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Combination Chemotherapy With or Without Surgery in Treating Patients With Stage III Ovarian Epithelial Cancer

2013年7月8日更新者：Gynecologic Oncology Group

A PHASE III RANDOMIZED STUDY OF CISPLATIN (NSC #119875) AND TAXOL (PACLITAXEL) (NSC #125973) WITH INTERVAL SECONDARY CYTOREDUCTION VERSUS CISPLATIN AND PACLITAXEL IN PATIENTS WITH SUBOPTIMAL STAGE III & IV EPITHELIAL OVARIAN CARCINOMA

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or combining chemotherapy with surgery may kill more tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy consisting of paclitaxel and cisplatin with or without surgery in treating patients with stage III ovarian epithelial cancer.

研究概览

地位

完全的

条件

卵巢癌

干预/治疗

详细说明

OBJECTIVES: I. Determine whether secondary cytoreductive surgery improves the progression-free interval and survival in patients with suboptimally resected stage III ovarian epithelial carcinoma treated with paclitaxel/cisplatin. II. Determine the morbidity of secondary cytoreductive surgery in these patients. III. Assess prospectively the quality of life (QOL) of these patients and determine whether secondary cytoreductive surgery affects QOL.

OUTLINE: Randomized study. Following treatment on Regimen A, patients with stable or objective response are randomized to Arms I and II. Regimen A: 2-Drug Combination Chemotherapy. Paclitaxel (Bristol-Myers), Taxol, NSC-125973; Cisplatin, CDDP, NSC-119875. Arm I: Surgery followed by 2-Drug Combination Chemotherapy. Laparotomy with resection of residual disease; followed by Taxol/CDDP. Arm II: 2-Drug Combination Chemotherapy. Taxol; CDDP.

PROJECTED ACCRUAL: Approximately 470 patients will be entered over 20 months to provide 400 evaluable patients.

研究类型

介入性

注册 (预期的)

470

阶段

第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

美国
- Alabama
  - Birmingham、Alabama、美国、35294
    - University of Alabama Comprehensive Cancer Center
- Arizona
  - Phoenix、Arizona、美国、85006-2726
    - CCOP - Greater Phoenix
- California
  - Los Angeles、California、美国、90033-0800
    - USC/Norris Comprehensive Cancer Center
  - Los Angeles、California、美国、90095-1781
    - Jonsson Comprehensive Cancer Center, UCLA
  - Orange、California、美国、92868
    - Chao Family Comprehensive Cancer Center
  - Palo Alto、California、美国、94304
    - Women's Cancer Center
  - Stanford、California、美国、94305-5408
    - Stanford University Medical Center
- Colorado
  - Denver、Colorado、美国、80262
    - University of Colorado Cancer Center
- District of Columbia
  - Washington、District of Columbia、美国、20307-5000
    - Walter Reed Army Medical Center
  - Washington、District of Columbia、美国、20007
    - Lombardi Cancer Center, Georgetown University
- Florida
  - Tampa、Florida、美国、33612
    - H. Lee Moffitt Cancer Center and Research Institute
- Georgia
  - Atlanta、Georgia、美国、30322
    - Emory University Hospital - Atlanta
- Hawaii
  - Honolulu、Hawaii、美国、96813
    - MBCCOP - Hawaii
- Illinois
  - Chicago、Illinois、美国、60612
    - Rush-Presbyterian-St. Luke's Medical Center
- Indiana
  - Indianapolis、Indiana、美国、46202-5265
    - Indiana University Cancer Center
- Iowa
  - Iowa City、Iowa、美国、52242
    - University of Iowa Hospitals and Clinics
- Kentucky
  - Lexington、Kentucky、美国、40536-0084
    - Albert B. Chandler Medical Center, University of Kentucky
- Maryland
  - Baltimore、Maryland、美国、21231
    - Johns Hopkins Oncology Center
- Massachusetts
  - Worcester、Massachusetts、美国、01655
    - University of Massachusetts Memorial Medical Center
- Michigan
  - Ann Arbor、Michigan、美国、48106
    - CCOP - Ann Arbor Regional
  - Detroit、Michigan、美国、48201
    - Barbara Ann Karmanos Cancer Institute
- Minnesota
  - Minneapolis、Minnesota、美国、55455
    - University of Minnesota Cancer Center
- Mississippi
  - Jackson、Mississippi、美国、39216-4505
    - University of Mississippi Medical Center
- Missouri
  - Saint Louis、Missouri、美国、63110
    - Washington University School of Medicine
- New Jersey
  - Camden、New Jersey、美国、08103
    - Cooper Hospital/University Medical Center
  - Morristown、New Jersey、美国、07962-1956
    - Morristown Memorial Hospital
- New York
  - Albany、New York、美国、12208
    - Cancer Center of Albany Medical Center
  - Brooklyn、New York、美国、11203
    - State University of New York Health Science Center at Brooklyn
  - Manhasset、New York、美国、11030
    - North Shore University Hospital
  - New York、New York、美国、10021
    - Memorial Sloan-Kettering Cancer Center
  - Rochester、New York、美国、14642
    - University of Rochester Cancer Center
  - Stony Brook、New York、美国、11790-7775
    - State University of New York Health Sciences Center - Stony Brook
- North Carolina
  - Chapel Hill、North Carolina、美国、27599-7295
    - Lineberger Comprehensive Cancer Center, UNC
  - Durham、North Carolina、美国、27710
    - Duke Comprehensive Cancer Center
  - Winston-Salem、North Carolina、美国、27157-1082
    - Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
- Ohio
  - Cincinnati、Ohio、美国、45219
    - Barrett Cancer Center, The University Hospital
  - Cleveland、Ohio、美国、44195
    - Cleveland Clinic Taussig Cancer Center
  - Cleveland、Ohio、美国、44106-5065
    - Ireland Cancer Center
  - Columbus、Ohio、美国、43210
    - Arthur G. James Cancer Hospital - Ohio State University
- Oklahoma
  - Oklahoma City、Oklahoma、美国、73190
    - University of Oklahoma College of Medicine
- Oregon
  - Portland、Oregon、美国、97213
    - CCOP - Columbia River Program
- Pennsylvania
  - Abington、Pennsylvania、美国、19001
    - Abington Memorial Hospital
  - Hershey、Pennsylvania、美国、17033
    - Milton S. Hershey Medical Center
  - Philadelphia、Pennsylvania、美国、19111
    - Fox Chase Cancer Center
  - Philadelphia、Pennsylvania、美国、19104
    - University of Pennsylvania Cancer Center
  - Philadelphia、Pennsylvania、美国、19107
    - Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
- South Carolina
  - Charleston、South Carolina、美国、29425-0721
    - Medical University of South Carolina
  - Spartanburg、South Carolina、美国、29303
    - CCOP - Upstate Carolina
- Tennessee
  - Memphis、Tennessee、美国、38117
    - CCOP - Baptist Cancer Institute
  - Nashville、Tennessee、美国、37203
    - Brookview Research, Inc.
- Texas
  - Dallas、Texas、美国、75235-9154
    - Simmons Cancer Center - Dallas
  - Houston、Texas、美国、77030-4009
    - University of Texas - MD Anderson Cancer Center
- Virginia
  - Charlottesville、Virginia、美国、22908
    - Cancer Center, University of Virginia HSC
- Washington
  - Seattle、Washington、美国、98195-6043
    - University of Washington Medical Center
  - Tacoma、Washington、美国、98405
    - Tacoma General Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

孩子
成人
年长者

接受健康志愿者

不

有资格学习的性别

女性

描述

DISEASE CHARACTERISTICS: Histologically confirmed primary ovarian epithelial cancer Stage III disease, i.e.: Greater than 1 cm residual intraperitoneal disease following exploratory laparotomy with maximum debulking Laparoscopic resection alone insufficient The following histologies are eligible: Serous adenocarcinoma Transitional cell carcinoma Mucinous adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed epithelial carcinoma Adenocarcinoma Endometrioid tumor Adenocarcinoma NOS Malignant Brenner's tumor No unclassified ovarian cancer (i.e., unexplored tumors thought to be of ovarian origin or tumors not verified as arising from ovarian stroma) No borderline (grade 0) or "probably malignant" carcinoma Measurable disease preferred Patients eligible for this protocol are also eligible for protocol GOG-136

PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Hematopoietic: WBC at least 3,000/mm3 Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no more than 1.5 times normal ALT, AST, and GGT no more than 3 times normal Alkaline phosphatase no more than 3 times normal LDH no more than 3 times normal Renal: Creatinine no more than 2.0 mg/dL Cardiovascular: No history of congestive heart failure No myocardial infarction within 6 months No unstable angina Other: No septicemia or severe infection No acute hepatitis No severe gastrointestinal bleeding No second malignancy within 5 years except nonmelanomatous skin cancer Not pregnant or nursing Effective contraception required of fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics No more than 6 weeks since staging surgery

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Gynecologic Oncology Group

合作者

National Cancer Institute (NCI)

调查人员

学习椅：Peter G. Rose, MD、The Cleveland Clinic

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

1994年6月1日

初级完成 (实际的)

2004年12月1日

研究注册日期

首次提交

1999年11月1日

首先提交符合 QC 标准的

2004年5月4日

首次发布 (估计)

2004年5月5日

研究记录更新

最后更新发布 (估计)

2013年7月9日

上次提交的符合 QC 标准的更新

2013年7月8日

最后验证

2010年5月1日