Brief Title
Pelvic IMRT With Tomotherapy in Post-Hysterectomy Endometrial Cancer Patients
Official Title
Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Endometrial Cancer Patients
Brief Summary
This study is evaluating the feasibility of using helical tomotherapy to deliver IMRT in
post-hysterectomy endometrial cancer patients receiving adjuvant radiotherapy.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
The study will evaluate the feasibility of using helical tomotherapy to deliver IMRT in post-hysterectomy endometrial cancer patients receiving adjuvant radiotherapy.
Secondary Outcome
Evaluate incidence of early toxicities
Condition
Endometrial Cancer
Intervention
IMRT
Study Arms / Comparison Groups
IMRT with chemotherapy
Description: 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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Radiation
Estimated Enrollment
65
Start Date
April 2006
Completion Date
September 2015
Primary Completion Date
April 2011
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Perry W Grigsby, M.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00334321
Organization ID
06-0297 / 201106410
Responsible Party
Sponsor
Study Sponsor
Washington University School of Medicine
Study Sponsor
Perry W Grigsby, M.D., Principal Investigator, Washington University School of Medicine
Verification Date
October 2015