Radiation Therapy With or Without Cisplatin in Treating Patients With Recurrent Endometrial Cancer - Full Text View

Sponsor:	Gynecologic Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00492778

Purpose

RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. 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. It is not yet known whether giving radiation therapy together with cisplatin is more effective than radiation therapy alone in treating patients with endometrial cancer.

PURPOSE: This randomized phase II trial is studying radiation therapy and cisplatin to see how well they work compared with radiation therapy alone in treating patients with recurrent endometrial cancer.

Condition	Intervention	Phase
Endometrial Cancer	Drug: cisplatin Radiation: brachytherapy Radiation: external beam radiation therapy	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Trial of Pelvic Irradiation With or Without Concurrent Weekly Cisplatin in Patients With Pelvic-Only Recurrence of Carcinoma of the Uterine Corpus

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Cisplatin

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Duration of progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of overall survival [ Designated as safety issue: No ]

Estimated Enrollment:	210
Study Start Date:	February 2008
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 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*	Radiation: brachytherapy Given intracavitarily or interstitially Radiation: external beam radiation therapy Given to the pelvis
Experimental: 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.	Drug: cisplatin Given IV Radiation: brachytherapy Given intracavitarily or interstitially Radiation: external beam radiation therapy Given to the pelvis

Detailed Description:

OBJECTIVES:

Primary

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.

Secondary

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 toxicity.

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT THERAPY:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492778

Show 141 Study Locations

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Higinia R. Cardenes, MD, PhD	Indiana University Melvin and Bren Simon Cancer Center
Investigator:	Julian C. Schink, MD	Robert H. Lurie Cancer Center
Investigator:	Penny Anderson, MD	Fox Chase Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Philip J. DiSaia, Gynecologic Oncology Group
ClinicalTrials.gov Identifier:	NCT00492778 History of Changes
Other Study ID Numbers:	CDR0000550975, GOG-0238
Study First Received:	June 25, 2007
Last Updated:	May 18, 2012
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

recurrent endometrial carcinoma
endometrial adenoacanthoma
endometrial adenocarcinoma

endometrial adenosquamous cell carcinoma
endometrial clear cell carcinoma
endometrial papillary serous carcinoma

Additional relevant MeSH terms:

Endometrial Neoplasms
Sarcoma, Endometrial Stromal
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Neoplasms, Complex and Mixed

Neoplasms by Histologic Type
Sarcoma
Neoplasms, Connective and Soft Tissue
Endometrial Stromal Tumors
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2012