Whole-Abdominal Radiation Therapy and Cisplatin in Treating Patients With Stage III or Stage IV Endometrial Cancer That Has Been Removed by Surgery
Condition: Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the
      growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Radiation therapy uses high-energy x-rays to kill tumor cells. Radiation therapy may also
      make tumor cells more sensitive to cisplatin. Giving radiation therapy together with
      cisplatin after surgery may kill any tumor cells that remain after surgery.

      PURPOSE: This phase I trial is studying the side effects and best dose of whole-abdominal
      radiation therapy when given together with cisplatin in treating patients with stage III or
      stage IV endometrial cancer that has been removed by surgery.
    

Detailed description: 
      OBJECTIVES:

        -  Determine a recommended phase II dose of adjuvant whole-abdominal radiotherapy when
           administered with cisplatin in patients with optimally debulked stage III or IV
           carcinoma of the endometrium.

      OUTLINE: This is a dose-escalation study of whole-abdominal radiotherapy (WAR).

      Patients receive 3 courses of standard chemotherapy comprising carboplatin IV and paclitaxel
      IV. Beginning within 6 weeks after completion of standard chemotherapy, patients receive
      cisplatin IV over 30-60 minutes and undergo a single fraction of WAR on day 1. Treatment with
      cisplatin and WAR repeats weekly for up to 6 courses in the absence of disease progression or
      unacceptable toxicity.

      Patients may undergo standard vaginal brachytherapy beginning no earlier than the last course
      of standard chemotherapy or no later than 1 week before the start of cisplatin and WAR.

      Cohorts of 3-6 patients receive escalating doses of WAR until the recommended phase II dose
      (RPTD) is determined. The RPTD is defined as the dose preceding that at which 2 of 3 or 2 of
      6 patients experience dose-limiting toxicity. At least 6 patients are treated at the RPTD.

      After completion of study treatment, patients are followed periodically.

      PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
    

Intervention name(s): Vaginal Brachytherapy; Cisplatin; Whole Abdominal Radiation [WAR] Therapy
Intervention type(s): Radiation; Drug; Radiation
Intervention description(s): High-Dose Rate [HDR] or Low-Dose Rate [LDR], no earlier than during last cycle of Carboplatin/Taxol chemotherapy; or no later than 1 week before cisplation and WAR therapy; Weekly at 40 mg/m2 (maximum of 70 mg) for 6 weeks, start no later than 6 weeks from last cycle of standard of care carboplatin and taxol chemotherapy; Whole Abdominal Radiation Therapy, Dose Escalated [2-Levels]; 6 -8 hours after administration of Cisplatin chemotherapy
Other intervention name(s): WAR
Intervention MeSH terms: Cisplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: endometrial adenocarcinoma; endometrial clear cell carcinoma; endometrial papillary carcinoma; stage III endometrial carcinoma; stage IV endometrial carcinoma