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Uterine Serous Carcinoma and Adjuvant Combined Intraperitoneal Chemotherapy and Radiation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04030000
Recruitment Status : Not yet recruiting
First Posted : July 23, 2019
Last Update Posted : March 16, 2020
Sponsor:
Information provided by (Responsible Party):
Karin Shih, Northwell Health

Brief Summary:

Uterine serous carcinoma (USC) is an uncommon, but aggressive variant of endometrial carcinoma that has poor response to standard therapy. After staging and surgery, radiation therapy and/or chemotherapy is recommended to treat patients at high risk for recurrence. In advanced stage and recurrent setting, high risk uterine cancer mirrors ovarian cancer with it spread patterns and response to therapy. Based on these findings and the similarities as well as the clinical success of paclitaxel with IP platinum therapy in patients with ovarian serous carcinoma, investigators propose to prospectively assess IV/IP therapy in patients with advanced stage and recurrent USC.

During Week 1-18, subjects will be placed on open-label IP Carboplatin/IV Paclitaxel on Day 1, then administered IP Paclitaxel on Day 8. This will be repeated every 3 weeks for 6 cycles. A CT imaging scan will be performed after six cycles of chemotherapy, prior to radiation. Also, in Week 19-23, subjects will receive Pelvic radiation therapy (IMRT) if deemed necessary. Additionally, from Week 24-26, High Dose Radiation or IMRT will be used where appropriate.

Patients will be monitored for toxicity and feasibility of the regimen. Secondary outcomes will include assessing the frequency and the reasons for early discontinuation of the study treatments as well as describing patient-reported quality of life parameters at specified time points during the study using validated questionnaires: EORTC QLQ-C30 and QLQ-OV28.


Condition or disease Intervention/treatment Phase
Uterine Carcinoma Drug: Paclitaxel/Carboplatin Radiation: Pelvic radiation therapy Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: During Week 1-18, subjects will be placed on open-label IP Carboplatin/IV Paclitaxel on Day 1, then administered IP Paclitaxel on Day 8. This will be repeated every 3 weeks for 6 cycles. A CT imaging scan will be performed after six cycles of chemotherapy, prior to radiation. Also, in Week 19-23, subjects will receive Pelvic radiation therapy (IMRT) if deemed necessary. Additionally, from Week 24-26, High Dose Radiation or IMRT will be used where appropriate.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Phase II Trial of Intravenous Paclitaxel and Intraperitoneal Carboplatin/Taxol Followed by Radiation in Patients With Advanced Stage Uterine Serous Carcinoma
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Paclitaxel/Carboplatin and radiation

Paclitaxel 135 mg/m2 over 3 hrs on day 1 Carboplatin IP (AUC= 6.0) on day 1 Paclitaxel 60 mg/m2 IP on Day 8 Repeat q 21 days x 6 cycles

Pelvic 6MV Photon Beam Energy, or IMRT where appropriate 1.8 Gy Dose/FX Total Dose 45 Gy

High Dose Radiation (HDR) x 3, or IMRT where appropriate 5 Gy to 0.5cm Depth from the Vaginal Cylinder Surface Total Dose 15 Gy

Drug: Paclitaxel/Carboplatin
IV paclitaxel in combination with IP carboplatin

Radiation: Pelvic radiation therapy
EBRT and vaginal brachytherapy




Primary Outcome Measures :
  1. Incidence of Treatment-related Adverse Events [ Time Frame: 2 years post diagnosis ]
    Number of patients with treatment-related adverse events as assessed by CTCAE v4.0

  2. Feasibility of above regimen in women with advanced stage USC [ Time Frame: 2 years post diagnosis ]
    Feasibility will be assessed by: Treatment completion proportion - the proportion of participants who complete the IV paclitaxel/IP carboplatin followed by IP paclitaxel/RT regimen Screening ratio - the number of potential participants screened per enrolled participant


Secondary Outcome Measures :
  1. Patient quality of life [ Time Frame: Baseline (after surgery, prior to initiating first cycle), Completion of chemotherapy (18 weeks after Cycle 1 Day 1),Completion of radiation therapy (26 weeks after Cycle 1 Day), Two years post diagnosis ]
    The questionnaires used are EORTC QLQ-C30. QOL will be assessed using the validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-c30) version 3.0. To date, more than 2200 studies using QLQ-C30 have been registered. This 30-item summary score captures the dimension of physical well-being, functional well-being, and symptom scales.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histological/cytologically documented primary FIGO Stage IIIA, IIIB, IIIC1, IIIC2, IVA and IVB uterine serous carcinoma. Patients with stage IVB disease include abdominal sites of metastasis only.
  2. All patients must have a procedure for determining the definitive diagnosis of USC. At the discretion of the surgeon, complete surgical staging should include: total hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, omental biopsy and lymph node evaluation.
  3. Residual disease at completion of surgery of ≤ 1cm by surgeon report.
  4. Age > 18 years.
  5. ECOG performance status of ≤ 2.
  6. Written voluntary informed consent.

Exclusion Criteria:

  1. Distant metastasis outside the abdominal cavity.
  2. Patient has impairment of hepatic, renal or hematologic function as defined by the following baseline laboratory values:

    1. Serum SGOT and /or SGPT > 2.5 times the institutional upper limit of normal (ULN)
    2. Total serum bilirubin > 1.5 mg/dl
    3. Serum creatinine > 2.0 mg/dl
    4. Platelets < 100,000/mm3
    5. Absolute neutrophil count (ANC) < 1500/mm3
    6. Hemoglobin < 8.0 g/dl (the patient may be transfused prior to study entry)
  3. History of abdominal/pelvic radiation therapy.
  4. Severe or uncontrolled, concurrent medical disease (e.g. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)
  5. Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04030000


Contacts
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Contact: Arisa Kapedani, MS 347-956-1695 akapedani@northwell.edu

Sponsors and Collaborators
Northwell Health
  Study Documents (Full-Text)

Documents provided by Karin Shih, Northwell Health:
Publications of Results:

Other Publications:
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Responsible Party: Karin Shih, Principal Investigator, Northwell Health
ClinicalTrials.gov Identifier: NCT04030000    
Other Study ID Numbers: USC
First Posted: July 23, 2019    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Carcinoma
Cystadenocarcinoma, Serous
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Cystadenocarcinoma
Adenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous
Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action