Stage IA Uterine SarcomaNCT01367301
Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With Uterine Cancer
A study testing paclitaxel, carboplatin and external beam radiation therapy in people with Stage IA Uterine Sarcoma and Stage IB Uterine Sarcoma, run by Albert Einstein College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stage IA Uterine Sarcoma, Stage IB Uterine Sarcoma, Stage IC Uterine Sarcoma
- What is being tested?
- paclitaxel, carboplatin and external beam radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2011to 15 Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: A Pilot Trial of Radiation Therapy "Sandwiched" Between Paclitaxel and Carboplatin in Patients With Uterine Carcinosarcoma
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:
- 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.
- Conditions
- Stage IA Uterine Sarcoma, Stage IB Uterine Sarcoma, Stage IC Uterine Sarcoma, Stage IIA Uterine Sarcoma, Stage IIB Uterine Sarcoma, Stage IIIA Uterine Sarcoma
- Being tested
- paclitaxel, carboplatin, external beam radiation therapy, brachytherapy, intensity-modulated radiation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxelDrug
Also called Anzatax, Asotax, Taxol (TAX)
Given IV
carboplatinDrug
Also called Carboplat, CBDCA, JM-8, Paraplat
Given IV
external beam radiation therapyRadiation
Also called EBRT
Undergo external beam radiation therapy
brachytherapyRadiation
Also called low-Linear energy transfer (LET) implant therapy, radiation brachytherapy, therapy, low-LET implant
Undergo HDR brachytherapy
intensity-modulated radiation therapyRadiation
Also called IMRT
Undergo IMRT
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: paclitaxel; Drug: carboplatin; Radiation: external beam radiation therapy; Radiation: brachytherapy; Radiation: intensity-modulated radiation therapy; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free Survival
One-year recurrence-free survival probability will be estimated, with 95% confidence limits based on exact methods for the binomial distribution.
Measured: Date of entry to date of reappearance of disease, assessed at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study start8 Jul 2011
- Primary completion15 Aug 2018
- Study completion15 Aug 2018
Why it stopped: Lack of accrual. PI left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stage IA Uterine SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Merieme Klobocista, Principal investigator, Albert Einstein College of MedicineDennis Yi-Shin Kuo, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01367301
- Sponsor's protocol ID
- 11-02-064
- Other IDs
- NCI-2013-01225, 10-089, 11-02-064, P30CA013330
- Status last verified
- Aug 2023
- First submitted
- 3 Jun 2011
- Last updated
- 21 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Radiation Therapy "Sandwiched" Between Paclitaxel and Carboplatin in Patients With Uterine Carcinosarcoma
- ClinicalTrials.gov ID
- NCT01367301
- Acronym / sponsor ID
- 11-02-064
- Conditions
- Stage IA Uterine Sarcoma, Stage IB Uterine Sarcoma, Stage IC Uterine Sarcoma, Stage IIA Uterine Sarcoma, Stage IIB Uterine Sarcoma, Stage IIIA Uterine Sarcoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of accrual. PI left the institution
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Jul 2011 (actual)
- Primary completion
- 15 Aug 2018 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 7 Jun 2011 (estimated)
- Results
- Posted 21 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (paclitaxel, carboplatin, radiotherapy) | Experimental | Drug: paclitaxel, Drug: carboplatin, Radiation: external beam radiation therapy, Radiation: brachytherapy, Radiation: intensity-modulated radiation therapy, Other: laboratory biomarker analysisCHEMOTHERAPY (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paclitaxelAlso: Anzatax, Asotax, Taxol (TAX)Given IV | Drug | Treatment (paclitaxel, carboplatin, radiotherapy) |
| carboplatinAlso: Carboplat, CBDCA, JM-8, ParaplatGiven IV | Drug | Treatment (paclitaxel, carboplatin, radiotherapy) |
| external beam radiation therapyAlso: EBRTUndergo external beam radiation therapy | Radiation | Treatment (paclitaxel, carboplatin, radiotherapy) |
| brachytherapyAlso: low-Linear energy transfer (LET) implant therapy, radiation brachytherapy, therapy, low-LET implantUndergo HDR brachytherapy | Radiation | Treatment (paclitaxel, carboplatin, radiotherapy) |
| intensity-modulated radiation therapyAlso: IMRTUndergo IMRT | Radiation | Treatment (paclitaxel, carboplatin, radiotherapy) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (paclitaxel, carboplatin, radiotherapy) |
Primary outcome
Recurrence-free Survival
Time frame: Date of entry to date of reappearance of disease, assessed at 1 year
One-year recurrence-free survival probability will be estimated, with 95% confidence limits based on exact methods for the binomial distribution.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merieme Klobocista principal investigator
Albert Einstein College of Medicine
Dennis Yi-Shin Kuo principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing paclitaxel, carboplatin and external beam radiation therapy in people with Stage IA Uterine Sarcoma and Stage IB Uterine Sarcoma, run by Albert Einstein College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free Survival (time frame: Date of entry to date of reappearance of disease, assessed at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.