NCT01367301

Brief Summary

This pilot clinical trial studies radiation therapy, paclitaxel, and carboplatin in treating patients with uterine cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or stopping them from dividing. Giving radiation with chemotherapy may kill more tumor cells.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

July 8, 2011

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2018

Completed
5 years until next milestone

Results Posted

Study results publicly available

August 21, 2023

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

7.1 years

First QC Date

June 3, 2011

Results QC Date

July 26, 2023

Last Update Submit

August 15, 2023

Conditions

Stage IA Uterine SarcomaStage IB Uterine SarcomaStage IC Uterine SarcomaStage IIA Uterine SarcomaStage IIB Uterine SarcomaStage IIIA Uterine SarcomaStage IIIB Uterine SarcomaStage IIIC Uterine SarcomaStage IVA Uterine SarcomaStage IVB Uterine SarcomaUterine Carcinosarcoma

Outcome Measures

Primary Outcomes (1)

  • Recurrence-free Survival

    One-year recurrence-free survival probability will be estimated, with 95% confidence limits based on exact methods for the binomial distribution.

    Date of entry to date of reappearance of disease, assessed at 1 year

Study Arms (1)

Treatment (paclitaxel, carboplatin, radiotherapy)

EXPERIMENTAL

CHEMOTHERAPY (weeks 1-9, 14-22): Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses during weeks 1-9 and 14-22. RADIATION THERAPY (weeks 8-16): Patients undergo external beam pelvic radiation therapy once a day, 5 days a week for 5 weeks during weeks 8-13. Patients then undergo HDR brachytherapy or IMRT once weekly during weeks 14-16.

Drug: paclitaxelDrug: carboplatinRadiation: external beam radiation therapyRadiation: brachytherapyRadiation: intensity-modulated radiation therapyOther: laboratory biomarker analysis

Interventions

paclitaxelDRUG

Given IV

Also known as: Anzatax, Asotax, Taxol (TAX)
Treatment (paclitaxel, carboplatin, radiotherapy)
carboplatinDRUG

Given IV

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Treatment (paclitaxel, carboplatin, radiotherapy)
external beam radiation therapyRADIATION

Undergo external beam radiation therapy

Also known as: EBRT
Treatment (paclitaxel, carboplatin, radiotherapy)
brachytherapyRADIATION

Undergo HDR brachytherapy

Also known as: low-Linear energy transfer (LET) implant therapy, radiation brachytherapy, therapy, low-LET implant
Treatment (paclitaxel, carboplatin, radiotherapy)
intensity-modulated radiation therapyRADIATION

Undergo IMRT

Also known as: IMRT
Treatment (paclitaxel, carboplatin, radiotherapy)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (paclitaxel, carboplatin, radiotherapy)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically documented uterine carcinosarcoma with no visible residual disease
  • Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node samplings
  • Patients must be entered no more than 12 weeks post operatively
  • Eastern Cooperative Oncology Group (ECOG) performance status of \< 2
  • Written voluntary informed consent

You may not qualify if:

  • Serum glutamic oxaloacetic transaminase (SGOT) and /or serum glutamate pyruvate transaminase (SGPT) \> 2.5 times the institutional upper limit of normal
  • Total serum bilirubin \> 1.5 mg/dl
  • History of chronic or active hepatitis
  • Serum creatinine \> 2.0 mg/dl
  • Platelets \< 100,000/mm3
  • Absolute neutrophil count (ANC) \< 1500/mm3
  • Hemoglobin \< 8.0 g/dl (the patient may be transfused prior to study entry)
  • Patient has severe or uncontrolled concurrent medical disease (e.g. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.)
  • Patient with any prior chemotherapy or radiotherapy for pelvic malignancy
  • Patients with any history of cancer with the exception of non-melanoma skin cancer are excluded if there is any evidence of other malignancy being present within the past five years
  • Patients with dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

MeSH Terms

Interventions

PaclitaxelTaxesCarboplatinBrachytherapyLinear Energy TransferTherapeuticsRadiotherapy, Intensity-Modulated

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesEconomicsHealth Care Economics and OrganizationsCoordination ComplexesRadiotherapyEnergy TransferBiophysical PhenomenaPhysical PhenomenaBiochemical PhenomenaChemical PhenomenaRadiotherapy, ConformalRadiotherapy, Computer-Assisted

Results Point of Contact

Title
Dr. Jessica Atrio, Professor, Department of Obstetrics & Gynecology and Women's Health
Organization
Albert Einstein College of Medicine - Montefiore Medical center
jatrio@montefiore.org
917-721-6155

Study Officials

  • Merieme Klobocista

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

  • Dennis Yi-Shin Kuo

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2011

First Posted

June 7, 2011

Study Start

July 8, 2011

Primary Completion

August 15, 2018

Study Completion

August 15, 2018

Last Updated

August 21, 2023

Results First Posted

August 21, 2023

Record last verified: 2023-08

Locations

US(1)