Pelvic IMRT With Tomotherapy in Post-Hysterectomy Endometrial Cancer Patients

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00334321

Enrollment

Registered

2006-06-07

Start date

2006-04-30

Completion date

2015-09-30

Last updated

2015-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer

Keywords

IMRT, Tomotherapy, Post-Hysterectomy, Endometrial Cancer

Brief summary

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

Interventions

RADIATIONIMRT

RADIATIONIntracavitary vaginal brachytherapy

DRUGPaclitaxel

DRUGCarboplatin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
The study will evaluate the feasibility of using helical tomotherapy to deliver IMRT in post-hysterectomy endometrial cancer patients receiving adjuvant radiotherapy.	1 year from the start of radiation therapy.	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.

Secondary

Measure	Time frame
Evaluate incidence of early toxicities	30 days after last day of radiation therapy
Evaluate incidence of late toxicities	1 year from the start of radiation therapy
Evaluate local, regional, and distant recurrence rates	5 years from start of radiation therapy
Evaluate 5-year disease-free and 5-year overall survival rates	5 years from start of radiation therapy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026