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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 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: July 13, 2015
Last verified: July 2015
  Purpose

This randomized phase II trial studies radiation therapy and cisplatin to see how well they work compared with radiation therapy alone in treating patients with endometrial cancer that has come back. 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, by stopping them from dividing, or by stopping them from spreading. 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 Adenocarcinoma
Endometrial Adenosquamous Carcinoma
Endometrial Clear Cell Adenocarcinoma
Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation
Endometrial Serous Adenocarcinoma
Recurrent Uterine Corpus Carcinoma
Radiation: 3-Dimensional Conformal Radiation Therapy
Drug: Cisplatin
Radiation: Intensity-Modulated Radiation Therapy
Radiation: Internal Radiation Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: 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, assessed 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, assessed up to 5 years ] [ Designated as safety issue: No ]
  • Incidence of adverse effects graded by CTCAE version 3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Prognostic significance of tumor size, tumor location (vaginal only vs. all others) and histology [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Additionally, age, race, and tumor grade will be evaluated as prognostic factors. These analyses will help to define the appropriate population with sufficient risk for future studies involving therapy that is more aggressive. A proportional hazards model adjusted for performance status and treatment will be used to explore the relationship between these variables and progression-free survival or survival.


Estimated Enrollment: 164
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 daily on days 1-5 for 5 weeks. After completion of EBRT, patients undergo intracavitary low-dose rate or high-dose rate brachytherapy or low-dose rate interstitial brachytherapy.
Radiation: 3-Dimensional Conformal Radiation Therapy
Given to the pelvis
Other Names:
  • 3-dimensional conformal radiation therapy
  • 3-dimensional radiation therapy
  • 3D-CRT
  • Conformal Therapy
  • Radiation Conformal Therapy
Radiation: Intensity-Modulated Radiation Therapy
Undergo IMRT
Other Names:
  • IMRT
  • Intensity Modulated RT
  • intensity-modulated radiation therapy
  • Intensity-Modulated Radiotherapy
Radiation: Internal Radiation Therapy
Given intracavitarily or interstitially
Other Names:
  • Brachytherapy
  • Internal Radiation
  • Internal Radiation Brachytherapy
  • Internal Radiation Therapy
  • Radiation Brachytherapy
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, and 29. Patients then undergo brachytherapy as in Arm I.
Radiation: 3-Dimensional Conformal Radiation Therapy
Given to the pelvis
Other Names:
  • 3-dimensional conformal radiation therapy
  • 3-dimensional radiation therapy
  • 3D-CRT
  • Conformal Therapy
  • Radiation Conformal Therapy
Drug: Cisplatin
Given IV
Other Names:
  • Abiplatin
  • Blastolem
  • Briplatin
  • CDDP
  • Cis-diammine-dichloroplatinum
  • Cis-diamminedichloridoplatinum
  • Cis-diamminedichloro Platinum (II)
  • Cis-diamminedichloroplatinum
  • Cis-dichloroammine Platinum (II)
  • Cis-platinous Diamine Dichloride
  • Cis-platinum
  • Cis-platinum II
  • Cis-platinum II Diamine Dichloride
  • Cismaplat
  • CISPLATIN
  • Cisplatina
  • Cisplatinum
  • Cisplatyl
  • Citoplatino
  • Citosin
  • Cysplatyna
  • DDP
  • Lederplatin
  • Metaplatin
  • Neoplatin
  • Peyrone's Chloride
  • Peyrone's Salt
  • Placis
  • Plastistil
  • Platamine
  • Platiblastin
  • Platiblastin-S
  • Platinex
  • Platinol
  • Platinol- AQ
  • Platinol-AQ
  • Platinol-AQ VHA Plus
  • Platinoxan
  • Platinum
  • Platinum Diamminodichloride
  • Platiran
  • Platistin
  • Platosin
Radiation: Intensity-Modulated Radiation Therapy
Undergo IMRT
Other Names:
  • IMRT
  • Intensity Modulated RT
  • intensity-modulated radiation therapy
  • Intensity-Modulated Radiotherapy
Radiation: Internal Radiation Therapy
Given intracavitarily or interstitially
Other Names:
  • Brachytherapy
  • Internal Radiation
  • Internal Radiation Brachytherapy
  • Internal Radiation Therapy
  • Radiation Brachytherapy

Detailed Description:

PRIMARY OBJECTIVES:

I. To assess whether pelvic radiation therapy with concurrent cisplatin is more promising with respect to progression-free survival than pelvic radiation therapy alone in the treatment of recurrent uterine carcinoma limited to the pelvis and vagina.

SECONDARY OBJECTIVES:

I. To capture the sites of recurrence subsequent to treatment with pelvic radiation with or without concurrent weekly cisplatin in women with recurrent uterine carcinoma.

II. To estimate overall survival of patients with recurrent uterine carcinoma treated with pelvic radiation therapy with or without concurrent weekly cisplatin.

III. To estimate 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 of the histological subtype, grade, patient age, race, performance status, and the presence of lymph-vascular space involvement of the original tumor at the time of initial hysterectomy.

IV. To evaluate toxicity derived from the combined cisplatin and radiation compared with radiation alone in this patient population.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo external-beam radiotherapy (EBRT) to the pelvis daily on days 1-5 for 5 weeks. 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 intravenously (IV) over 1-2 hours on days 1, 8, 15, 22, and 29. 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 up 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:

  • All patients must have undergone complete hysterectomy and bilateral salpingo-oophorectomy at the time of original therapy for their uterine carcinoma
  • Patients must have a biopsy with histologically confirmed diagnosis of recurrent endometrial cancer confined to the pelvis and/or vagina and no evidence of extrapelvic disease
  • Patients must have endometrial carcinoma including endometrioid adenocarcinoma, adenocarcinoma with squamous differentiation, mucinous adenocarcinoma, squamous cell carcinoma, mixed carcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, and serous adenocarcinoma histologies
  • Patients must have no evidence of extrapelvic disease; complete workup staging should be performed prior to initiation of therapy to rule-out presence of metastatic disease; this should include: computed tomography (CT) scan of the thorax with IV contrast, as well as a CT of the pelvis and abdomen with IV and oral (PO) contrast performed using multi-detector CT and equal or less than 5 mm slice thickness; if the patient is unable to tolerate contrast, then magnetic resonance imaging (MRI) with IV gadolinium should be performed; a chest x-ray should be done first, and if abnormal, then a CT scan of the chest should be done
  • 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 with complete resection of gross recurrent disease are eligible
  • Patients may have received prior hormone therapy and/or systemic chemotherapy; such therapy must have been completed at least 6 months prior to study entry and the patient has clear evidence of disease subsequent to such therapy; patients must not have received neoadjuvant chemotherapy for the present recurrent disease
  • Patients must have Gynecologic Oncology Group (GOG) performance status 0, 1, or 2
  • Patients must have an estimated survival greater or equal to 3 months
  • Absolute neutrophil count (ANC) >= 1,500/mm^3 , equivalent to Common Toxicity Criteria (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 3.0) grade 1
  • Platelets >= 100,000/mm^3, equivalent to CTCAE v 3.0 grade 0-1
  • Creatinine =< institutional upper limit normal (ULN), CTCAE v 3.0 grade 0; NOTE: if creatinine > ULN, creatinine clearance must be > 50 mL/min
  • Bilirubin =< 1.5 x ULN (CTCAE v 3.0 grade 1)
  • Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 x ULN (CTCAE v 3.0 grade 0-1)
  • Alkaline phosphatase =< 2.5 x ULN (CTCAE v 3.0 grade 0-1)
  • Neuropathy (sensory and motor) =< CTCAE v 3.0 grade 1
  • Patients with ureteral obstruction must undergo stent or nephrostomy tube placement prior to study entry
  • Patients who have met the pre-entry requirements
  • Patients must have signed an approved informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization

Exclusion Criteria:

  • Patients with evidence of disease outside of the pelvis, including presence of positive periaortic or inguino-femoral nodes
  • Patients who have received previous vaginal, pelvic, or abdominal irradiation
  • Patients who received chemotherapy directed at the present recurrence
  • Patients with septicemia or severe infection
  • Patients who have circumstances that will not permit completion of this study or the required follow-up
  • Patients with renal abnormalities, such as pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of radiation fields
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years; patients are also excluded if their previous cancer treatment contraindicates this protocol therapy
  • Patients 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
  • Patients who have a significant history of cardiac disease, i.e., uncontrolled hypertension, unstable angina, congestive heart failure, or uncontrolled arrhythmias within 6 months of registration
  • Patients with history of active collagen vascular disease
  • Patients with GOG performance grade of 3 or 4
  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 365 Study Locations
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Principal Investigator: Jonathan Feddock NRG Oncology
  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, U10CA180868, U10CA027469
Study First Received: June 25, 2007
Last Updated: July 13, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Clear Cell
Carcinoma
Carcinoma, Adenosquamous
Carcinoma, Endometrioid
Cystadenocarcinoma, Serous
Uterine Neoplasms
Adnexal Diseases
Cystadenocarcinoma
Endocrine System Diseases
Endometrial Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Complex and Mixed
Neoplasms, Cystic, Mucinous, and Serous
Neoplasms, Glandular and Epithelial
Ovarian Diseases
Ovarian Neoplasms
Urogenital Neoplasms
Uterine Diseases
Cisplatin
Succinylcholine
Antineoplastic Agents
Neuromuscular Agents
Neuromuscular Blocking Agents
Neuromuscular Depolarizing Agents

ClinicalTrials.gov processed this record on September 03, 2015