August 1, 2022 Gynecology

Protocol: NRG – GY019

SCHEMA NRG GY019

Please Note: Below is partial eligibility, for full eligibility requirement’s, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!

Eligibility:

  1. Patients must have newly diagnosed, Stage II-IV low-grade serous ovarian cancer (submission of pathology report(s) required). Ovarian cancer = ovarian, fallopian tube
    and primary peritoneal cancers. p53 immunohistochemistry (IHC) is required and must show nonaberrant pattern (nonaberrant p53 expression is consistent with normal/wildtype TP53). If aberrant p53 expression is found on p53 IHC, the patient is NOT eligible (aberrant p53 expression is consistent with mutant TP53 and supports diagnosis of high grade serous ovarian cancer).
  2. History/physical examination within 14 days prior to registration.
  3. Contrast-enhanced Imaging of the chest, abdomen and pelvis within 28 days prior to registration.
  4. Age ≥ 18.
  5. Patients must have undergone an attempt at maximal upfront cytoreductive surgery, with either optimal (<=1cm diameter residual disease/nodule) or suboptimal residual disease (>1 cm diameter residual disease/nodule) status allowed.
  6. Patients must have undergone a bilateral salpingo-oophorectomy.
  7. ECOG Performance Status of 0, 1 or 2.
  8. Patients must be able to take per oral (P.O.) medications.
  9. Patients must be within ≤8 weeks of primary cytoreductive surgery at time of randomization.

Ineligibility:

  1. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the
    investigational regimen are eligible for this trial.
  2. Patients may not have received neoadjuvant chemotherapy or radiotherapy for the treatment of this disease.
  3. Patients may not have received previous hormonal therapy for the treatment of this disease.
  4. Patients with ≥grade 2 baseline neuropathy.
  5. Patients with active (except for uncomplicated urinary tract infection) or uncontrolled systemic infection.

 



February 18, 2021 Gynecology

Protocol: NRG – GY018

SCHEMA NRG GY018

Please Note: Below is partial eligibility, for full eligibility requirement’s,  please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 and/or (810) 762-8038. Thank you!

Eligibility:

  1. Histologic confirmation of the original primary tumor is required (submission of pathology report(s) is required). Patients with the following histologic types are eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, dedifferentiated/undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified.
  2. Pathology report showing results of institutional MMR IHC testing.
  3. Measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial cancer.
  4. Patients may have received, prior chemotherapy for treatment of endometrial cancer OR  Prior adjuvant chemotherapy (e.g., paclitaxel/carboplatin alone or as a component of concurrent chemotherapy and radiation therapy [with or without cisplatin]) provided adjuvant chemotherapy was completed ≥ 12 months prior registration.
  5. Patients may have received prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para aortic radiation therapy, intravaginal brachytherapy, and/or palliative radiation therapy.
  6. At least 18 years of age.
  7. ECOG Performance Status 0-2
  8. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

Ineligibility:

  1. Patients with prior treatment with anti-PD-1, anti-PD-L1 or anti-CTLA-4 therapeutic antibody or other similar agents.
  2. Patients who are currently participating and receiving cancer-directed study therapy or have participated in a study of an investigational agent and received cancer-directed study therapy within 4 weeks prior to  registration.
  3. Patients who have a diagnosis of immunodeficiency or are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to registration.
  4. Patients with treated brain metastases are eligible if follow-up brain imaging after CNSdirected therapy shows no evidence of progression, and they have been off steroids for at least 4 weeks prior to Step registration and remain clinically stable.


February 18, 2021 Gynecology

Protocol: NRG – GY019

Please Note: Below is a partial list of eligibility, please contact GHCI Research Department at (810) 762-8181, (810) 762-8079 or (810) 762-8038 to discuss full eligibility requirements.

Eligibility:

SCHEMA NRG-GY019

  1. Patients must have newly diagnosed, Stage II-IV low-grade serous ovarian cancer (submission of pathology report(s) required). Ovarian cancer = ovarian, fallopian tube and primary peritoneal cancers. p53 immunohistochemistry (IHC) is required and must show nonaberrant pattern (nonaberrant p53 expression is consistent with normal/wildtype TP53). If aberrant p53 expression is found on p53 IHC, the patient is NOT eligible (aberrant p53 expression is consistent with mutant TP53 and supports diagnosis of high grade serous ovarian cancer).
  2. Must be at least 18 years of age.
  3. Patients must have undergone an attempt at maximal upfront cytoreductive surgery, with either optimal (<=1cm diameter residual disease/nodule) or suboptimal residual disease (>1 cm diameter residual disease/nodule) status allowed.
  4. Patients must have undergone a bilateral salpingo-oophorectomy.
  5. ECOG Performance Status 0-2
  6. Patients must be within ≤8 weeks of primary cytoreductive surgery at time of randomization.
  7. Patients must be able to take per oral (P.O.) medications.

Ineligibility:

  1. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  2. Patients may not have received neoadjuvant chemotherapy or radiotherapy for the treatment of this disease.
  3. Patients may not have received previous hormonal therapy for the treatment of this disease.

 


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