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

Endometrial Adenocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006011
• Other study ID #: GOG-0184
• Secondary ID: NCI-2012-02350EC
• Status: Completed
• Phase: Phase 3
• First received: July 5, 2000
• Last updated: April 30, 2015
• Start date: July 2000

Study information

• Verified date: April 2015
• Source: Gynecologic Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 659
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Carcinoma, Adenosquamous
• Carcinoma, Endometrioid
• Endometrial Adenocarcinoma
• Endometrial Adenosquamous Carcinoma
• Endometrial Clear Cell Adenocarcinoma
• Endometrial Endometrioid Adenocarcinoma, Variant With Squamous Differentiation
• Endometrial Serous Adenocarcinoma
• Stage III Uterine Corpus Cancer
• Uterine Neoplasms

Intervention

Drug:
• Doxorubicin Hydrochloride
Given IV
• Cisplatin
Given IV

Biological:
• Filgrastim
Given SC
• Pegfilgrastim
Given SC

Drug:
• Paclitaxel
Given IV

Locations

Country	Name	City	State
United States	Gynecologic Oncology Group	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Gynecologic Oncology Group	Eastern Cooperative Oncology Group, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-Free Survival of Eligible Patients Who Received a Random Treatment Allocation.	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.	study entry up to 5 years post treatment	No