Timing of Surgery and Chemotherapy in Treating Patients With Newly Diagnosed Advanced Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer - Full Text View

Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed; giving chemotherapy after surgery may kill any remaining tumor cells. It is not yet known whether giving chemotherapy before and after surgery is more effective than giving chemotherapy after surgery in treating ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer.

PURPOSE: This randomized phase II/III trial is studying how well giving chemotherapy before and after surgery works and compares it to giving chemotherapy after surgery alone in treating patients with newly diagnosed advanced ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer.

Condition	Intervention	Phase
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer	Drug: carboplatin Drug: paclitaxel Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy	Phase II Phase III

MedlinePlus related topics:

Cancer Ovarian Cancer

ChemIDplus related topics:

Carboplatin Paclitaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control

Official Title:	A Randomized Feasibility Trial to Determine the Impact of Timing of Surgery and Chemotherapy in Newly Diagnosed Patients With Advanced Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Overall survival at 3 years [ Designated as safety issue: No ]
Progression-free survival [ Designated as safety issue: No ]
Quality of life by Quality of Life Questionnaire Core 30 Items (QLQ-C30) and QLQ-ovarian cancer (QLQ-OV28) [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	September 2003

Detailed Description:

OBJECTIVES:

Determine the feasibility of a randomized trial to determine the impact of the timing of surgery and chemotherapy in patients with newly diagnosed advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer.

OUTLINE: This is a randomized, pilot, multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm I (primary surgery): Patients undergo radical surgery. Within 6 weeks after primary surgery, patients receive chemotherapy comprising carboplatin alone or in combination with paclitaxel or another chemotherapy agent on day 1. Chemotherapy repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients may undergo interval debulking surgery after the third course of chemotherapy.
Arm II (neoadjuvant chemotherapy): Patients receive chemotherapy as in arm I for 3 courses. Within 3 weeks after chemotherapy, patients undergo radical surgery. Within 6 weeks after surgery, patients receive an additional 3 courses of chemotherapy as in arm I.

Patients are followed at 9 months after randomization, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 100-150 patients will be accrued for this study within 18 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Newly diagnosed advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer
Clinical and imaging evidence of a pelvic mass with extrapelvic metastases within the past 4 weeks
Serum CA 125/CEA ratio > 25
Plans to receive carboplatin-based chemotherapy

PATIENT CHARACTERISTICS:

Age

Adult

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

Considered fit to undergo protocol treatment and follow-up
No other prior or concurrent malignancy that would preclude study treatment or comparisons

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

See Disease Characteristics

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075712

Show 70 Study Locations

Sponsors and Collaborators

Royal College of Obstetricians and Gynecologists

Investigators


Principal Investigator:	Sean Kehoe	Oxford Radcliffe Hospital

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000347463, RCOG-MRC-CHORUS, EU-20350, ISRCTN74802813
First Received:	January 9, 2004
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00075712
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

peritoneal cavity cancer

stage III ovarian epithelial cancer

stage IV ovarian epithelial cancer

fallopian tube cancer

Study placed in the following topic categories:

Ovarian cancer

Ovarian Neoplasms

Gonadal Disorders

Genital Neoplasms, Female

Endocrine System Diseases

Urogenital Neoplasms

Carboplatin

Ovarian Diseases

Ovarian epithelial cancer

Fallopian Tube Neoplasms

Carcinoma

Fallopian Tube Diseases

Genital Diseases, Female

Paclitaxel

Endocrinopathy

Fallopian tube cancer

Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Mitosis Modulators

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Phytogenic

Pharmacologic Actions

Adnexal Diseases

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Royal College of Obstetricians and Gynecologists
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00075712