Pelvic IMRT With Tomotherapy in Post-Hysterectomy Endometrial Cancer Patients

Completed · Phase 1

Conditions studied: Endometrial Cancer

In brief

This study is evaluating the feasibility of using helical tomotherapy to deliver IMRT in post-hysterectomy endometrial cancer patients receiving adjuvant radiotherapy.

Key facts

Study ID

NCT00334321

Run by

Washington University School of Medicine

People needed

65

Starts

2006-04-01

Expected to finish

2015-09-01

Last updated by the study team

2015-10-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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