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

Not Applicable

Terminated

• Conditions: Uterine Carcinosarcoma; Stage IB Uterine Sarcoma; Stage IC Uterine Sarcoma; Stage IIB Uterine Sarcoma; Stage IVA Uterine Sarcoma; Stage IVB Uterine Sarcoma; Stage IA Uterine Sarcoma; Stage IIA Uterine Sarcoma; Stage IIIC Uterine Sarcoma; Stage IIIA Uterine Sarcoma
• Interventions: Drug: paclitaxel; Drug: carboplatin; Radiation: external beam radiation therapy; Radiation: brachytherapy; Radiation: intensity-modulated radiation therapy; Other: laboratory biomarker analysis

• Registration Number: NCT01367301
• Lead Sponsor: Albert Einstein College of Medicine

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.

Study Timeline

• Study First Submitted: 2011-06-03
• Study First Submitted QC: 2011-06-06
• Study First Posted: 2011-06-07
• Study Start: 2011-07-08
• Primary Completion: 2018-08-15
• Study Completion: 2018-08-15
• Results First Submitted: 2023-07-26
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-15
• Last Update Submitted: 2023-08-15
• Results First Posted: 2023-08-21
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (paclitaxel, carboplatin, radiotherapy)	brachytherapy	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.
Treatment (paclitaxel, carboplatin, radiotherapy)	external beam radiation therapy	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.
Treatment (paclitaxel, carboplatin, radiotherapy)	intensity-modulated radiation therapy	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.
Treatment (paclitaxel, carboplatin, radiotherapy)	laboratory biomarker analysis	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.
Treatment (paclitaxel, carboplatin, radiotherapy)	paclitaxel	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.
Treatment (paclitaxel, carboplatin, radiotherapy)	carboplatin	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.

Primary Outcome Measures

Name	Time	Method
Recurrence-free Survival	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.

Trial Locations

Locations (1)

Albert Einstein College of Medicine; 🇺🇸 Bronx, New York, United States