Comparison of Two Combination Chemotherapy Regimens Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer

This study has been completed.
Sponsor:
Collaborators:
Eastern Cooperative Oncology Group
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00006011
First received: July 5, 2000
Last updated: April 30, 2015
Last verified: April 2015
  Purpose

Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens plus radiation therapy in treating patients who have stage III or stage IV endometrial cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. It is not yet known which combination chemotherapy regimen plus radiation therapy is more effective for endometrial cancer.


Condition Intervention Phase
Endometrial Adenocarcinoma
Endometrial Adenosquamous Carcinoma
Endometrial Clear Cell Adenocarcinoma
Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation
Endometrial Serous Adenocarcinoma
Stage III Uterine Corpus Cancer
Drug: Doxorubicin Hydrochloride
Drug: Cisplatin
Biological: Filgrastim
Biological: Pegfilgrastim
Drug: Paclitaxel
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Study of Tumor Volume Directed Pelvic Plus or Minus Para-Aortic Irradiation Followed by Cisplatin and Doxorubicin or Cisplatin, Doxorubicin and Paclitaxel for Advanced Endometrial Carcinoma

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Recurrence-Free Survival of Eligible Patients Who Received a Random Treatment Allocation. [ Time Frame: study entry up to 5 years post treatment ] [ Designated as safety issue: No ]

    Recurrence is defined as discovery of disease not previously present by clinical, radiographic, and/or laboratory means or as a 50% or greater increase in the product of two perpendicular diameters from any documented lesion.

    Recurrence-free survival is defined as time in months the patient is alive, recurrence-free starting from the date of randomization.

    Intention to treat among eligible participants who receive random treatment allocation.



Enrollment: 659
Study Start Date: July 2000
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (doxorubicin, cisplatin, filgrastim, pegfilgrastim)
Patients receive doxorubicin IV over 30 minutes immediately followed by cisplatin IV over 1 hour on day 1. Patients also receive filgrastim (G-CSF) SC or pegfilgrastim on days 2-11.
Drug: Doxorubicin Hydrochloride
Given IV
Drug: Cisplatin
Given IV
Biological: Filgrastim
Given SC
Other Names:
  • G-CSF
  • Nivestim
  • r-metHuG-CSF
Biological: Pegfilgrastim
Given SC
Other Names:
  • Filgrastim SD-01
  • GCSF-SD01
  • Neulasta
Experimental: Arm II (doxorubicin, cisplatin, paclitaxel, filgrastim)
Patients receive doxorubicin and cisplatin as in arm I, paclitaxel IV over 3 hours on day 2, and G-CSF SC or pegfilgrastim on days 3-12. Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: Doxorubicin Hydrochloride
Given IV
Drug: Cisplatin
Given IV
Biological: Filgrastim
Given SC
Other Names:
  • G-CSF
  • Nivestim
  • r-metHuG-CSF
Biological: Pegfilgrastim
Given SC
Other Names:
  • Filgrastim SD-01
  • GCSF-SD01
  • Neulasta
Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • TAX

Detailed Description:

OBJECTIVES:

I. Compare survival and progression-free survival in patients with stage III endometrial carcinoma treated with tumor volume-directed pelvic radiotherapy with or without paraaortic radiotherapy followed by cisplatin and doxorubicin with or without paclitaxel.

II. Compare short and long-term toxic effects of these treatment regimens in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to radiotherapy field (pelvic vs extended field). Within 8 weeks after surgery, patients receive tumor volume-directed pelvic radiotherapy with or without paraaortic nodal radiotherapy once daily for 5 consecutive days for up to 16 weeks after surgery. Within 8 weeks of completing radiotherapy, patients are randomized to 1 of 2 chemotherapy treatment arms.

Arm I: Patients receive doxorubicin IV over 30 minutes immediately followed by cisplatin IV over 1 hour on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) or pegfilgrastim on days 2-11.

Arm II: Patients receive doxorubicin and cisplatin as in arm I, paclitaxel IV over 3 hours on day 2, and G-CSF SC or pegfilgrastim on days 3-12. Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 614 patients (307 per treatment arm) will be accrued for this study within 5.2 years.

  Eligibility

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

Inclusion Criteria:

  • Histologically confirmed advanced endometrial carcinoma with any histology, including:

    • Clear cell and serous papillary carcinoma
  • Surgical stage III disease, including:

    • Positive adnexa
    • Tumor invading the serosa
    • Positive pelvic and/or paraaortic nodes
    • Involvement of bowel mucosa
    • Intraabdominal metastases
    • Positive pelvic washings
    • Vaginal involvement within the radiation port
  • Must have had prior surgery, including hysterectomy and bilateral salpingo-oophorectomy

    • Tumor maximally debulked to a maximum residual diameter of no greater than 2 cm
    • Paraaortic lymph node sampling allowed

      • If positive, must have negative chest CT scan
  • No recurrent disease
  • No parenchymal liver metastases
  • No disease outside the abdomen
  • Performance status - GOG 0-2
  • At least 3 months
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Bilirubin no greater than 1.5 times normal
  • SGOT/SGPT no greater than 3 times normal
  • Alkaline phosphatase no greater than 3 times normal
  • Creatinine no greater than 1.6 mg/dL
  • LVEF at least 50% within 6 months of study entry
  • No other prior or concurrent malignancy within the past 5 years except adequately treated nonmelanoma skin cancer
  • No serious comorbid illness that would preclude study participation
  • No prior chemotherapy
  • See Disease Characteristics
  • No prior pelvic or abdominal radiotherapy
  • No prior radiotherapy for prior malignancy
  • See Disease Characteristics
  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: NCT00006011

Locations
United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Gynecologic Oncology Group
Eastern Cooperative Oncology Group
Investigators
Principal Investigator: Howard Homesley Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00006011     History of Changes
Other Study ID Numbers: GOG-0184, NCI-2012-02350, ECOG-G0184, RTOG-EN0130, CDR0000068020, GOG-0184, GOG-0184, U10CA027469
Study First Received: July 5, 2000
Results First Received: May 20, 2014
Last Updated: April 30, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Clear Cell
Carcinoma, Adenosquamous
Carcinoma, Endometrioid
Cystadenocarcinoma, Serous
Uterine Neoplasms
Adnexal Diseases
Carcinoma
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
Doxorubicin
Lenograstim
Liposomal doxorubicin
Paclitaxel
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on May 29, 2015