Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian, Peritoneal, or Fallopian Tube Cancer - Full Text View

Sponsor:	European Organization for Research and Treatment of Cancer
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003636

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining surgery with chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy before surgery is more effective than chemotherapy after surgery in treating ovarian, peritoneal, or fallopian tube cancer.

PURPOSE: This randomized phase III trial is studying chemotherapy given before surgery to see how well it works compared to chemotherapy given after surgery with or without additional surgery in treating patients with stage III or stage IV ovarian cancer, peritoneal cancer, or fallopian tube cancer.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Randomized Phase III Study Comparing Upfront Debulking Surgery Versus Neo-Adjuvant Chemotherapy in Patients With Stage IIIC or IV Epithelial Ovarian Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer Surgery

Drug Information available for: Cisplatin Carboplatin

U.S. FDA Resources

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

Primary Outcome Measures:

Overall survival as measured by Kaplan Meier every 3 months for 2 years, every 6 months for 3 years, and then annually [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival as measured by Kaplan Meier and RECIST every 3 months for 2 years, every 6 months for 3 years, and then annually [ Designated as safety issue: No ]
Health-related quality of life as measured by Quality of Life Questionnaire-C30 after courses 1, 3 and 6, then at 6 and 12 months [ Designated as safety issue: No ]
Toxicity as measured by NCIC Common Toxicity Criteria v2.0 within 4 weeks of surgery [ Designated as safety issue: Yes ]

Estimated Enrollment:	704
Study Start Date:	September 1998

Detailed Description:

OBJECTIVES:

Compare the overall survival and progression-free survival in patients with stage IIIC or IV ovarian epithelial, peritoneal, or fallopian tube carcinoma treated with neoadjuvant chemotherapy followed by interval debulking surgery versus upfront cytoreductive surgery followed by chemotherapy with or without interval debulking surgery.
Compare the quality of life of patients treated with these regimens.
Compare the different treatment complications in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, method of biopsy, stage, largest tumor size before surgery, and intent to also randomize on EORTC-55012. Patients are randomized to one of two treatment arms.

Arm I: Patients undergo upfront maximal cytoreductive surgery followed by cisplatin or carboplatin IV every 3 weeks for 3 courses. Patients with non-optimal primary debulking may undergo interval debulking surgery at the physician's discretion. All patients then receive an additional 3 courses of the same regimen of chemotherapy.
Arm II: Patients receive chemotherapy as in arm I. Patients with stable or responding disease undergo interval debulking surgery followed by an additional 3 courses of the same regimen of chemotherapy.

Second-look surgery is allowed for both arms if clinically indicated.

Quality of life (QOL) is assessed prior to treatment, after the third and sixth course of chemotherapy, and at 6 and 12 months after study. Patients who are also randomized on EORTC-55012 follow the QOL assessment schedule for EORTC-55012 only.

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

PROJECTED ACCRUAL: A total of 704 patients will be accrued for this study within 4 years.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically proven stage IIIC or IV ovarian epithelial carcinoma, peritoneal carcinoma, or fallopian tube carcinoma
- If biopsy is not available, evidence of adenocarcinoma by fine needle aspiration allowed if all of the following are true:
  - Presence of pelvic ovarian mass
  - Omental cake or other metastasis larger than 2 cm in the upper abdomen and/or regional lymph node metastasis
  - CA 125/carcinoembryonic antigen ratio greater than 25 (if ratio less than 25, barium enema or colonoscopy AND gastroscopy or radiological examination of the stomach must be negative for primary tumor)
  - Normal mammography (if CA 125/carcinoembryonic antigen ratio less than 25)
Tumor greater than 2 cm, excluding ovaries, on laparoscopy or CT scan
No brain or leptomeningeal metastases

PATIENT CHARACTERISTICS:

Age:

Not specified

Performance status:

WHO 0-2

Life expectancy:

Not specified

Hematopoietic:

WBC greater than 3,000/mm^3
Platelet count greater than 100,000/mm^3

Hepatic:

Bilirubin less than 1.25 times upper limit of normal (ULN)

Renal:

Creatinine less than 1.25 times ULN

Other:

No other serious disabling diseases contraindicating primary cytoreductive surgery or primary platin-based chemotherapy
No other prior primary malignancies except carcinoma in situ of the cervix or basal cell carcinoma of the skin
No psychological, familial, sociological, or geographical condition potentially preventing protocol compliance or follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

No other prior procedures except diagnostic biopsy by laparotomy or laparoscopy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003636

Show 65 Study Locations

Sponsors and Collaborators

European Organization for Research and Treatment of Cancer

Investigators

Investigator:

Ignace B. Vergote, MD, PhD

U.Z. Gasthuisberg

More Information

Additional Information:

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

Publications:

Fruehauf JP, Yu I, Parker R: In vitro drug response and biomarker profiles for ovarian cancer specimens obtained at initial debulking or after neoadjuvant chemotherapy (EORTC 55971). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2177, 2002.

Study ID Numbers:	CDR0000066721, EORTC-55971
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00003636 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
fallopian tube cancer
peritoneal cavity cancer

Additional relevant MeSH terms:

Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Neoplasms by Site
Cisplatin
Therapeutic Uses
Peritoneal Diseases
Endocrine Gland Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms

Genital Neoplasms, Female
Endocrine System Diseases
Carboplatin
Abdominal Neoplasms
Fallopian Tube Neoplasms
Pharmacologic Actions
Adnexal Diseases
Fallopian Tube Diseases
Neoplasms
Digestive System Diseases
Radiation-Sensitizing Agents
Peritoneal Neoplasms

ClinicalTrials.gov processed this record on November 25, 2009