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A Phase I Study Using Abdominal Radiotherapy as a Cisplatin Chemosensitizer for Optimally Debulked Stage III/IV Carcinoma of the Endometrium

Phase 1
18 Years
80 Years
Not Enrolling
Endometrial Cancer

Thank you

Trial Information

A Phase I Study Using Abdominal Radiotherapy as a Cisplatin Chemosensitizer for Optimally Debulked Stage III/IV Carcinoma of the Endometrium


- 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

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.

Inclusion Criteria


- Diagnosis of endometrial cancer, including any of the following cellular types:

- Papillary serous carcinoma

- Clear cell carcinoma

- Adenocarcinoma

- Stage III or IV disease

- No evidence of extra-abdominal extension of disease (e.g., groin nodes, lung, or
supraclavicular nodes)

- Has undergone total-abdominal hysterectomy, surgical removal of any present fallopian
tube and ovary, and resection of any palpable lymph nodes in the pelvis and
para-aortic region (or surgical sampling of these nodal regions if no palpable nodes
were present) within the past 6 weeks

- Peritoneal washings must have been collected for cytological evaluation

- Must have ≤ 1 cm residual disease after surgery


- Karnofsky performance status 60-100%

- Life expectancy ≥ 6 months

- WBC ≥ 3,000/mm^3

- Granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Creatinine < 2.0 mg/dL

- Bilirubin < 1.5 times upper limit of normal (ULN)

- Lactate dehydrogenase < 3 times ULN

- Gamma glutamyl transferase < 3 times ULN

- SGPT and SGOT < 3 times ULN

- Alkaline phosphatase < 3 times ULN

- No other malignant tumor within the past 5 years


- See Disease Characteristics

- No prior radiotherapy to the whole abdomen and/or pelvis/vagina

- No systemic chemotherapy within the past 5 years

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity as assessed by GOG Common Toxicity Criteria

Outcome Time Frame:

Study duration

Safety Issue:


Principal Investigator

Aaron H. Wolfson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

May 2002

Completion Date:

March 2011

Related Keywords:

  • Endometrial Cancer
  • endometrial adenocarcinoma
  • endometrial clear cell carcinoma
  • endometrial papillary carcinoma
  • stage III endometrial carcinoma
  • stage IV endometrial carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma



University of Miami Sylvester Comprehensive Cancer Center - MiamiMiami, Florida  33136