Pelvic IMRT With Tomotherapy in Post-Hysterectomy Endometrial Cancer Patients

Phase 1

Completed

• Conditions: Endometrial Cancer
• Interventions: Radiation: IMRT; Radiation: Intracavitary vaginal brachytherapy; Drug: Paclitaxel; Drug: Carboplatin

• Registration Number: NCT00334321
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-06-06
• Study First Submitted QC: 2006-06-06
• Study First Posted: 2006-06-07
• Primary Completion: 2011-04
• Study Completion: 2015-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-01
• Last Update Posted: 2015-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 65

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IMRT with chemotherapy	Intracavitary vaginal brachytherapy	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
IMRT with chemotherapy	IMRT	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
IMRT with chemotherapy	Paclitaxel	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
IMRT with chemotherapy	Carboplatin	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

Primary Outcome Measures

Name	Time	Method
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.; ...

Secondary Outcome Measures

Name	Time	Method
Evaluate local, regional, and distant recurrence rates	5 years from start of radiation therapy
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 5-year disease-free and 5-year overall survival rates	5 years from start of radiation therapy

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 St. Louis, Missouri, United States