Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Endometrial Cancer Patients
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| City: |
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St. Louis |
| State: |
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Missouri |
| Zip Code: |
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63110 |
| Conditions: |
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Endometrial Cancer |
| Purpose: |
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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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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
1. Age greater than or equal to 18 years of age
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:
1. Age less than 18 years of age
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
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| NCT ID: |
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NCT00334321 |
| Primary Contact: |
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Principal Investigator
Perry W Grigsby, M.D.
Washington University School of Medicine
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| Backup Contact: |
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N/A |
| Location Contact: |
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St. Louis, Missouri 63110
United States
There is no listed contact information for this specific location.
Site Status: N/A |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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