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Spots Global Cancer Trial Database for Combination Chemotherapy Regimens in Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

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Trial Identification

Brief Title: Combination Chemotherapy Regimens in Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

Official Title: A Phase III Study of Cisplatin Plus Topotecan Followed by Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Carboplatin as First Line Chemotherapy in Women With Newly Diagnosed Advanced Epithelial Ovarian Cancer

Study ID: NCT00028743

Study Description

Brief Summary: 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 and giving the drugs in different combinations may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating ovarian epithelial, primary peritoneal, or fallopian tube cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of different combination chemotherapy regimens in treating patients who have stage IIB, stage III, or stage IV ovarian epithelial cancer , primary peritoneal cancer, or fallopian tube cancer.

Detailed Description: OBJECTIVES: * Compare the efficacy of cisplatin and topotecan followed by paclitaxel and carboplatin vs paclitaxel and carboplatin only, in terms of time to disease progression, in patients with newly diagnosed stage IIB-IV ovarian epithelial, primary peritoneal, or fallopian tube cancer. * Compare the overall survival of patients treated with these regimens. * Compare the clinical objective response rates in patients with measurable disease at baseline treated with these regimens. * Compare the toxic effects of these regimens in these patients. * Compare the CA 125 normalization rates in patients treated with these regimens. * Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, age (65 years and under vs over 65 years), and pre-randomization surgery (no debulking vs debulking with macroscopic residual disease less than 1 cm vs debulking with macroscopic residual disease 1 cm or greater vs debulking with no macroscopic residual disease). Patients are randomized to one of two treatment arms. * Arm I: Patients receive cisplatin IV over 60 minutes on day 1 and topotecan IV over 30 minutes on days 1-5 of courses 1-4 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 of courses 5-8. * Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 of courses 1-8. In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Planned interval debulking surgery should occur after course 3 or 4. Quality of life is assessed at baseline; on day 1 of courses 3, 5, and 7; at the end of the last course; and at 3 and 6 months after study treatment completion. Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 800 patients (400 per treatment arm) will be accrued for this study within 2 years.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Tom Baker Cancer Centre, Calgary, Alberta, Canada

Cross Cancer Institute, Edmonton, Alberta, Canada

BCCA - Cancer Centre for the Southern Interior, Kelowna, British Columbia, Canada

Lions Gate Hospital, North Vancouver, British Columbia, Canada

BCCA - Fraser Valley Cancer Centre, Surrey, British Columbia, Canada

BCCA - Vancouver Cancer Centre, Vancouver, British Columbia, Canada

CancerCare Manitoba, Winnipeg, Manitoba, Canada

The Moncton Hospital, Moncton, New Brunswick, Canada

Atlantic Health Sciences Corporation, Saint John, New Brunswick, Canada

Dr. H. Bliss Murphy Cancer Centre, St. John's, Newfoundland and Labrador, Canada

QEII Health Sciences Center, Halifax, Nova Scotia, Canada

Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada

Cancer Centre of Southeastern Ontario at Kingston, Kingston, Ontario, Canada

Grand River Regional Cancer Centre, Kitchener, Ontario, Canada

London Regional Cancer Program, London, Ontario, Canada

Ottawa Health Research Institute - General Division, Ottawa, Ontario, Canada

Niagara Health System, St. Catharines, Ontario, Canada

Northeast Cancer Center Health Sciences, Sudbury, Ontario, Canada

Thunder Bay Regional Health Science Centre, Thunder Bay, Ontario, Canada

Univ. Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada

Windsor Regional Cancer Centre, Windsor, Ontario, Canada

PEI Cancer Treatment Centre,Queen Elizabeth Hospital, Charlottetown, Prince Edward Island, Canada

CHUM - Hopital Notre-Dame, Montreal, Quebec, Canada

Hopital du Sacre-Coeur de Montreal, Montreal, Quebec, Canada

CHUQ-Pavillon Hotel-Dieu de Quebec, Quebec City, Quebec, Canada

Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec, Canada

Allan Blair Cancer Centre, Regina, Saskatchewan, Canada

Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada

Contact Details

Name: Paul J. Hoskins, MD

Affiliation: British Columbia Cancer Agency

Role: STUDY_CHAIR

Name: Ignace B. Vergote, MD, PhD

Affiliation: University Hospital, Gasthuisberg

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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