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Radiation Therapy With or Without Cisplatin in Treating Patients With Recurrent Endometrial Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Gynecologic Oncology Group
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00492778
First received: June 25, 2007
Last updated: March 7, 2014
Last verified: March 2014

June 25, 2007
March 7, 2014
February 2008
January 2017   (final data collection date for primary outcome measure)
Duration of progression-free survival [ Time Frame: From study entry until disease progression, death, or date of last contact, up to 5 years ] [ Designated as safety issue: No ]
Duration of progression-free survival
Complete list of historical versions of study NCT00492778 on ClinicalTrials.gov Archive Site
  • Duration of overall survival [ Time Frame: From entry into the study to death or the date of last contact, up to 5 years ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse effects assessed by Common Terminology Criteria for Adverse Events version 3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
Duration of overall survival
Not Provided
Not Provided
 
Radiation Therapy With or Without Cisplatin in Treating Patients With Recurrent Endometrial Cancer
A Randomized Trial of Pelvic Irradiation With or Without Concurrent Weekly Cisplatin in Patients With Pelvic-Only Recurrence of Carcinoma of the Uterine Corpus

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. 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.

PRIMARY OBJECTIVES:

I. 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 OBJECTIVES:

I. Compare the sites of recurrence in patients treated with these regimens. II. Compare overall survival of patients treated with these regimens. III. 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.

IV. 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 boost is allowed for patients who are not candidates for brachytherapy. IMRT may also be used for the entire course of therapy for the treatment of the whole pelvis and/or the boost in patients 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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Endometrial Adenoacanthoma
  • Endometrial Adenocarcinoma
  • Endometrial Adenosquamous Cell Carcinoma
  • Endometrial Clear Cell Carcinoma
  • Endometrial Papillary Serous Carcinoma
  • Recurrent Endometrial Carcinoma
  • Radiation: brachytherapy
    Given intracavitarily or interstitially
    Other Names:
    • low-LET implant therapy
    • radiation brachytherapy
    • therapy, low-LET implant
  • Radiation: 3-dimensional conformal radiation therapy
    Given to the pelvis
    Other Names:
    • 3D conformal radiation therapy
    • 3D-CRT
  • Drug: cisplatin
    Given IV
    Other Names:
    • CACP
    • CDDP
    • CPDD
    • DDP
  • Experimental: Arm I (brachytherapy, radiation therapy)
    Patients undergo 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.
    Interventions:
    • Radiation: brachytherapy
    • Radiation: 3-dimensional conformal radiation therapy
  • Experimental: Arm II (brachytherapy, radiation therapy, cisplatin)
    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.
    Interventions:
    • Radiation: brachytherapy
    • Radiation: 3-dimensional conformal radiation therapy
    • Drug: cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
210
Not Provided
January 2017   (final data collection date for primary outcome measure)

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
  • Primary surgical debulking before protocol therapy is permissible; this would include removal of gross symptomatic disease in the pelvis and/or vagina; exenterative surgery is not permissible; patients enrolled subsequent to revision 11 with complete resection of gross recurrent disease are eligible (05/14/2012)

    • Patients enrolled prior to revision 11 who have undergone complete surgical resection of the recurrent tumor and have no evidence of residual disease evaluable clinically and by CT or MRI imaging, following resection are not 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
Female
Not Provided
No
United States,   Canada
 
NCT00492778
GOG-0238, NCI-2009-00603, CDR0000550975, GOG-0238, GOG-0238, GOG-0238, U10CA027469
Not Provided
Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Higinia Cardenes Perera Gynecologic Oncology Group
Gynecologic Oncology Group
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP