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

NCT ID: NCT03618706

Last Updated: 2018-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-10

Study Completion Date

2023-05-09

Brief Summary

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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

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Conditions

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Recurrent Ovarian Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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involved-field RT + standard salvage treatment

Patients receiving involved-field RT on recurred lesions + standard salvage treatment for recurrent ovarian cancer

Group Type EXPERIMENTAL

Involved-field radiotherapy

Intervention Type RADIATION

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.

Interventions

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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.

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Hospital

Seoul, Korea, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yong Bae Kim, MD, PhD

Role: CONTACT

82-2228-8095

Facility Contacts

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YongBae Kim, MD

Role: primary

82-10-6256-2592

Other Identifiers

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4-2018-0299

Identifier Type: -

Identifier Source: org_study_id

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