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NCT01958580 · REGISTRY CONDITION SEARCH

Gemcitabine Hydrochloride, Docetaxel, and Radiation Therapy in Treating Patients With Uterine Sarcoma That Has Been Removed By Surgery

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
TERMINATED
Registry last update
2023-08-16

This pilot clinical trial studies gemcitabine hydrochloride, docetaxel, and radiation therapy in treating patients with uterine sarcoma that has been removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and docetaxel, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill tumor cells. Giving combination chemotherapy with radiation therapy may kill any tumor cells that remain after surgery.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Recurrence-free Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Histologically documented uterine leiomyosarcoma with no visible residual disease * Surgical staging to include total hysterectomy, +/- removal of ovaries and fallopian tubes, +/- lymph node sampling * Patients must be entered no more than 12 weeks post operatively * Eastern Cooperative Oncology Group (ECOG) performance status of \< 2 * Written voluntary informed consent Exclusion Criteria: * 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) * Patients with severe or uncontrolled concurrent medical disease (eg. uncontrolled diabetes, unstable angina, myocardial infarction within 6 months, congestive heart failure, etc.) * Patients with any prior chemotherapy or radiotherapy for pelvic malignancy * Patients who have had prior therapy with gemcitabine or docetaxel * Patients with known hypersensitivity to gemcitabine or docetaxel * Patients with known hypersensitivity to pegfilgrastim and filgrastim * 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
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    CHEMOTHERAPY: Patients receive gemcitabine hydrochloride IV over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. RADIATION THERAPY: Beginning week 10, patients undergo 3 fractions of brachytherapy or IMRT over 3 weeks. Patients then undergo EBRT QD 5 days a week for 5 weeks.
    intervention Names
    1. Drug: Gemcitabine Hydrochloride
    2. Drug: Docetaxel
    3. Radiation: Internal Radiation Therapy
    4. Radiation: Intensity-Modulated Radiation Therapy
    5. Radiation: External Beam Radiation Therapy
    6. Other: Laboratory Biomarker Analysis
    label
    Treatment (gemcitabine, docetaxel, brachytherapy/IMRT, EBRT)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (gemcitabine, docetaxel, brachytherapy/IMRT, EBRT)
    description
    Given IV
    name
    Gemcitabine Hydrochloride
    other Names
    1. Difluorodeoxycytidine (dFdC)
    2. dFdCyd
    type
    DRUG
  2. arm Group Labels
    1. Treatment (gemcitabine, docetaxel, brachytherapy/IMRT, EBRT)
    description
    Given IV
    name
    Docetaxel
    other Names
    1. TXT
    type
    DRUG
  3. arm Group Labels
    1. Treatment (gemcitabine, docetaxel, brachytherapy/IMRT, EBRT)
    description
    Undergo brachytherapy
    name
    Internal Radiation Therapy
    other Names
    1. Brachytherapy
    2. Internal Radiation
    3. Internal Radiation Brachytherapy
    4. Radiation Brachytherapy
    type
    RADIATION
  4. arm Group Labels
    1. Treatment (gemcitabine, docetaxel, brachytherapy/IMRT, EBRT)
    description
    Undergo IMRT
    name
    Intensity-Modulated Radiation Therapy
    other Names
    1. IMRT
    2. Intensity Modulated RT
    3. Intensity-Modulated Radiotherapy
    type
    RADIATION
  5. arm Group Labels
    1. Treatment (gemcitabine, docetaxel, brachytherapy/IMRT, EBRT)
    description
    Undergo EBRT
    name
    External Beam Radiation Therapy
    other Names
    1. Definitive Radiation Therapy
    2. EBRT
    3. External Beam RT
    type
    RADIATION
  6. arm Group Labels
    1. Treatment (gemcitabine, docetaxel, brachytherapy/IMRT, EBRT)
    description
    Correlative studies
    name
    Laboratory Biomarker Analysis
    type
    OTHER
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
3
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Two-year recurrence-free survival probability will be estimated, with 95% confidence limits based on exact methods for the binomial distribution. In the event of censoring before two years, a Kaplan-Meier estimate of the survival probability will be used and a Kaplan-Meier survival curve will be estimated and presented as well. The study was terminated prior to analyses
    measure
    Recurrence-free Survival
    time Frame
    Date of entry to date of reappearance of disease, assessed at 2 years. The study was terminated prior to analyses
Full study description
brief Summary
This pilot clinical trial studies gemcitabine hydrochloride, docetaxel, and radiation therapy in treating patients with uterine sarcoma that has been removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and docetaxel, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill tumor cells. Giving combination chemotherapy with radiation therapy may kill any tumor cells that remain after surgery.
detailed Description
PRIMARY OBJECTIVES: I. To evaluate the toxicity and tolerability of adjuvant pelvic radiation in combination with gemcitabine (gemcitabine hydrochloride)/docetaxel chemotherapy in patients with stage 1 and 2 surgically-resected uterine leiomyosarcoma. SECONDARY OBJECTIVES: I. To assess the two year recurrence-free survival in patients with uterine leiomyosarcoma treated with chemotherapy and radiation therapy including defining the patterns of recurrence in patients with uterine leiomyosarcoma who were treated with this regimen. OUTLINE: CHEMOTHERAPY: Patients receive gemcitabine hydrochloride intravenously (IV) over 90 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. RADIATION THERAPY: Beginning week 10, patients undergo 3 fractions of brachytherapy or intensity modulated radiation therapy (IMRT) over 3 weeks. Patients then undergo external beam radiation therapy (EBRT) once daily (QD) 5 days a week for 5 weeks. 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.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
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      requested nct id
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      payload
      clinical indication matching status
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      end exclusive
      true
      id
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      nct id
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      occurrences
      1. context exact
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        end
        11
        exact text
        NCT01958580
        start
        0
      offset unit
      unicode_code_points
      query cond
      Uterine Sarcoma
      query disease state id
      ds-uterine-sarcoma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-uterine-sarcoma-000.json
      source file sha256
      21b84c01b125d04528c86b8a2e80343ce07b200dcda51c3b1328a536daf43d89
      source json pointer
      /studies/22/protocolSection/identificationModule/nctId
      source kind
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      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      5ad657271074e46de172ce3ef91997628746bda65a12e6d40fd8efd7026b1e70

    Preserved source evidence · Not medical advice