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Effect of Chemotherapy on Homologous Recombination Repair Ability

Effect of Neoadjuvant Chemotherapy on Homologous Recombination Repair Ability in Epithelial Ovarian Cancer - JIKEI P-HDR Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000049833
Enrollment
35
Registered
2023-04-01
Start date
2023-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ovarian carcinoma, tubal carcinoma, peritoneal carcinoma

Interventions

None listed

Sponsors

The Jikei University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: (1) Patients with histopathologically diagnosed ovarian cancer, fallopian tube cancer, or peritoneal cancer. (2) Patients diagnosed as advanced stage III or IV by initial surgery (diagnostic laparoscopy or laparotomy), CT or MRI scan, and judged to be unable to undergo primary debulking surgery. (3) Patients with evaluable lesions (4) Age between 18 and 80 years old (5) PS (ECOG) 0 or 1 (6) Patients who have given written informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with contraindications to either paclitaxel or carboplatin. (2) Patients with poorly controlled cardiac disease, renal disease, or diabetes mellitus. (3) Patients with interstitial pneumonia or pulmonary fibrosis (to be confirmed by CT scan). (4) Patients with intestinal paralysis or intestinal obstruction that is poorly controlled. (5) Patients with infectious diseases requiring treatment. (6) Patients with a history of radiation therapy to the chest or abdomen. (7) Patients with active multiple cancers (not including intraepithelial cancer). (viii) Patients with a history of serious drug hypersensitivity. (9) Patients with symptomatic central nervous system metastasis. (10) Patients who are pregnant or lactating. (11) Patients who are currently receiving or have recently received other investigational drugs (including unapproved drugs). (12) Patients who are judged to be inappropriate to participate in this study by the investigators or co-investigators.

Design outcomes

Primary

MeasureTime frame
Percentage change in GIS score with preoperative chemotherapy

Secondary

MeasureTime frame
Response rate to chemotherapy before IDS

Countries

Japan

Contacts

Public ContactNozomu Yanaihara

The Jikei University Obstetrics and Gynecology

jikei.obgyn.tjmp@jikei.ac.jp0334331111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026