Study Details

Open

A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum

The purpose of this study is to test if a hormonal drug Letrozole used either by itself or by adding it to the usual combination of chemotherapy drugs can help lower the chance of your ovarian or peritoneal cancer from growing or spreading.

Age & Gender

18 years ~ 99 years
Female

Visit Availability

Standard business hours (M-F, 8-5)
Visits can be combined with regular clinical appointments

Location

North Carolina (Statewide)

What will be asked of you

This study aims to treat your cancer and closely resembles routine care that would be received regardless of participating on a research study. To participate on the study, you will frequently meet with a member of the study team in addition to your oncology care team. The study has 2 groups: group 1 (Carboplatin and paclitaxel for 6 cycles and then letrozole alone) and group 2 (Letrozole alone). The computer will randomly put you in a study group. The study involves blood collection; collection of your tissue sample from your biopsy or surgery; study treatment for 4 and half months; follow up 3 months for the first 2 years after treatment ; then every 6 months for three years, and then annually.

Incentives

In-person visits:
8-9

Total length of participation:
up to 10 years

Looking for Specific Volunteers

Able to participate:

you were recently diagnosed with Stage II-IV low-grade serous ovarian cancer
you are able to take oral medications
you have had surgery to remove both of your ovaries and fallopian tubes
you have had an attempt at surgery to remove your cancer
you are within ≤8 weeks of surgery to remove your cancer at time of entry into the study

Not eligible if:

you have received chemotherapy or radiation for the treatment of your ovarian cancer
you have already received hormonal therapy for the treatment of your ovaian cancer
you have severe heart disease
you have active infection that is not controlled with treatment
you have neuropathy that impacts your ability to complete routine household tasks or care for yourself

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Linda Van Le
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Ovarian)

IRB Number

19-3183

ClinicalTrials.gov

NCT04095364