Status:
COMPLETED
Pelvic IMRT With Tomotherapy in Post-Hysterectomy Endometrial Cancer Patients
Lead Sponsor:
Washington University School of Medicine
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
This study is evaluating the feasibility of using helical tomotherapy to deliver IMRT in post-hysterectomy endometrial cancer patients receiving adjuvant radiotherapy.
Eligibility Criteria
Inclusion
- 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:
- 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
- Age less than 18 years of age
- Karnofsky Performance Status less than 60
- Radiographic or pathologic evidence of metastatic disease (other than pelvic or para-aortic lymph nodes)
- Prior pelvic radiation therapy
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00334321
Start Date
April 1 2006
End Date
September 1 2015
Last Update
October 5 2015
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110