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Endometrial AdenocarcinomaPhase 2NCT01041027

Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Endometrial Cancer

A Phase 2 study testing Paclitaxel, Carboplatin and Internal Radiation Therapy in people with Endometrial Adenocarcinoma and Stage IA Uterine Corpus Cancer, run by Albert Einstein College of Medicine at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase II trial studies how well radiation therapy, paclitaxel, and carboplatin work in treating patients with high-risk endometrial 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
What is being tested?
Paclitaxel, Carboplatin and Internal Radiation Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteUnited States
Study dates
16 Jan 2009to 1 Oct 2019
Phase
Phase 2
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 high-risk endometrioid adenocarcinoma with no visible residual disease, defined by the following criteria:
  • Surgical stage I disease with < 50 myometrial invasion and grade 3 tumor (IAG3) with lymphovascular space involvement;
  • Surgical stage I disease with >= 50% myometrial invasion and grade 2 or 3 tumor (IBG2, IBG3);
  • Any surgical stage II disease (II);
  • Any surgical stage III disease (IIIA, IIIB, IIIC); and
  • Any surgical stage IV disease with no residual macroscopic tumor
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  • Surgical staging to include total abdominal hysterectomy, bilateral salpingo-oophorectomy, peritoneal washings, and lymph node samplings as per standard Gynecologic Oncology Group (GOG) criteria
  • 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/mm^3
  • Absolute neutrophil count (ANC) < 1500/mm^3
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  • 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 dementia or altered mental status that would prohibit the giving and understanding of informed consent at the time of study entry
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Albert Einstein College of Medicine

    The Bronx, New York, 10461

Other trials in United States

About this study

Official title: A Pilot Phase II Trial of Radiation Therapy "Sandwiched" Between Paclitaxel and Carboplatin in Patients With High-Risk Endometrial Cancer After Standard Surgical Staging

This phase II trial studies how well radiation therapy, paclitaxel, and carboplatin work in treating patients with high-risk endometrial 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, by stopping them from dividing or by stopping them from spreading. Giving radiation therapy with chemotherapy may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate progression-free survival. II. To assess and document location of disease recurrence (distant vs local vs both) using this treatment regimen.

II. To evaluate the toxicity of radiation therapy "sandwiched" between cycles of paclitaxel/carboplatin chemotherapy in patients with high-risk endometrial cancer.

III. To evaluate the associations of cancer recurrence with tumor tissue expression levels of insulin-like growth factor-I (IGF-I), IGF-II, insulin-like growth factor binding protein 1 (IGFBP-1) and -3, insulin receptor, IGF-I receptor, estrogen receptor, and progesterone receptor.

OUTLINE:

CHEMOTHERAPY (weeks 1-9, 13-21): 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 3 courses during weeks 13-21.

RADIATION THERAPY (weeks 8-13 or 8-15): Patients with stage I disease undergo high dose rate (HDR) brachytherapy once weekly for a total of 5 fractions during weeks 8-13. All other patients undergo external beam radiation therapy (EBRT) once daily (QD) 5 days a week for a total of 25 fractions during weeks 8-12 and HDR brachytherapy once weekly for a total of 3 fractions during weeks 13-15.

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

Being tested
Paclitaxel, Carboplatin, Internal Radiation Therapy, External Beam Radiation Therapy, Laboratory Biomarker Analysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

    Also called Anzatax, TAX

    Given IV

  • CarboplatinDrug

    Given IV

  • Internal Radiation TherapyRadiation

    Also called Brachytherapy, Internal Radiation, Internal Radiation Brachytherapy, Radiation Brachytherapy

    Undergo HDR brachytherapy

  • External Beam Radiation TherapyRadiation

    Also called Definitive Radiation Therapy, EBRT, External Beam RT

    Undergo EBRT

  • Laboratory Biomarker AnalysisOther

    Correlative studies

Study groups in NCT01041027
Study groupRoleWhat they receive
Treatment (paclitaxel, carboplatin, radiation therapy)ExperimentalCHEMOTHERAPY (weeks 1-9, 13-21): 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 3 courses during weeks 13-21. RADIATION THERAPY (weeks 8-13 or 8-15): Patients with stage I disease undergo HDR brachytherapy once weekly for a total of 5 fractions during weeks 8-13. All other patients undergo EBRT QD 5 days a week for a total of 25 fractions during weeks 8-12 and HDR brachytherapy once weekly for a total of 3 fractions during weeks 13-15.
Receives: Drug: Paclitaxel; Drug: Carboplatin; Radiation: Internal Radiation Therapy; Radiation: External Beam Radiation Therapy; Other: Laboratory Biomarker Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS)

    PFS will be analyzed using standard survival analytic methods, including the Kaplan-Meier approach for estimating the survival distribution. Median time to progression and 95% confidence intervals will be estimated from the Kaplan-Meier curves.

    Measured: From randomization until documented tumor recurrence or death from any cause, assessed up to 5 years

Secondary outcomes (8)

  1. Expression Levels of IGF-1

    Associations of PFS with tumor tissue expression levels of IGF-1 will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.

    Measured: Up to 5 years

  2. Expression Levels of IGF-2

    Associations of PFS with tumor tissue expression levels of IGF-2 will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.

    Measured: Up to 5 years

  3. Expression Levels of IGFBP-1

    Associations of PFS with tumor tissue expression levels of IGFBP-1 will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.

    Measured: Up to 5 years

  4. Expression Levels of IGFBP-3

    Associations of PFS with tumor tissue expression levels of IGFBP-3 will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.

    Measured: Up to 5 years

  5. Expression Levels of Insulin Receptor

    Associations of PFS with tumor tissue expression levels of insulin receptor will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.

    Measured: Up to 5 years

  6. Expression Levels of IGF-1 Receptor

    Associations of PFS with tumor tissue expression levels of IGF-1 receptor will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.

    Measured: Up to 5 years

  7. Expression Levels of Estrogen Receptor

    Associations of PFS with tumor tissue expression levels of estrogen receptor will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.

    Measured: Up to 5 years

  8. Expression Levels of Progesterone Receptor

    Associations of PFS with tumor tissue expression levels of progesterone receptor will be evaluated. Provided the number of events is sufficient, Cox proportional hazards models will be fit to the data to explore these associations.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2009 (estimated)
  2. Study start16 Jan 2009
  3. Primary completion1 Oct 2019
  4. Study completion1 Oct 2019

Why it stopped: Due to slow accrual. Results from the PORTEC3 the study rendered the hypothesis no longer valid.

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01041027
Sponsor's protocol ID
08-03-060
Other IDs
NCI-2013-01224, 07-062, NCI-2012-00458, 08-03-060, P30CA013330
Status last verified
Oct 2023
First submitted
29 Dec 2009
Last updated
26 Oct 2023
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel, Carboplatin and Internal Radiation Therapy in people with Endometrial Adenocarcinoma and Stage IA Uterine Corpus Cancer, 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 9 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 26 Oct 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Oct 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?

Progression-free Survival (PFS) (time frame: From randomization until documented tumor recurrence or death from any cause, assessed up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01041027.

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 26 Oct 2023.

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