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

NCT02135523 | Completed

• 1 other identifier: 4-2013-0896
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

• 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

Conditions

Ovarian Cancer (Epithelial)

Keywords

ovarian cancer; involved-field radiation therapy; progression free survival

Outcome Measures

Primary Outcomes (1)

• Two-year progression free survival(PFS) after involved-field 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.

  Participants will be followed for 2 year after radiation therapy

Secondary Outcomes (4)

• overall survival

  Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy

• chemotherapy-free survival

  Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy

• in-field disease control

  Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy

• serious adverse event

  Participants will be followed at 1, 3, 6, 12, 18 and 24 month after radiation therapy

Study Arms (1)

single arm: involved-field radiation therapy group

EXPERIMENTAL

Radiation: involved-field radiation therapy

Interventions

involved-field radiation therapy RADIATION

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.

single arm: involved-field radiation therapy group

Eligibility Criteria

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

You may qualify if:

• age\> 19 years
• ECOG performance status 0-1
• pathologically confirmed malignant epithelial ovarian cancer
• surgically removal of tumor including both ovary resection, total hysterectomy, lymph node and mesentery
• 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

You may not qualify if:

• diffuse peritoneal seeding
• brain or bone metastasis
• 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
• serious underlying medical disease
• not providing informed consent

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Severance Hospital

Seoul, Korea, 120-752, South Korea

Location

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2014
• First Posted: May 12, 2014
• Study Start: February 6, 2014
• Primary Completion: January 8, 2018
• Study Completion: January 8, 2018
• Last Updated: May 17, 2018

Record last verified: 2018-05

Locations

KR (1)