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
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.
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.
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 →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.
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.
Exclusion Criteria:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Given IV
Also known as: Anzatax, Asotax, Taxol (TAX)
Given IV
Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Undergo external beam radiation therapy
Also known as: EBRT
Undergo HDR brachytherapy
Also known as: low-Linear energy transfer (LET) implant therapy, radiation brachytherapy, therapy, low-LET implant
Undergo IMRT
Also known as: IMRT
Correlative studies
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
14 participants were enrolled into the study between 7/08/2011-3/8/2016. Three participants screen failed prior to consenting.
| Milestone | Treatment (Paclitaxel, Carboplatin, Radiotherapy) |
|---|---|
| Started | 11 |
| Completed | 11 |
| Not completed | 0 |
One-year recurrence-free survival probability will be estimated, with 95% confidence limits based on exact methods for the binomial distribution.
No measurements were reported for this outcome.
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.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Paclitaxel, Carboplatin, Radiotherapy) | 0/11 (0%) | 0/11 (0%) | 2/11 (18.2%) |
| Event | Treatment (Paclitaxel, Carboplatin, Radiotherapy) |
|---|---|
| HypokalemiaMetabolism and nutrition disorders | 1/11 |
| HypomagnesemiaMetabolism and nutrition disorders | 1/11 |
| Urinary Tract InfectionInfections and infestations | 1/11 |
| Acute Kidney InjuryRenal and urinary disorders | 1/11 |
| AnemiaBlood and lymphatic system disorders | 1/11 |
| Febrile NeutropeniaBlood and lymphatic system disorders | 1/11 |
| AlopeciaSkin and subcutaneous tissue disorders | 1/11 |
| Peripheral Sensory NeuropathyNervous system disorders | 1/11 |
| Papulopustular RashInfections and infestations | 1/11 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/11 |
| Age, Categorical(Participants) | Treatment (Paclitaxel, Carboplatin, Radiotherapy) |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 11 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Treatment (Paclitaxel, Carboplatin, Radiotherapy) |
|---|---|
| Female | 11 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Treatment (Paclitaxel, Carboplatin, Radiotherapy) |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 9 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Treatment (Paclitaxel, Carboplatin, Radiotherapy) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 6 |
| White | 3 |
| More than one race | 1 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Treatment (Paclitaxel, Carboplatin, Radiotherapy) |
|---|---|
| United States | 11 |
PDFs hosted by the registry, ClinicalTrials.gov.
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
Albert Einstein College of Medicine →