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Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Endometrial Cancer Patients


Phase 1
18 Years
N/A
Open (Enrolling)
Female
Endometrial Cancer

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Trial Information

Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Endometrial Cancer Patients


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The study will evaluate the feasibility of using helical tomotherapy to deliver IMRT in post-hysterectomy endometrial cancer patients receiving adjuvant radiotherapy.

Outcome Description:

The study will be deemed infeasible if greater than 10% of patients experience one of the following: Patient cannot be given the treatment because her anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised for her. The patient experiences any grade 4 acute toxicity judged to be related to her external radiation treatment. Within 1 year of the start of radiation therapy, the patient develops any grade 4 late toxicity judged to be related to her external radiation treatment. Within 1 year of the start of radiation therapy, the patient develops any in-field pelvic recurrence. Within 1 year of the start of radiation therapy, the patient dies from causes judged to be related to her treatment.

Outcome Time Frame:

1 year from the start of radiation therapy.

Safety Issue:

Yes

Principal Investigator

Perry W Grigsby, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

06-0297 / 201106410

NCT ID:

NCT00334321

Start Date:

April 2006

Completion Date:

April 2015

Related Keywords:

  • Endometrial Cancer
  • IMRT
  • Tomotherapy
  • Post-Hysterectomy
  • Endometrial Cancer
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110