Pelvic IMRT With Tomotherapy in Post-Hysterectomy Endometrial Cancer Patients
NCT ID: NCT00334321
Last Updated: 2015-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
65 participants
INTERVENTIONAL
2006-04-30
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IMRT with chemotherapy
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
IMRT
Intracavitary vaginal brachytherapy
Paclitaxel
Carboplatin
Interventions
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IMRT
Intracavitary vaginal brachytherapy
Paclitaxel
Carboplatin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Karnofsky Performance Status of greater than or equal to 60
3. FIGO Surgical Stage I, II, and III
4. Pathologic confirmation of endometrial cancer
5. Patient status post hysterectomy
6. Patients with local or regional metastases are eligible for this protocol, but not those with distant metastases
7. Patients must have adequate:
* Bone Marrow Function:
* ANC ≥ 1,500/mcl (\< CTCAE v 3.0 Grade 1).
* Platelets ≥ 100,000/mcl (\< CTCAE v3.0 Grade 1).
* Renal Function:
* Serum creatinine ≤ institutional upper limit normal (ULN) (CTCAE v 3.0 Grade 0). Note: if serum creatinine \> ULN, a 24-hour creatinine clearance must be collected and must be \> 50 mL/min.
* Hepatic Function:
* Bilirubin ≤ 1.5 x ULN (\< CTCAE v 3.0 Grade 1).
* SGOT≤ 2.5 x ULN (\< CTCAE v 3.0 Grade 1).
* Alkaline phosphatase ≤ 2.5 x ULN (\< CTCAE v 3.0 Grade 1).
* Neurologic Function:
* Neuropathy (sensory and motor) \< CTCAE v 3.0 Grade 1.
Exclusion Criteria
2. Karnofsky Performance Status less than 60
3. Radiographic or pathologic evidence of metastatic disease (other than pelvic or para-aortic lymph nodes)
4. Prior pelvic radiation therapy
18 Years
FEMALE
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Perry W Grigsby, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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06-0297 / 201106410
Identifier Type: -
Identifier Source: org_study_id
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