Pelvic IMRT With Tomotherapy in Post-Hysterectomy Endometrial Cancer Patients

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

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