Trial of Cisplatin Plus Radiation Followed by Carbo and Taxol Vs. Sandwich Therapy of Carbo and Taxol Followed Radiation Then Further Carbo and Taxol

  • STATUS
    Recruiting
  • End date
    Mar 23, 2023
  • participants needed
    450
  • sponsor
    Women's Cancer Care Associates, LLC
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Updated on 23 January 2021
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Investigator
Joyce N Barlin, MD
Primary Contact
Greater Baltimore Medical Center (9.3 mi away) Contact
+6 other location
platelet count
paclitaxel
hysterectomy
absolute neutrophil count
carboplatin
taxol
endometrial carcinoma
lymph node sampling

Summary

To determine if treatment with cisplatin and radiation followed by carbo and taxol reduces the rate of recurrence when compared to sandwich therapy.

Description

To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of recurrence (increases recurrence-free survival) when compared to sandwich therapy (control arm).

To determine if treatment with cisplatin and volume-directed radiation followed by carboplatin and paclitaxel for 4 cycles (experimental arm) reduces the rate of death (increases survival) when compared to sandwich therapy (control arm).

To compare the regimens with respect to tolerability and acute and late adverse effects of therapy.

Details
Treatment radiation therapy, cisplatin, carboplatin, Paclitaxel
Clinical Study IdentifierNCT02501954
SponsorWomen's Cancer Care Associates, LLC
Last Modified on23 January 2021

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have any of these conditions: Stage IIIB Uterine Corpus Cancer or Stage IVA Uterine Corpus Cancer or Endometrial Serous Adenocarcinoma or Stage IIIA Uterine Corpus Cancer or Endome...?
Do you have any of these conditions: Stage IIIC Uterine Corpus Cancer or Stage IIIB Uterine Corpus Cancer or Stage IIIA Uterine Corpus Cancer or Endometrial Clear Cell Adenocarcinoma or E...?
All patients with Surgical Stage III or IVA endometrial carcinoma per FIGO 2009 staging criteria, including clear cell and serous papillary and undifferentiated carcinomas
Surgical Stage III disease includes those patients with positive adnexa, parametrial involvement, tumor invading the serosa, positive pelvic and/or para-aortic nodes, or vaginal involvement
Surgical Stage IVA includes patients with bladder or bowel mucosal involvement, but no spread outside the pelvis
Patients with FIGO 2009 surgical Stage I or II endometrial clear cell or serous carcinoma and with positive peritoneal cytology
Surgery must have included a hysterectomy and bilateral salpingooophorectomy. Pelvic lymph node sampling and para-aortic lymph node sampling are optional
Patients with a GOG Performance Status of 0, 1, or 2
Patients with adequate organ function, reflected by the following parameters
WBC 3000/mcl Absolute neutrophil count (ANC) 1500/mcl Platelet count
000/mcl SGOT, SGPT, and alkaline phosphatase 2.5 X upper limit of normal
(ULN) Bilirubin 1.5 X ULN Creatinine institutional ULN
Patients must be 18 years of age or older
Entry into the study is limited to no more than 8 weeks from the date of surgery

Exclusion Criteria

Patients with carcinosarcoma
Patients with recurrent endometrial cancer
Patients with residual tumor after surgery (any single site) exceeding 1 cm in maximum dimension
Patients who have had pelvic or abdominal radiation therapy
Patients with positive pelvic washings as the only extra-uterine disease are NOT eligible if the histology is other than clear cell or papillary serous carcinoma
Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of active malignancy within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
Patients with a history of serious co-morbid illness or uncontrolled illnesses that would preclude protocol therapy
Patients with an estimated survival of less than three months
Patients with FIGO 2009 Stage IVB endometrial cancer
Patients with parenchymal liver metastases
Patients who have received prior chemotherapy for endometrial cancer
Patients with a history of myocardial infarction, unstable angina, or uncontrolled arrhythmia within 3 months from enrollment
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