Clinical trial NCT00002895: Early Chemotherapy Based on CA 125 Level Alone Compared With Delayed Chemotherapy in Treating Patients With Recurrent Ovarian Epithelial , Fallopian Tube, or Primary Peritoneal Cancer
Official title: A Randomised Trial in Relapsed Ovarian Cancer: Early Treatment Based on CA 125 Levels Alone Vs. Delayed Treatment Based On Conventional Clinical Indicators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Keywords: recurrent ovarian epithelial cancer
primary peritoneal cavity cancer
fallopian tube cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: European Organisation for Research and Treatment of Cancer - EORTC
First posted: 2003-01-27
Enrollment: 1400
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: RATIONALE: It is not yet known if treatment for recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer is more effective if it is begun when blood levels of CA 125 become elevated rather than waiting for other indicators of disease recurrence.

PURPOSE: This randomized phase III trial is studying early chemotherapy based on blood levels of CA 125 alone to see how well it works compared to chemotherapy based on conventional clinical indicators in patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer.

Detailed description: OBJECTIVES:

* Compare the benefit of early chemotherapy based on CA 125 level only vs chemotherapy based on conventional clinical indicators in patients with relapsed ovarian epithelial, fallopian tube, or primary peritoneal cancer.
* Compare the overall survival of patients treated with these regimens.
* Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients whose CA 125 levels rise to more than two times the upper limit of normal are randomized to one of two treatment arms.

* Arm I: The clinician is informed of the initial rise in CA 125 level. A confirmatory test is performed immediately. Within 4 weeks of the initial CA 125 elevation, patients with a second confirmed elevation receive treatment for recurrent disease according to standard local practice. Patients with a normal CA 125 on the confirmatory test receive no treatment until clinically indicated.
* Arm II: The clinician is blinded to the CA 125 results. Patients undergo normal monitoring. When clinically indicated, patients commence treatment according to standard local practice.

Quality of life is assessed at baseline, at each follow-up visit, and, if treatment is instituted, before each chemotherapy course.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 1,400 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer

  * Achieved complete remission with normal CA 125 after first-line platinum-containing chemotherapy
* Prior participation in the following clinical trials is allowed:

  * MRC-ICON2 (carboplatin vs cyclophosphamide, doxorubicin, and cisplatin for advanced disease)
  * MRC-ICON3 (paclitaxel with carboplatin in first-line therapy for advanced disease)
  * MRC-ICON5 (carboplatin and paclitaxel vs triplet and sequential doublet combinations of chemotherapy)
* No prior participation in MRC-ICON1 (adjuvant chemotherapy for early-stage ovarian cancer)

PATIENT CHARACTERISTICS:

Age:

* Not specified

Performance status:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No prior or concurrent malignancy within the past 5 years that is likely to preclude study treatment or comparisons except for nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* See Disease Characteristics

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified

Primary outcomes:
measure: Benefit of early chemotherapy
measure: Overall survival
measure: Quality of life
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Kaiser Franz Josef Hospital
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Brussels
country: Belgium
facility: Academisch Ziekenhuis der Vrije Universiteit Brussel
city: Kortrijk
country: Belgium
facility: Cazk Groeninghe - Campus Maria's Voorzienigheid
city: Caen
country: France
facility: Centre Regional Francois Baclesse
city: Dublin
country: Ireland
facility: Coombe Women's Hospital
city: Dublin
country: Ireland
facility: St. James' Hospital
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
city: 's-Gravenhage
country: Netherlands
facility: Leyenburg Ziekenhuis
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum at University of Amsterdam
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Nijmegen
country: Netherlands
facility: Nijmegen Cancer Center at Radboud University Medical Center
city: Rotterdam
country: Netherlands
facility: Daniel Den Hoed Cancer Center at Erasmus Medical Center
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Zwolle
country: Netherlands
facility: Isala Klinieken - locatie Sophia
city: Coimbra
country: Portugal
facility: Hospitais da Universidade de Coimbra (HUC)
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
city: Barcelona
country: Spain
facility: Institut d'Oncologia Corachan
city: Madrid
country: Spain
facility: Hospital Universitario San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre at Mount Vernon Hospital
state: England
Study officials:
affiliation: Mount Vernon Cancer Centre at Mount Vernon Hospital
name: Gordon J.S. Rustin, MD
affiliation: University Medical Center Rotterdam at Erasmus Medical Center
name: M. E.L. van der Burg, MD, PhD
References:
citation: Markman M, Petersen J, Belland A, Burg K. CA-125 monitoring in ovarian cancer: patient survey responses to the results of the MRC/EORTC CA-125 Surveillance Trial. Oncology. 2010;78(1):1-2. doi: 10.1159/000292352. Epub 2010 Mar 6. No abstract available.
citation: Rustin GJ, van der Burg ME, Griffin CL, Guthrie D, Lamont A, Jayson GC, Kristensen G, Mediola C, Coens C, Qian W, Parmar MK, Swart AM; MRC OV05; EORTC 55955 investigators. Early versus delayed treatment of relapsed ovarian cancer (MRC OV05/EORTC 55955): a randomised trial. Lancet. 2010 Oct 2;376(9747):1155-63. doi: 10.1016/S0140-6736(10)61268-8.
citation: Rustin GJ, van der Burg ME: A randomized trial in ovarian cancer (OC) of early treatment of relapse based on CA125 level alone versus delayed treatment based on conventional clinical indicators (MRC OV05/EORTC 55955 trials). [Abstract] J Clin Oncol 27 (Suppl 18): A-1, 2009.