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
  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. 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.


Condition Intervention Phase
Endometrial Adenoacanthoma
Endometrial Adenocarcinoma
Endometrial Adenosquamous Cell Carcinoma
Endometrial Clear Cell Carcinoma
Endometrial Papillary Serous Carcinoma
Recurrent Endometrial Carcinoma
Radiation: brachytherapy
Radiation: 3-dimensional conformal radiation therapy
Drug: cisplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
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:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 210
Study Start Date: February 2008
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 225 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Higinia Cardenes Perera Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00492778     History of Changes
Other Study ID Numbers: GOG-0238, NCI-2009-00603, CDR0000550975, GOG-0238, GOG-0238, GOG-0238, U10CA027469
Study First Received: June 25, 2007
Last Updated: March 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Carcinoma, Adenosquamous
Adenocarcinoma, Clear Cell
Adenomyoepithelioma
Cystadenocarcinoma, Serous
Endometrial Neoplasms
Uterine Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Complex and Mixed
Cystadenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 19, 2014