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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

Study Description
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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).

Condition or disease Intervention/treatment Phase
Recurrent Ovarian Cancer Radiation: Involved-field radiotherapy Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 107 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Standard of Care Therapy With Involved Field Radiation Therapy for Selective Recurrent Ovarian Cancer
Actual Study Start Date : May 10, 2018
Estimated Primary Completion Date : May 9, 2023
Estimated Study Completion Date : May 9, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: involved-field RT + standard salvage treatment
Patients receiving involved-field RT on recurred lesions + standard salvage treatment for recurrent ovarian cancer
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 2-year progression-free survival (PFS) [ Time Frame: 2 years after radiotherapy ]

Secondary Outcome Measures :
  1. Local control of recurred lesions [ Time Frame: 2 years after radiotherapy ]
  2. Any other new recurrence events [ Time Frame: 2 years after radiotherapy ]
  3. Radiotherapy-related complications [ Time Frame: 2 years after radiotherapy ]
  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT03618706


Contacts
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Contact: Yong Bae Kim, MD, PhD 82-2228-8095 ybkim3@yuhs.ac

Locations
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Korea, Republic of
Severance Hospital Recruiting
Seoul, Korea, Korea, Republic of, 120-752
Contact: YongBae Kim, MD    82-10-6256-2592    ybkim3@yuhs.ac   
Sponsors and Collaborators
Yonsei University
More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03618706    
Other Study ID Numbers: 4-2018-0299
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
 Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type