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

NCT03618706 | Unknown Phase 2

• 1 other identifier: 4-2018-0299
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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).

Conditions

Recurrent Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

• 2-year progression-free survival (PFS)

  2 years after radiotherapy

Secondary Outcomes (4)

• Local control of recurred lesions

  2 years after radiotherapy

• Any other new recurrence events

  2 years after radiotherapy

• Radiotherapy-related complications

  2 years after radiotherapy

• Chemotherapy-free interval (The interval to delay the need for a new chemotherapy regimen for disease progression)

  2 years after radiotherapy

Study Arms (1)

involved-field RT + standard salvage treatment

EXPERIMENTAL

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

Radiation: Involved-field radiotherapy

Interventions

Involved-field radiotherapy 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.

involved-field RT + standard salvage treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, Korea, 120-752, South Korea

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Yong Bae Kim, MD, PhD

CONTACT

82-2228-8095; ybkim3@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: August 7, 2018
• Study Start: May 10, 2018
• Primary Completion: May 9, 2023
• Study Completion: May 9, 2023
• Last Updated: August 7, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)