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This study is evaluating the feasibility of using helical tomotherapy to deliver IMRT in post-hysterectomy endometrial cancer patients receiving adjuvant radiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMRT with chemotherapy | Experimental | IMRT (upper third of vagina & para-vaginal tissue and the common, external and internal iliac nodal regions) 160-180 cGy daily fractions for a total dose of 4500-5120 cGy. Once a day treatment four to five days a week for approximately 6 weeks. Intracavitary vaginal brachytherapy - some patients will be given this and it will be decided by the treating physician. Carboplatin - AUC 6, IV over 30-60 minutes following completion of paclitaxel, given once every 3 weeks (3 weeks=1 cycles) for a total of 6 cycles Paclitaxel - 175 mg/m2, 3 hour continuous IV infusion, administered prior to carboplatin, given once every 3 weeks (3 weeks=1 cycles) for a total of 6 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMRT | Radiation |
| ||
| Intracavitary vaginal brachytherapy |
| Measure | Description | Time Frame |
|---|---|---|
| The study will evaluate the feasibility of using helical tomotherapy to deliver IMRT in post-hysterectomy endometrial cancer patients receiving adjuvant radiotherapy. | The study will be deemed infeasible if greater than 10% of patients experience one of the following:
| 1 year from the start of radiation therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate incidence of early toxicities | 30 days after last day of radiation therapy | |
| Evaluate incidence of late toxicities | 1 year from the start of radiation therapy | |
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Inclusion Criteria:
Age greater than or equal to 18 years of age
Karnofsky Performance Status of greater than or equal to 60
FIGO Surgical Stage I, II, and III
Pathologic confirmation of endometrial cancer
Patient status post hysterectomy
Patients with local or regional metastases are eligible for this protocol, but not those with distant metastases
Patients must have adequate:
Bone Marrow Function:
Renal Function:
Hepatic Function:
Neurologic Function:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Perry W Grigsby, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Radiation |
|
| Paclitaxel | Drug |
|
|
| Carboplatin | Drug |
|
| Evaluate local, regional, and distant recurrence rates |
| 5 years from start of radiation therapy |
| Evaluate 5-year disease-free and 5-year overall survival rates | 5 years from start of radiation therapy |
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |