Research & Innovation

Ovarian Clinical Trials

Clinical Trials

Gradalis CL-PTL-135

Physician & Study Coordinator

Study Coordinator

Janine Schippang
email: JanineL.Schippang@sluhn.org
phone: 484-658-1790

 

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Synopsis

Blood and Tissue Procurement Protocol for Product Development and Research.

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Eligibility Criteria
  • Patients must agree to collection of blood and/or tumor tissue/fluid that is obtained during a standard of care procedure or visit (as of 5/11/23 - no blood collection is necessary unless specifically requested by sponsor)
  • For Ovarian cancer - fresh tissue collection of frontline, newly diagnosed, treatment naive, Stage IIIb or IV or first recurrenct, platinum-sensitive tumors (tissue collection must occur prior to initiation of any systemic therapy for recurrence)
  • For Ovarian cancer - fluid collection from first tap of ascited or pleural fluid of first recurrence, platinum-sensitive tumors (can be collected prior to or after systemic therapy for recurrence is initiated)

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NRG-GY019

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 (NCT 04095364).

Physician & Study Coordinator

Study Coordinator

Janine Schippang
email: JanineL.Schippang@sluhn.org
phone: 484-658-1790

 

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Synopsis

This study is being done to help determine if the use of a hormonal therapy drug, Letrozole, used either by itself or in combination with chemotherapy, will lower the chance of ovarian or peritoneal cancer growing or spreading. The use of Letrozole without chemotherapy may shrink or stabilize the cancer in the same way that chemotherapy also does, but without the added side effects of chemotherapy. Letrozole is an aromatase inhibitor, which indirectly stops the body from producing estrogen.

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Eligibility Criteria

Your doctor will determine whether this clinical trial is an appropriate option for you. Some key eligibility criteria are as follows:

  • Newly diagnosed stage II-IV low-grade serous ovarian cancer that shows a nonaberrant pattern p53 by immunohistochemistry
  • Patients must have undergone an attempt at maximal upfront cytoreductive surgery, with either optimal or suboptimal residual disease status
  • Patients must be within ≤8 weeks of primary cytoreductive surgery at the time of study randomization
  • Patients must be able to take oral pills
  • Patients may not have had prior neoadjuvant or adjuvant chemotherapy or radiotherapy for treatment of this disease
  • Patients may not have received prior hormonal therapy for treatment of this disease

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