information

• NCT Number: NCT02957266
• Other Study ID Numbers: MOM-0001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Kamal Akbarov, The National Center of Oncology, Azerbaijan
• Original Responsible Party: Same as current
• Current Study Sponsor: The National Center of Oncology, Azerbaijan
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Kamal Akbarov, PhD; National Center of Oncology

• PRS Account: The National Center of Oncology, Azerbaijan
• Verification Date: November 2016