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CompletedNCT02501954Updated Jul 23, 2024

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

A Phase 3 interventional study of Cisplatin and Carboplatin in Endometrial Clear Cell Adenocarcinoma, Endometrial Serous Adenocarcinoma and Stage IIIA Uterine Corpus Cancer, sponsored by Women's Cancer Care Associates, LLC. Completed at 7 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-23.

Sponsored by Women's Cancer Care Associates, LLC · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Mar 2015, registered Jul 2015).
Phase
Phase 3
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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

Read the 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.

02

Conditions studied

  • 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
03

In context

Lead sponsor

This is the only study on the registry with Women's Cancer Care Associates, LLC as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • 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 · Drug: Carboplatin · Drug: Paclitaxel · Radiation: Radiation Therapy

  • 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 · Drug: Paclitaxel · Radiation: Radiation Therapy

Interventions

  • DrugCisplatin

    Given IV

    Also known as: Platinol

  • DrugCarboplatin

    Given IV

    Also known as: Paraplatin

  • DrugPaclitaxel

    Given IV

    Also known as: Taxol

  • RadiationRadiation Therapy

    Undergo Radiation Therapy

    Also known as: RT, Irradiation

06

What researchers measure

Primary outcomes

  1. Recurrence-free survival (RFS)

    RFS will be assessed by radiology tests, patient's clinical symptoms or physical exam.

    Time frame: From study entry until disease recurrence, death, or date of last contact, assessed up to 8 years

Secondary outcomes

  1. Overall survival (OS)

    OS assessed by the contact with patient in person or by telephone

    Time frame: from study entry to death or date of last contact, assessed up to 8 years

Other outcomes

  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.

07

Study locations

7 sites
  • Greater Baltimore Medical Center
    Baltimore, Maryland 21204, United States
  • Munson Health Care
    Traverse City, Michigan 49684, United States
  • Atlantic Health
    Morristown, New Jersey 07960, United States
  • Women's Cancer Care Associates, LLC
    Albany, New York 12208, United States
  • The Ohio State University
    Columbus, Ohio 43210, United States
  • Gunderson Lutheran Medical Foundation
    La Crosse, Wisconsin 54601, United States
  • CHUM Hopital Notre-Dame
    Montreal, Quebec H2L4M1, Canada
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2015 to primary completion in Nov 2023, 104 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 9, 2015
First posted
Jul 17, 2015
StartActual
Mar 2015
Primary completionActual
Nov 2023
CompletionActual
Nov 2023
Last update
Jul 23, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02501954
Lead sponsor
Women's Cancer Care Associates, LLC
Responsible party
Joyce N. Barlin, MD (Principal Investigator, Women's Cancer Care Associates, LLC) — Principal investigator
First posted
Jul 17, 2015
Start date
Mar 2015
Primary completion
Nov 2023
Completion
Nov 2023
Last update
Jul 23, 2024

Study contacts

Joyce N Barlin, MD
principal investigator · Women's Cancer Care Associates, LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Cisplatin

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