Pelvic IMRT With Tomotherapy in Post-Hysterectomy Endometrial Cancer Patients

The Washington University

Status and phase: Completed; Phase 1

Conditions: Endometrial Cancer

Treatments: Drug: Carboplatin; Radiation: Intracavitary vaginal brachytherapy; Drug: Paclitaxel; Radiation: IMRT

Study type: Interventional

Funder types: Other

Identifiers

NCT00334321

06-0297 / 201106410

Details and patient eligibility

About

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

Enrollment: 65 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

IMRT with chemotherapy

Experimental group

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

Treatment:

Drug: Carboplatin

Drug: Paclitaxel

Radiation: Intracavitary vaginal brachytherapy

Radiation: IMRT