Early Phase 1 Ovarian Cancer Trial, Recruiting NCT05415709 Sponsor: Ohio State University Comprehensive Cancer Center Condition: Ovarian Cancer
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Early Phase 1 Ovarian Cancer Trial, Recruiting

NCT05415709
Recruiting Early Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You must be able to understand English and be willing to sign a consent form agreeing to take part
  • You must be 18 years of age or older
  • You must have been recently diagnosed with stage III or IV ovarian, fallopian tube, or peritoneal cancer (of a specific type: serous, mucinous, or endometrioid), confirmed through a tissue sample, biopsy, or certain fluid/cell tests meeting specific criteria (confirm with trial site)
  • Your doctors must have decided that major surgery to remove the cancer upfront was not possible, and you are planned for or already receiving chemotherapy before surgery (called neoadjuvant chemotherapy)
  • You must be planned to have surgery to remove as much cancer as possible after 3–4 rounds of chemotherapy
  • You must have completed three rounds of a standard chemotherapy combination (carboplatin and paclitaxel, given every 3 weeks)
  • Your cancer must have responded to chemotherapy — either shrinking or a significant drop (at least 50%) in a blood marker called CA-125
  • You must be considered healthy enough for major surgery (a low-to-moderate anaesthetic risk level)
  • You must have a good general level of physical functioning, able to carry out daily activities (confirm with trial site)
  • Your kidney function must be within an acceptable range, based on blood tests
  • Your blood cell counts (white blood cells, infection-fighting cells, and platelets) must be within acceptable levels
  • Your liver function blood tests must be within acceptable levels
  • You must complete a quality-of-life questionnaire before being assigned to a treatment group

Who may not be able to join:

  • You have a history of breast cancer or any other cancer diagnosed within the last 5 years (minor skin cancers or a very early-stage cervical condition may be exceptions — confirm with trial site)
  • Your ovarian cancer is of a low-grade or borderline type
  • You have a history of or currently have inflammatory bowel disease (a long-term condition causing inflammation in the digestive tract)
  • You have had an allergic reaction to cisplatin, carboplatin, paclitaxel, or similar medicines in the past
  • You have a serious uncontrolled illness, such as an active infection, heart failure, unstable chest pain, or an irregular heartbeat
  • If during surgery it is found that complete or near-complete removal of the cancer is not possible, you would not be able to continue in the trial at that point

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 8 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: Floor Backes, MD, Ohio State University Comprehensive Cancer Center

Phone: 800-293-5066

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Early Phase 1
Sponsor
Ohio State University Comprehensive Cancer Center
Registry
ClinicalTrials.gov
Start date
13 June 2022
Est. completion
31 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Incidence of chemotherapy-related adverse events

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov