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Standard of Care Therapy With Involved Field Radiation Therapy for Selective Recurrent Ovarian Cancer

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ClinicalTrials.gov Identifier: NCT03618706
Recruitment Status : Recruiting
First Posted : August 7, 2018
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Tracking Information
First Submitted Date  ICMJE July 9, 2018
First Posted Date  ICMJE August 7, 2018
Last Update Posted Date August 7, 2018
Actual Study Start Date  ICMJE May 10, 2018
Estimated Primary Completion Date May 9, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
2-year progression-free survival (PFS) [ Time Frame: 2 years after radiotherapy ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2018)
  • Local control of recurred lesions [ Time Frame: 2 years after radiotherapy ]
  • Any other new recurrence events [ Time Frame: 2 years after radiotherapy ]
  • Radiotherapy-related complications [ Time Frame: 2 years after radiotherapy ]
  • Chemotherapy-free interval (The interval to delay the need for a new chemotherapy regimen for disease progression) [ Time Frame: 2 years after radiotherapy ]
    It means the interval between the last date performing the previous chemotherapy (before the start of involved-field radiotherapy) and the first date performing the new regimen of chemotherapy (for the disease failures after the involve-field radiotherapy). We want to measure this interval because we want to check the capability of involved-field radiotherapy to delay the need for the new regimen of chemotherapy for the progressive diseases.
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 Standard of Care Therapy With Involved Field Radiation Therapy for Selective Recurrent Ovarian Cancer
Official Title  ICMJE A Phase II Trial of Standard of Care Therapy With Involved Field Radiation Therapy for Selective Recurrent Ovarian Cancer
Brief Summary This study aims to investigate the effect of involved-field radiotherapy for recurrent ovarian cancer after primary standard treatment. We will investigate whether the addition of involved-field RT improves 2-year PFS in those patients than that of historical data (only with other standard salvage treatments as systemic chemotherapy ± maximum tumor resection).
Detailed Description Not Provided
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 Recurrent Ovarian Cancer
Intervention  ICMJE Radiation: Involved-field radiotherapy
After the diagnosis of recurrences, patients will receive involved-field radiotherapy (gross tumor volume + margin) with any radiation dose scheme (≥45 Gy Biological Equivalent dose) as physician's discretion.
Study Arms  ICMJE Experimental: involved-field RT + standard salvage treatment
Patients receiving involved-field RT on recurred lesions + standard salvage treatment for recurrent ovarian cancer
Intervention: Radiation: Involved-field 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 1, 2018)
107
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 9, 2023
Estimated Primary Completion Date May 9, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pathologically confirmed ovarian carcinoma
  • Patients who received "standard treatment" for each stage as a primary treatment
  • No. of recurrent lesions:

If, all in lung, or intra-abdominal or pelvis organs - ≤ 5 If, any in liver, bone, or spinal cord - ≤ 2

  • Size of recurrent lesions ≤5 cm
  • All recurrent lesions are available for involved-field radiotherapy
  • Within 60 days before enrollment:
  • Absolute neutrophil count ANC ≥ 500 / mm3
  • Platelet ≥ 50,000 / mm3
  • Hb ≥ 8.0 g / dl
  • Good performance status (ECOG 0-1)

Exclusion Criteria:

  • Brain metastasis
  • Diffuse peritoneal carcinomatosis
  • Malignant pleural effusion
  • History of previous salvage radiotherapy for recurrent lesions
  • History of other malignancy or severe/unstable medical condition
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yong Bae Kim, MD, PhD 82-2228-8095 ybkim3@yuhs.ac
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03618706
Other Study ID Numbers  ICMJE 4-2018-0299
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yonsei University
Study Sponsor  ICMJE Yonsei University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yonsei University
Verification Date July 2018

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