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A Randomized Trial of Pelvic Irradiation With or Without Concurrent Weekly Cisplatin in Patients With Pelvic-Only Recurrence of Carcinoma of the Uterine Corpus

Phase 2
Open (Enrolling)
Endometrial Cancer

Thank you

Trial Information

A Randomized Trial of Pelvic Irradiation With or Without Concurrent Weekly Cisplatin in Patients With Pelvic-Only Recurrence of Carcinoma of the Uterine Corpus



- Determine whether pelvic radiotherapy and cisplatin are more promising with respect to
progression-free survival than pelvic radiotherapy alone in patients with recurrent
endometrial cancer limited to the pelvis and vagina.


- Compare the sites of recurrence in patients treated with these regimens.

- Compare overall survival of patients treated with these regimens.

- Compare the prognostic significance of the location (central pelvis versus vagina) and
size of the recurrence, in addition to the prognostic significance in the salvage
setting, in terms of histological subtype, grade, age, race, performance status, and
the presence of lymph-vascular space involvement of the original tumor at the time of
initial hysterectomy, in patients treated with these regimens.

- Compare the toxicity of these regimens in these patients.

OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients undergo external-beam radiotherapy (EBRT) to the pelvis on days 1-5,
8-12, 15-19, 22-26, 29-33, and 36-40. After completion of EBRT, patients undergo
intracavitary low-dose rate or high-dose rate brachytherapy* or low-dose rate
interstitial brachytherapy*.

- Arm II: Patients undergo EBRT as in arm I and receive cisplatin IV over 1-2 hours on
days 1, 8, 15, 22, 29, and 36. Patients then undergo brachytherapy* as in arm I.

NOTE: *IMRT will be allowed for the entire course of therapy, this is for the treatment of
the whole pelvis and/or the boost in those cases not undergoing brachytherapy.

In both arms, treatment continues in the absence of disease progression or unacceptable

After completion of study treatment, patients are followed monthly for 3 months, every 3
months for 2 years, and then every 6 months for 3 years.

Inclusion Criteria


- Histologically confirmed diagnosis of endometrial cancer, including the following
histological subtypes:

- Adenocarcinoma

- Adenocarcinoma with squamous differentiation

- Mucinous adenocarcinoma

- Squamous cell carcinoma

- Mixed carcinoma

- Undifferentiated carcinoma

- Clear cell adenocarcinoma

- Serous adenocarcinoma

- Must have undergone prior complete hysterectomy and bilateral salpingo-oophorectomy
at the time of original therapy

- Recurrent disease confined to the pelvis and/or vagina

- No evidence of extrapelvic disease, including positive periaortic or
inguino-femoral nodes by chest x-ray or CT scan

- Prior primary surgical debulking (including removal of gross symptomatic disease in
the pelvis and/or vagina) allowed provided there is residual disease that is
evaluable clinically and/or by CT scan or MRI

- Exenterative surgery is not permissible

- Patients who have undergone prior complete surgical resection of the recurrent
tumor and have no evidence of residual disease evaluable clinically and by CT
scan or MRI after resection are not eligible

- Patients enrolled subsequent to revision 11 with complete resection of
gross recurrent disease are eligible

- Patients with ureteral obstruction must undergo stent or nephrostomy tube placement
prior to study entry


- GOG performance status 0-2

- Life expectancy ≥ 3 months

- Absolute neutrophil count ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Creatinine normal OR creatinine clearance > 50 mL/min

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

- SGOT ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- No sensory or motor neuropathy > grade 1

- No septicemia or severe infection

- No circumstances that would preclude study participation

- No renal abnormalities (i.e., pelvic kidney, horseshoe kidney, or prior renal
transplantation) that would require modification of radiation fields

- No other invasive malignancies within the past 5 years except nonmelanoma skin cancer

- No significant history of cardiac disease, including uncontrolled hypertension,
unstable angina, congestive heart failure, or uncontrolled arrhythmias within the
past 6 months

- No history of active collagen vascular disease


- At least 6 months since prior hormone therapy and/or systemic chemotherapy

- No prior neoadjuvant chemotherapy for recurrent disease

- No prior exenterative surgery

- No prior vaginal, pelvic, or abdominal irradiation

- No prior chemotherapy directed at the present recurrent disease

- No prior cancer treatment that would preclude study treatment

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Duration of progression-free survival

Safety Issue:


Principal Investigator

Shu-Yuan Liao, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Joseph Hospital Health Center


United States: NCI, OHRP

Study ID:




Start Date:

February 2008

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • recurrent endometrial carcinoma
  • endometrial adenoacanthoma
  • endometrial adenocarcinoma
  • endometrial adenosquamous cell carcinoma
  • endometrial clear cell carcinoma
  • endometrial papillary serous carcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma



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