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Intensity-modulated Radiotherapy Protocol in Cervix Cancer

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ClinicalTrials.gov Identifier: NCT02993653
Recruitment Status : Unknown
Verified December 2016 by Jong Hoon Lee, Seoul St. Mary's Hospital.
Recruitment status was:  Recruiting
First Posted : December 15, 2016
Last Update Posted : December 15, 2016
Sponsor:
Information provided by (Responsible Party):
Jong Hoon Lee, Seoul St. Mary's Hospital

Tracking Information
First Submitted Date  ICMJE December 11, 2016
First Posted Date  ICMJE December 15, 2016
Last Update Posted Date December 15, 2016
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2016)
Progression-free survival [ Time Frame: 30 months ]
Progression means locoregional recurrence, distant metastasis, and local tumor pregression
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2016)
  • Overall survival [ Time Frame: 30 months ]
  • Treatment-related adverse events are assessed by CTCAE v4.0. [ Time Frame: acute within 3 months and chronic after 3 months after radiotherapy ]
    Toxicity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intensity-modulated Radiotherapy Protocol in Cervix Cancer
Official Title  ICMJE Definitive Treatment Protocol for High-dose Intensity-modulated Radiotherapy (IMRT) With Intracavitary Radiotherapy in Locally Advanced Cervical Cancer: A Phase II Trial
Brief Summary Definitive treatment protocol for high-dose intensity-modulated radiotherapy (IMRT) with intracavitary radiotherapy in locally advanced cervical cancer: A phase II trial
Detailed Description

Radiotherapy

  1. intensity-modulated radiotherapy of whole pelvis: 60 Gy in 30 fx Re-simulation with pelvic Magnetic resonance imaging at 46 Gy in 23 fx and intensity-modulated radiotherapy on the gross cervical and nodal tumor (initially Positron emission tomography-positive), 14 Gy in 7 fx
  2. intensity-modulated radiotherapy boost of gross cervical tumor or Intra-cavitary radiotherapy (ICR)

    • Re-staging pelvic Magnetic resonance imaging , if complete response occurs Intra-cavitary radiotherapy to A point, 25 Gy in 5 fx for 2 weeks
    • Re-staging pelvic Magnetic resonance imaging I, partial response or stable disease occurs intensity-modulated radiotherapy boost , 10 Gy in 4 fx to the gross cervical tumor for 1 week
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Radiation
Intervention  ICMJE Radiation: High-dose Intensity-modulated radiotherapy
Pelvic High-dose Intensity-modulated radiotherapy with stereotactic radiotherapy or intracavitary radiotherapy
Study Arms  ICMJE Experimental: Intensity-modulated radiotheapy arm
Intensity-modulated radiotheapy with stereotactic boost or intracavitary radiotherapy
Intervention: Radiation: High-dose Intensity-modulated radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 14, 2016)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2018
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. FIGO II-IVA Patients with untreated and histologically confirmed carcinoma of the uterine cervix
  2. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1
  3. Patients with adequate bone marrow function: Absolute nutrophil count (ANC) greater than or equal to 1,500/mcl, platelets greater than or equal to 100,000/mcl at the beginning
  4. Patients with adequate renal function: creatinine equal to or less than 2.0 mg/mL
  5. Patients who have signed an approved informed consent and authorization

Exclusion Criteria:

  1. Patients with recurrent cervical cancer
  2. Patients who have diagnosis of other malignance tumors except papillary or follicular thyroid cancer or skin cancer
  3. Patients with metastatic lymphadenopathies other than pelvis (e.g. inguinal, paraaortic, supraclavicular, or mediastinal node)
  4. Patients with distant organ metastasis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02993653
Other Study ID Numbers  ICMJE VINPI1501
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jong Hoon Lee, Seoul St. Mary's Hospital
Study Sponsor  ICMJE Seoul St. Mary's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jong Hoon Lee, MD St. Vincent's Hospital, South Korea
PRS Account Seoul St. Mary's Hospital
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP