Pelvic IMRT With Tomotherapy in Post-Hysterectomy Endometrial Cancer Patients

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

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

Conditions
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Endometrial Cancer

Intervention / Treatment
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* Radiation: IMRT
* Radiation: Intracavitary vaginal brachytherapy
* Drug: Paclitaxel
* Drug: Carboplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMRT with chemotherapy<br>IMRT (upper third of vagina & para-vaginal tissue and the common, external and internal iliac nodal regions) 160-180 cGy daily fractions for a total dose of 4500-5120 cGy. Once a day treatment four to five days a week for approximately 6 weeks. Intracavitary vaginal brachytherapy - some patients will be given this and it will be decided by the treating physician. Carboplatin - AUC 6, IV over 30-60 minutes following completion of paclitaxel, given once every 3 weeks (3 weeks=1 cycles) for a total of 6 cycles Paclitaxel - 175 mg/m2, 3 hour continuous IV infusion, administered prior to carboplatin, given once every 3 weeks (3 weeks=1 cycles) for a total of 6 cycles | Radiation: IMRT<br> <br> Radiation: Intracavitary vaginal brachytherapy<br> <br> Drug: Paclitaxel<br> <br> * Other names: Taxol;Drug: Carboplatin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IMRT, Tomotherapy, Post-Hysterectomy, Endometrial Cancer