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

Yonsei University

Status and phase: Unknown; Phase 2

Conditions: Recurrent Ovarian Cancer

Treatments: Radiation: Involved-field radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03618706

4-2018-0299

Details and patient eligibility

About

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).

Enrollment: 107 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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107 participants in 1 patient group

involved-field RT + standard salvage treatment

Experimental group

Description:

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

Treatment:

Radiation: Involved-field radiotherapy