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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

Brief Summary:
Definitive treatment protocol for high-dose intensity-modulated radiotherapy (IMRT) with intracavitary radiotherapy in locally advanced cervical cancer: A phase II trial

Condition or disease Intervention/treatment Phase
Radiation Radiation: High-dose Intensity-modulated radiotherapy Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Definitive Treatment Protocol for High-dose Intensity-modulated Radiotherapy (IMRT) With Intracavitary Radiotherapy in Locally Advanced Cervical Cancer: A Phase II Trial
Study Start Date : January 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Arm Intervention/treatment
Experimental: Intensity-modulated radiotheapy arm
Intensity-modulated radiotheapy with stereotactic boost or intracavitary radiotherapy
Radiation: High-dose Intensity-modulated radiotherapy
Pelvic High-dose Intensity-modulated radiotherapy with stereotactic radiotherapy or intracavitary radiotherapy




Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 30 months ]
    Progression means locoregional recurrence, distant metastasis, and local tumor pregression


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 30 months ]
  2. Treatment-related adverse events are assessed by CTCAE v4.0. [ Time Frame: acute within 3 months and chronic after 3 months after radiotherapy ]
    Toxicity



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993653


Contacts
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Contact: Jong Hoon Lee, MD +82-010-8607-1269 koppul@catholic.ac.kr

Locations
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Korea, Republic of
Lee Jong Hoon Recruiting
Suwon, Korea, Republic of
Contact: Jong Hoon Lee       koppul@catholic.ac.kr   
Sponsors and Collaborators
Seoul St. Mary's Hospital
Investigators
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Principal Investigator: Jong Hoon Lee, MD St. Vincent's Hospital, South Korea

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Responsible Party: Jong Hoon Lee, Professor, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT02993653     History of Changes
Other Study ID Numbers: VINPI1501
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: December 15, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No