Pelvic IMRT With Tomotherapy in Post-Hysterectomy Endometrial Cancer Patients

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00334321
• Other study ID #: 06-0297 / 201106410
• Status: Completed
• Phase: Phase 1
• First received: June 6, 2006
• Last updated: October 1, 2015
• Start date: April 2006
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: September 2015
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Radiation:
• IMRT

• Intracavitary vaginal brachytherapy

Drug:
• Paclitaxel

• Carboplatin

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The study will evaluate the feasibility of using helical tomotherapy to deliver IMRT in post-hysterectomy endometrial cancer patients receiving adjuvant radiotherapy.	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.	1 year from the start of radiation therapy.	Yes
Secondary	Evaluate incidence of early toxicities		30 days after last day of radiation therapy	Yes
Secondary	Evaluate incidence of late toxicities		1 year from the start of radiation therapy	Yes
Secondary	Evaluate local, regional, and distant recurrence rates		5 years from start of radiation therapy	No
Secondary	Evaluate 5-year disease-free and 5-year overall survival rates		5 years from start of radiation therapy	No

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine