ClinicalTrials.gg
TerminatedNCT01367301Updated Aug 21, 2023Results posted

Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With Uterine Cancer

An interventional study of paclitaxel and carboplatin in Stage IA Uterine Sarcoma, Stage IB Uterine Sarcoma and Stage IC Uterine Sarcoma, sponsored by Albert Einstein College of Medicine. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-21.

Sponsored by Albert Einstein College of Medicine · Not applicable, Interventional, and Treatment

Why this study was terminated
Lack of accrual. PI left the institution
Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the detailed description

PRIMARY OBJECTIVES:

I. To assess the one year recurrence-free survival in patients with uterine carcinosarcoma treated with "sandwich" therapy-including defining the patterns of recurrence in patients with carcinosarcoma who were treated with this regimen.

II. To evaluate the toxicity and tolerability of pelvic radiation "sandwiched" between cycles of paclitaxel/carboplatin chemotherapy in patients with uterine carcinosarcoma.

III. To correlate surrogate endpoint biomarkers with progression-free survival and prognosis.

OUTLINE:

CHEMOTHERAPY (weeks 1-9, 14-22): Patients receive paclitaxel intravenously (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 high dose radiation (HDR) brachytherapy or intensity-modulated radiation therapy (IMRT) once weekly during weeks 14-16.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

02

Conditions studied

  • Stage IA Uterine Sarcoma
  • Stage IB Uterine Sarcoma
  • Stage IC Uterine Sarcoma
  • Stage IIA Uterine Sarcoma
  • Stage IIB Uterine Sarcoma
  • Stage IIIA Uterine Sarcoma
  • Stage IIIB Uterine Sarcoma
  • Stage IIIC Uterine Sarcoma
  • Stage IVA Uterine Sarcoma
  • Stage IVB Uterine Sarcoma
  • Uterine Carcinosarcoma

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03

In context

Carcinosarcoma

60 studies on the registry are indexed under Carcinosarcoma; 12 are open to participants now.

This study's enrollment of 14 is below the median of 48 across 52 interventional studies indexed under Carcinosarcoma.

Browse Carcinosarcoma studies →

Lead sponsor

Albert Einstein College of Medicine is the lead sponsor of 201 studies on the registry; 21 are open to participants now.

Of its 46 completed or terminated interventional studies of FDA-regulated products, 37 (80%) have results posted.

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

  • 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
  • (ECOG) performance status of \< 2
  • Written voluntary

Exclusion criteria

Exclusion Criteria:

  • Serum glutamic oxaloacetic transaminase () and /or serum glutamate pyruvate transaminase (SGPT) > 2.5 times the institutional
  • Total serum > 1.5 mg/dl
  • History of chronic or active hepatitis
  • Serum creatinine > 2.0 mg/dl
  • \< 100,000/mm3
  • (ANC) \< 1500/mm3
  • \< 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
  • 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 at the time of study entry
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    Treatment (paclitaxel, carboplatin, radiotherapy)

    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: paclitaxel · Drug: carboplatin · Radiation: external beam radiation therapy · Radiation: brachytherapy · Radiation: intensity-modulated radiation therapy · Other: laboratory biomarker analysis

Interventions

  • Given IV

    Also known as: Anzatax, Asotax, Taxol (TAX)

  • Given IV

    Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin

  • Radiationexternal beam radiation therapy

    Undergo external beam radiation therapy

    Also known as: EBRT

  • Radiationbrachytherapy

    Undergo HDR brachytherapy

    Also known as: low-Linear energy transfer (LET) implant therapy, radiation brachytherapy, therapy, low-LET implant

  • Radiationintensity-modulated radiation therapy

    Undergo IMRT

    Also known as: IMRT

  • Otherlaboratory biomarker analysis

    Correlative studies

06

What researchers measure

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.

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

07

Results

Posted Aug 21, 2023

Participant flow

14 participants were enrolled into the study between 7/08/2011-3/8/2016. Three participants screen failed prior to consenting.

Participant flow — Overall Study
MilestoneTreatment (Paclitaxel, Carboplatin, Radiotherapy)
Started11
Completed11
Not completed0

Outcome measures

PrimaryRecurrence-free Survival

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

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

No measurements were reported for this outcome.

Adverse events

Collected over Every 3 months for the first 2 years and every 6 months for the next 3 years. Up to 5 years total as described in Section 7.4 of the Study Protocol.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Treatment (Paclitaxel, Carboplatin, Radiotherapy)0/11 (0%)0/11 (0%)2/11 (18.2%)
Most frequent other events
Showing 10 of 11
Most frequent other events
EventTreatment (Paclitaxel, Carboplatin, Radiotherapy)
HypokalemiaMetabolism and nutrition disorders1/11
HypomagnesemiaMetabolism and nutrition disorders1/11
Urinary Tract InfectionInfections and infestations1/11
Acute Kidney InjuryRenal and urinary disorders1/11
AnemiaBlood and lymphatic system disorders1/11
Febrile NeutropeniaBlood and lymphatic system disorders1/11
AlopeciaSkin and subcutaneous tissue disorders1/11
Peripheral Sensory NeuropathyNervous system disorders1/11
Papulopustular RashInfections and infestations1/11
ThrombocytopeniaBlood and lymphatic system disorders1/11

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Treatment (Paclitaxel, Carboplatin, Radiotherapy)
<=18 years0
Between 18 and 65 years11
>=65 years0
Sex: Female, Male
Sex: Female, Male(Participants)Treatment (Paclitaxel, Carboplatin, Radiotherapy)
Female11
Male0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Treatment (Paclitaxel, Carboplatin, Radiotherapy)
Hispanic or Latino2
Not Hispanic or Latino9
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Treatment (Paclitaxel, Carboplatin, Radiotherapy)
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American6
White3
More than one race1
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Treatment (Paclitaxel, Carboplatin, Radiotherapy)
United States11
08

Study locations

1 site
  • Albert Einstein College of Medicine
    Bronx, New York 10461, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01367301
Responsible party
Sponsor
First posted
Jun 7, 2011
Start date
Jul 8, 2011
Primary completion
Aug 15, 2018
Completion
Aug 15, 2018
Results posted
Aug 21, 2023
Last update
Aug 21, 2023

Study contacts

Merieme Klobocista
principal investigator · Albert Einstein College of Medicine
Dennis Yi-Shin Kuo
principal investigator · Montefiore Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Paclitaxel · Carboplatin

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