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

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ClinicalTrials.gov Identifier: NCT02501954
Recruitment Status : Recruiting
First Posted : July 17, 2015
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Joyce N. Barlin, MD, Women's Cancer Care Associates, LLC

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

Condition or disease Intervention/treatment Phase
Endometrial Clear Cell Adenocarcinoma Endometrial Serous Adenocarcinoma Stage IIIA Uterine Corpus Cancer Stage IIIB Uterine Corpus Cancer Stage IIIC Uterine Corpus Cancer Stage IVA Uterine Corpus Cancer Drug: Cisplatin Drug: Carboplatin Drug: Paclitaxel Radiation: Radiation Therapy Phase 3

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel Vs. Sandwich Therapy of Carboplatin and Paclitaxel Followed by Tumor Volume Directed Irradiation Then Further Carboplatin and Paclitaxel
Study Start Date : March 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Regimen I
Cisplatin 50 mg/m2 IV Days 1 and 29 plus Volume-directed radiation therapy followed by Carboplatin AUC 5 or 6 plus Paclitaxel 175 mg/m2 q 21 days for 4 cycles
Drug: Cisplatin
Given IV
Other Name: Platinol

Drug: Carboplatin
Given IV
Other Name: Paraplatin

Drug: Paclitaxel
Given IV
Other Name: Taxol

Radiation: Radiation Therapy
Undergo Radiation Therapy
Other Names:
  • RT
  • Irradiation

Active Comparator: Regimen II
Carboplatin AUC 6 plus Paclitaxel 175 mg/m2 q 21 days for 3 cycles followed by Volume-directed radiation therapy followed by Carboplatin AUC 5 or 6 plus Paclitaxel 175 mg/m2 q 21 days for 3 cycles
Drug: Carboplatin
Given IV
Other Name: Paraplatin

Drug: Paclitaxel
Given IV
Other Name: Taxol

Radiation: Radiation Therapy
Undergo Radiation Therapy
Other Names:
  • RT
  • Irradiation




Primary Outcome Measures :
  1. Recurrence-free survival (RFS) [ Time Frame: From study entry until disease recurrence, death, or date of last contact, assessed up to 8 years ]
    RFS will be assessed by radiology tests, patient's clinical symptoms or physical exam.


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: from study entry to death or date of last contact, assessed up to 8 years ]
    OS assessed by the contact with patient in person or by telephone


Other Outcome Measures:
  1. Incidence of acute and adverse effects as graded by the NCI Common Toxicity Criteria for Adverse Events version (CTCAE) version 4.0 [ Time Frame: From study entry through completion of study treatment, assessed for 1 year. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 ≥ 100,000/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.

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): NCT02501954


Contacts
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Contact: Joyce N Barlin, MD 518-458-1390 jbarlin@womenscancercareassociates.com
Contact: Kimberly A Fredericks, BS, CCRP 518-458-1390 kfredericks@womenscancercareassociates.com

Locations
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United States, Maryland
Greater Baltimore Medical Center Recruiting
Baltimore, Maryland, United States, 21204
Contact: Melissa Loomis    443-849-9123      
Principal Investigator: Kimberly Levinson, MD         
United States, New York
Women's Cancer Care Associates, LLC Recruiting
Albany, New York, United States, 12208
Contact: Joyce N Barlin, MD    518-458-1390    jbarlin@womenscancercareassociates.com   
Contact: Kimberly A Fredericks, BS, CCRP    518-458-1390    kfredericks@womenscancercareassociates.com   
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Amanda Dunson    614-688-8849      
Principal Investigator: Ritu Salani, MD         
United States, Virginia
The Univ. of Virginia, The Rector and Visitors of the Univ. of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Heather Lothamer    434-924-9924      
Principal Investigator: Leigh Cantrell, MD         
United States, Wisconsin
Gunderson Lutheran Medical Foundation Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Mari Erickson    608-775-6639 ext 3492      
Principal Investigator: Lori Weinberg, MD         
Canada, Quebec
CHUM Hopital Notre-Dame Recruiting
Montréal, Quebec, Canada, H2L4M1
Contact: Nathalie Grenier    514-890-8000 ext 25165      
Principal Investigator: Beatrice Cormier, MD         
Sponsors and Collaborators
Women's Cancer Care Associates, LLC
Investigators
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Principal Investigator: Joyce N Barlin, MD Women's Cancer Care Associates, LLC

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Responsible Party: Joyce N. Barlin, MD, Principal Investigator, Women's Cancer Care Associates, LLC
ClinicalTrials.gov Identifier: NCT02501954     History of Changes
Other Study ID Numbers: 15-07
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Adenocarcinoma
Uterine Neoplasms
Cystadenocarcinoma, Serous
Adenocarcinoma, Clear Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Cystadenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action