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The Efficacy of Involved-field Radiation Therapy for Residual or Locoregionally Recurrent Epithelial Ovarian Cancer After Definitive Treatment; Multi-institutional Clinical Trial

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ClinicalTrials.gov Identifier: NCT02135523
Recruitment Status : Completed
First Posted : May 12, 2014
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
  1. Title: The efficacy of involved-field radiation therapy for residual or locoregionally recurrent epithelial ovarian cancer after definitive treatment; Multi-institutional phase 2 clinical trial
  2. Study period: 2014.04~2018.04
  3. Objective: To determine whether involved-field radiation therapy will prove to be improve 2-year progression free survival for residual or locoregionally recurrent epithelial ovarian cancer patients after definitive treatment.
  4. Patient Selection: primary epithelial ovarian cancer (Required sample size: 70)
  5. Planned number of patients

    • YUHS database have 149 FIGO stage III patients treated with debulking surgery and adjuvant platinum-based chemotherapy 2.
    • Of these patients, 90 patients experienced locoregional failures, and then the investigators selected 44 patients who could be treated effectively with IFRT based on MDACC suggestion.
    • Median interval to failure was 9 months in these patients

      • Hypothesis; IFRT reduces 44% hazard of progression compared with patients without IFRT
      • Sample size; two-sided, accrual time = 24 mo, f/u time= 36 mo. α= 0.05, power = 0.80 Null progression-free median survival = 9 mo Alt progression-free median survival = 16 mo Calculated sample number = total 27 patients Drop rate = 10% • Total sample number = 30 patients Estimated Enrollment : 30 participants

Drop rate = 10%

  • Total sample number = 70 patients 6. Radiation therapy: Participants will receive involved-field radiotherapy (external beam radiotherapy or brachytherapy) over 45Gy with 1.8-2.0 Gy fraction, five times per week for residual or locoregionally recurrent epithelial ovarian cancer after definitive treatment
  • Target volume

    • directed to gross disease plus a high-risk clinical target volume (CTV) that included the postoperative bed or the prechemotherapy extent of disease with a 1- to 1.5-cm margin, excluding uninvolved clinical structures
    • Additional CTVs were designated according to the risks of microscopic disease spread, proximity to critical structures, and other risk factors for complications.
    • Nodal CTVs included grossly involved lymph node sites, extending to cover adjacent uninvolved regions.
  • Modality; 3-dimensional conformal RT including electron, intensity-modulated RT, proton beam RT 7. Patient assessment: Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy 8. Key words: ovarian cancer, involved-field radiation therapy, progression free survival

Condition or disease Intervention/treatment Phase
Ovarian Cancer (Epithelial) Radiation: involved-field radiation therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : February 6, 2014
Actual Primary Completion Date : January 8, 2018
Actual Study Completion Date : January 8, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: single arm: involved-field radiation therapy group Radiation: involved-field radiation therapy
Participants will receive involved-field radiotherapy (external beam radiotherapy or brachytherapy) over 45Gy for residual or locoregionally recurrent epithelial ovarian cancer after definitive treatment. Patients will be treated with 1.8-2.0Gy fraction, five times per week. It starts 2 weeks later of chemotherapy.




Primary Outcome Measures :
  1. Two-year progression free survival(PFS) after involved-field radiation therapy [ Time Frame: Participants will be followed for 2 year after radiation therapy ]
    To determine whether involved-field radiation therapy will prove to be improved 2-year progression free survival for residual or locoregionally recurrent epithelial ovarian cancer patients after definitive treatment.


Secondary Outcome Measures :
  1. overall survival [ Time Frame: Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy ]
  2. chemotherapy-free survival [ Time Frame: Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy ]
  3. in-field disease control [ Time Frame: Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy ]
  4. serious adverse event [ Time Frame: Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy ]


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

Inclusion Criteria:

  1. age> 19 years
  2. ECOG performance status 0-1
  3. pathologically confirmed malignant epithelial ovarian cancer
  4. surgically removal of tumor including both ovary resection, total hysterectomy, lymph node and mesentery
  5. at least on of the following: consolidation therapy for grossly negative condition prior large tumor after surgery and adjuvant chemotherapy, residual tumor after adjuvant or salvage chemotherapy, local recurrent tumor after adjuvant or salvage chemotherapy, consolidation therapy after surgical removal of recurrent tumor

Exclusion Criteria:

  1. diffuse peritoneal seeding
  2. brain or bone metastasis
  3. prior invasive malignancy (except controlled skin cancer, carcinoma in situ of the cervix and early thyroid and gastric cancer) unless disease free for a minimum of 5 years prior to study entry
  4. serious underlying medical disease
  5. not providing informed consent

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): NCT02135523


Locations
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Korea, Republic of
Severance Hospital
Seoul, Korea, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02135523    
Other Study ID Numbers: 4-2013-0896
First Posted: May 12, 2014    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Keywords provided by Yonsei University:
ovarian cancer
involved-field radiation therapy
progression free survival
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