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NCT01367301 · REGISTRY CONDITION SEARCH

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

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
2023-08-21

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.

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 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 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) * 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
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Drug: paclitaxel
    2. Drug: carboplatin
    3. Radiation: external beam radiation therapy
    4. Radiation: brachytherapy
    5. Radiation: intensity-modulated radiation therapy
    6. Other: laboratory biomarker analysis
    label
    Treatment (paclitaxel, carboplatin, radiotherapy)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (paclitaxel, carboplatin, radiotherapy)
    description
    Given IV
    name
    paclitaxel
    other Names
    1. Anzatax
    2. Asotax
    3. Taxol (TAX)
    type
    DRUG
  2. arm Group Labels
    1. Treatment (paclitaxel, carboplatin, radiotherapy)
    description
    Given IV
    name
    carboplatin
    other Names
    1. Carboplat
    2. CBDCA
    3. JM-8
    4. Paraplat
    5. Paraplatin
    type
    DRUG
  3. arm Group Labels
    1. Treatment (paclitaxel, carboplatin, radiotherapy)
    description
    Undergo external beam radiation therapy
    name
    external beam radiation therapy
    other Names
    1. EBRT
    type
    RADIATION
  4. arm Group Labels
    1. Treatment (paclitaxel, carboplatin, radiotherapy)
    description
    Undergo HDR brachytherapy
    name
    brachytherapy
    other Names
    1. low-Linear energy transfer (LET) implant therapy
    2. radiation brachytherapy
    3. therapy, low-LET implant
    type
    RADIATION
  5. arm Group Labels
    1. Treatment (paclitaxel, carboplatin, radiotherapy)
    description
    Undergo IMRT
    name
    intensity-modulated radiation therapy
    other Names
    1. IMRT
    type
    RADIATION
  6. arm Group Labels
    1. Treatment (paclitaxel, carboplatin, radiotherapy)
    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
14
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    One-year recurrence-free survival probability will be estimated, with 95% confidence limits based on exact methods for the binomial distribution.
    measure
    Recurrence-free Survival
    time Frame
    Date of entry to date of reappearance of disease, assessed at 1 year
Full study description
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.
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.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-7b6f4a813894349d589f
      requested nct id
      NCT01367301
      primary nct id
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      source kind
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      source record id
      Source null
      source file sha256
      21b84c01b125d04528c86b8a2e80343ce07b200dcda51c3b1328a536daf43d89
      payload sha256
      cf04fa0c991b03d2409d987531676b8eed59641f61c77ebc12dc0edfc59d627c
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-7b6f4a813894349d589f
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
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      occurrences
      1. context exact
        NCT01367301
        end
        11
        exact text
        NCT01367301
        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/39/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      5f9341d8118a729c5347bf1eac986344cd93dd297593825ce6de32c84ba63b4d

    Preserved source evidence · Not medical advice