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Combination Chemotherapy in Treating Patients With Primary Peritoneal or Stage III Epithelial Ovarian Cancer

24 mai 2013 mis à jour par: Gynecologic Oncology Group

A Phase III Randomized Trial of Intravenous Paclitaxel and Cisplatin Versus Intravenous Paclitaxel, Intraperitoneal Cisplatin and Intraperitoneal Paclitaxel in Patients With Optimal Stage III Epithelial Ovarian Carcinoma or Primary Peritoneal 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 and giving drugs in different ways may kill more tumor cells. It is not yet known whether intravenous two-drug combination chemotherapy is more effective than intravenous and intraperitoneal infusions of three-drug combination chemotherapy for treating primary peritoneal or stage III epithelial ovarian cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of intravenous two-drug combination chemotherapy with intravenous and intraperitoneal three-drug combination chemotherapy in treating patients who have primary peritoneal or stage III epithelial ovarian cancer.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

OBJECTIVES: I. Compare pathological response, recurrence-free interval, and survival in patients with optimal stage III epithelial ovarian cancer or primary peritoneal carcinoma receiving intravenous (IV) paclitaxel and cisplatin vs IV paclitaxel and intraperitoneal (IP) cisplatin plus IP paclitaxel. II. Compare the toxic effects and complications of these 2 treatment regimens in these patients. III. Determine the frequency and prognostic significance of BRCA1 and BRCA2 mutations in these patients. IV. Determine the effect of non-genetic risk factors on the course of disease in BRCA1- and BRCA2-related ovarian cancer or primary peritoneal carcinoma. V. Compare the quality of life of these patients receiving these treatments.

OUTLINE: This is a randomized study. Patients are stratified according to gross residual disease (present vs absent) and whether second-look surgery will be performed at the end of treatment (yes vs no). Blood is drawn for BRCA mutation analysis and DNA extraction before the start of chemotherapy, but after randomization. Patients are randomized to one of two treatment arms. Patients in arm I receive IV paclitaxel by 24-hour infusion on day 1 followed by IV cisplatin on day 2. Patients in arm II receive IV paclitaxel by 24-hour infusion on day 1 followed by intraperitoneal (IP) cisplatin on day 2, plus IP paclitaxel on day 8. Treatment for both arms repeats every 3 weeks for a total of 6 treatment courses. Following chemotherapy, second look surgery is performed if selected by the patient. Quality-of-life assessments are performed prior to randomization, prior to course 4, 3-6 weeks after the completion of course 6 and prior to second look surgery if selected, 6 months after treatment is completed, and 12 months after treatment is completed. Patients are followed every 3 months for 2 years, then every 6 months thereafter.

PROJECTED ACCRUAL: Approximately 384 patients will be accrued for this study within 16 months.

Type d'étude

Interventionnel

Inscription (Anticipé)

384

Phase

Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 4N2
    - Tom Baker Cancer Center - Calgary
États-Unis
- Alabama
  - Birmingham, Alabama, États-Unis, 35294
    - University of Alabama Comprehensive Cancer Center
- Arizona
  - Phoenix, Arizona, États-Unis, 85006-2726
    - CCOP - Greater Phoenix
- California
  - Los Angeles, California, États-Unis, 90033-0800
    - USC/Norris Comprehensive Cancer Center
  - Los Angeles, California, États-Unis, 90095-1781
    - Jonsson Comprehensive Cancer Center, UCLA
  - Orange, California, États-Unis, 92868
    - Chao Family Comprehensive Cancer Center
  - Palo Alto, California, États-Unis, 94304
    - Women's Cancer Center
- Colorado
  - Denver, Colorado, États-Unis, 80262
    - University of Colorado Cancer Center
- District of Columbia
  - Washington, District of Columbia, États-Unis, 20307-5000
    - Walter Reed Army Medical Center
  - Washington, District of Columbia, États-Unis, 20007
    - Lombardi Cancer Center, Georgetown University
- Florida
  - Tampa, Florida, États-Unis, 33612
    - H. Lee Moffitt Cancer Center and Research Institute
- Georgia
  - Atlanta, Georgia, États-Unis, 30322
    - Emory University Hospital - Atlanta
  - Atlanta, Georgia, États-Unis, 30342-1701
    - CCOP - Atlanta Regional
- Hawaii
  - Honolulu, Hawaii, États-Unis, 96813
    - MBCCOP - Hawaii
- Illinois
  - Chicago, Illinois, États-Unis, 60612
    - Rush-Presbyterian-St. Luke's Medical Center
  - Chicago, Illinois, États-Unis, 60637
    - University of Chicago Cancer Research Center
  - Decatur, Illinois, États-Unis, 62526
    - CCOP - Central Illinois
  - Evanston, Illinois, États-Unis, 60201
    - CCOP - Evanston
- Indiana
  - Indianapolis, Indiana, États-Unis, 46202-5265
    - Indiana University Cancer Center
- Iowa
  - Iowa City, Iowa, États-Unis, 52242
    - University of Iowa Hospitals and Clinics
- Kentucky
  - Lexington, Kentucky, États-Unis, 40536-0084
    - Albert B. Chandler Medical Center, University of Kentucky
- Maryland
  - Baltimore, Maryland, États-Unis, 21231
    - Johns Hopkins Oncology Center
  - Bethesda, Maryland, États-Unis, 20892
    - Radiation Oncology Branch
  - Bethesda, Maryland, États-Unis, 20892
    - Medicine Branch
- Massachusetts
  - Worcester, Massachusetts, États-Unis, 01655
    - University of Massachusetts Memorial Medical Center
- Michigan
  - Ann Arbor, Michigan, États-Unis, 48106
    - CCOP - Ann Arbor Regional
  - Detroit, Michigan, États-Unis, 48201
    - Barbara Ann Karmanos Cancer Institute
- Minnesota
  - Minneapolis, Minnesota, États-Unis, 55455
    - University of Minnesota Cancer Center
- Mississippi
  - Jackson, Mississippi, États-Unis, 39216-4505
    - University of Mississippi Medical Center
- Missouri
  - Kansas City, Missouri, États-Unis, 64131
    - CCOP - Kansas City
  - Saint Louis, Missouri, États-Unis, 63110
    - Washington University School of Medicine
- Montana
  - Billings, Montana, États-Unis, 59101
    - CCOP - Montana Cancer Consortium
- Nebraska
  - Omaha, Nebraska, États-Unis, 68131
    - CCOP - Missouri Valley Cancer Consortium
- Nevada
  - Las Vegas, Nevada, États-Unis, 89106
    - CCOP - Southern Nevada Cancer Research Foundation
- New Jersey
  - Camden, New Jersey, États-Unis, 08103
    - Cooper Hospital/University Medical Center
  - Livingston, New Jersey, États-Unis, 07039
    - St. Barnabas Medical Center
  - Morristown, New Jersey, États-Unis, 07962-1956
    - Morristown Memorial Hospital
- New York
  - Albany, New York, États-Unis, 12208
    - Cancer Center of Albany Medical Center
  - Brooklyn, New York, États-Unis, 11203
    - State University of New York Health Science Center at Brooklyn
  - Manhasset, New York, États-Unis, 11030
    - North Shore University Hospital
  - New York, New York, États-Unis, 10021
    - Memorial Sloan-Kettering Cancer Center
  - Rochester, New York, États-Unis, 14642
    - University of Rochester Cancer Center
  - Stony Brook, New York, États-Unis, 11790-7775
    - State University of New York Health Sciences Center - Stony Brook
- North Carolina
  - Chapel Hill, North Carolina, États-Unis, 27599-7295
    - Lineberger Comprehensive Cancer Center, UNC
  - Durham, North Carolina, États-Unis, 27710
    - Duke Comprehensive Cancer Center
  - Winston-Salem, North Carolina, États-Unis, 27157-1082
    - Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
- Ohio
  - Cincinnati, Ohio, États-Unis, 45219
    - Barrett Cancer Center, The University Hospital
  - Cleveland, Ohio, États-Unis, 44195
    - Cleveland Clinic Cancer Center
  - Cleveland, Ohio, États-Unis, 44106-5065
    - Ireland Cancer Center
  - Columbus, Ohio, États-Unis, 43210
    - Arthur G. James Cancer Hospital - Ohio State University
- Oklahoma
  - Oklahoma City, Oklahoma, États-Unis, 73190
    - University of Oklahoma College of Medicine
  - Tulsa, Oklahoma, États-Unis, 74136
    - CCOP - Sooner State
- Oregon
  - Portland, Oregon, États-Unis, 97213
    - CCOP - Columbia River Program
- Pennsylvania
  - Abington, Pennsylvania, États-Unis, 19001
    - Abington Memorial Hospital
  - Hershey, Pennsylvania, États-Unis, 17033
    - Milton S. Hershey Medical Center
  - Philadelphia, Pennsylvania, États-Unis, 19111
    - Fox Chase Cancer Center
  - Philadelphia, Pennsylvania, États-Unis, 19104
    - University of Pennsylvania Cancer Center
  - Philadelphia, Pennsylvania, États-Unis, 19107
    - Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
- South Carolina
  - Charleston, South Carolina, États-Unis, 29425-0721
    - Medical University of South Carolina
  - Spartanburg, South Carolina, États-Unis, 29303
    - CCOP - Upstate Carolina
- Tennessee
  - Memphis, Tennessee, États-Unis, 38117
    - CCOP - Baptist Cancer Institute
  - Nashville, Tennessee, États-Unis, 37203
    - Brookview Research, Inc.
- Texas
  - Dallas, Texas, États-Unis, 75235-9154
    - Simmons Cancer Center - Dallas
  - Houston, Texas, États-Unis, 77030
    - University of Texas - MD Anderson Cancer Center
- Virginia
  - Charlottesville, Virginia, États-Unis, 22908
    - Cancer Center, University of Virginia HSC
- Washington
  - Seattle, Washington, États-Unis, 98195-6043
    - University of Washington Medical Center
  - Tacoma, Washington, États-Unis, 98405
    - Tacoma General Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Enfant
Adulte
Adulte plus âgé

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

DISEASE CHARACTERISTICS: Histologically proven primary peritoneal carcinoma or optimal (no greater than 1 cm residual disease) stage III epithelial ovarian carcinoma with the following epithelial cell types: Serous adenocarcinoma Endometrioid adenocarcinoma Mucinous adenocarcinoma Undifferentiated carcinoma Clear cell adenocarcinoma Mixed epithelial carcinoma Transitional cell carcinoma Malignant Brenner's Tumor Adenocarcinoma NOS Prior surgery for ovarian/peritoneal carcinoma required No epithelial ovarian carcinoma of low malignant potential (borderline carcinoma)

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal No acute hepatitis Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No unstable angina No myocardial infarction within prior 6 months Patients with abnormal cardiac conduction are eligible if disease stable for at least 6 months Other: No septicemia or severe infection No severe gastrointestinal bleeding No other invasive malignancy within past 5 years except nonmelanoma skin cancer Any previous cancer treatment must not contraindicate this protocol therapy

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Objectif principal: Traitement
Répartition: Randomisé

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Gynecologic Oncology Group

Collaborateurs

National Cancer Institute (NCI)

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Farley JH, Tian C, Rose GS, Brown CL, Birrer M, Maxwell GL. Race does not impact outcome for advanced ovarian cancer patients treated with cisplatin/paclitaxel: an analysis of Gynecologic Oncology Group trials. Cancer. 2009 Sep 15;115(18):4210-7. doi: 10.1002/cncr.24482.
Zorn KK, Tian C, McGuire WP, Hoskins WJ, Markman M, Muggia FM, Rose PG, Ozols RF, Spriggs D, Armstrong DK. The prognostic value of pretreatment CA 125 in patients with advanced ovarian carcinoma: a Gynecologic Oncology Group study. Cancer. 2009 Mar 1;115(5):1028-35. doi: 10.1002/cncr.24084.
Armstrong DK, Bundy B, Wenzel L, Huang HQ, Baergen R, Lele S, Copeland LJ, Walker JL, Burger RA; Gynecologic Oncology Group. Intraperitoneal cisplatin and paclitaxel in ovarian cancer. N Engl J Med. 2006 Jan 5;354(1):34-43. doi: 10.1056/NEJMoa052985.
von Gruenigen VE, Huang HQ, Gil KM, Gibbons HE, Monk BJ, Rose PG, Armstrong DK, Cella D, Wenzel L. A comparison of quality-of-life domains and clinical factors in ovarian cancer patients: a Gynecologic Oncology Group study. J Pain Symptom Manage. 2010 May;39(5):839-46. doi: 10.1016/j.jpainsymman.2009.09.022.
Winter WE 3rd, Maxwell GL, Tian C, Carlson JW, Ozols RF, Rose PG, Markman M, Armstrong DK, Muggia F, McGuire WP; Gynecologic Oncology Group Study. Prognostic factors for stage III epithelial ovarian cancer: a Gynecologic Oncology Group Study. J Clin Oncol. 2007 Aug 20;25(24):3621-7. doi: 10.1200/JCO.2006.10.2517.
Barlin JN, Dao F, Bou Zgheib N, Ferguson SE, Sabbatini PJ, Hensley ML, Bell-McGuinn KM, Konner J, Tew WP, Aghajanian C, Chi DS. Progression-free and overall survival of a modified outpatient regimen of primary intravenous/intraperitoneal paclitaxel and intraperitoneal cisplatin in ovarian, fallopian tube, and primary peritoneal cancer. Gynecol Oncol. 2012 Jun;125(3):621-4. doi: 10.1016/j.ygyno.2012.03.027. Epub 2012 Mar 21.
Rubatt JM, Darcy KM, Tian C, Muggia F, Dhir R, Armstrong DK, Bookman MA, Niedernhofer LJ, Deloia J, Birrer M, Krivak TC. Pre-treatment tumor expression of ERCC1 in women with advanced stage epithelial ovarian cancer is not predictive of clinical outcomes: a Gynecologic Oncology Group study. Gynecol Oncol. 2012 May;125(2):421-6. doi: 10.1016/j.ygyno.2012.01.008. Epub 2012 Jan 16.
Tian C, Ambrosone CB, Darcy KM, Krivak TC, Armstrong DK, Bookman MA, Davis W, Zhao H, Moysich K, Gallion H, DeLoia JA. Common variants in ABCB1, ABCC2 and ABCG2 genes and clinical outcomes among women with advanced stage ovarian cancer treated with platinum and taxane-based chemotherapy: a Gynecologic Oncology Group study. Gynecol Oncol. 2012 Mar;124(3):575-81. doi: 10.1016/j.ygyno.2011.11.022. Epub 2011 Nov 21.
Hamilton CA, Miller A, Miller C, Krivak TC, Farley JH, Chernofsky MR, Stany MP, Rose GS, Markman M, Ozols RF, Armstrong DK, Maxwell GL. The impact of disease distribution on survival in patients with stage III epithelial ovarian cancer cytoreduced to microscopic residual: a Gynecologic Oncology Group study. Gynecol Oncol. 2011 Sep;122(3):521-6. doi: 10.1016/j.ygyno.2011.04.041. Epub 2011 Jun 17.
Aletti GD, Nordquist D, Hartmann L, Gallenberg M, Long HJ, Cliby WA. From randomized trial to practice: single institution experience using the GOG 172 i.p. chemotherapy regimen for ovarian cancer. Ann Oncol. 2010 Sep;21(9):1772-1778. doi: 10.1093/annonc/mdq025. Epub 2010 Feb 5.
Darcy KM, Tian C, Ambrosone CB, et al.: A Gynecologic Oncology Group study of associations between polymorphisms in ABC transporter genes (ABCB1, ABCC2, and ABCG2) and outcome in advanced stage epithelial ovarian cancer treated with platinum and taxane chemotherapy. [Abstract] J Clin Oncol 27 (Suppl 15): A-5567, 2009.
Havrilesky LJ, Secord AA, Darcy KM, Armstrong DK, Kulasingam S; Gynecologic Oncology Group. Cost effectiveness of intraperitoneal compared with intravenous chemotherapy for women with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group study. J Clin Oncol. 2008 Sep 1;26(25):4144-50. doi: 10.1200/JCO.2007.13.1961.
Bristow RE, Santillan A, Salani R, Diaz-Montes TP, Giuntoli RL 2nd, Meisner BC, Armstrong DK, Frick KD. Intraperitoneal cisplatin and paclitaxel versus intravenous carboplatin and paclitaxel chemotherapy for Stage III ovarian cancer: a cost-effectiveness analysis. Gynecol Oncol. 2007 Sep;106(3):476-81. doi: 10.1016/j.ygyno.2007.05.043. Epub 2007 Aug 3.
Alberts DS, Delforge A. Maximizing the delivery of intraperitoneal therapy while minimizing drug toxicity and maintaining quality of life. Semin Oncol. 2006 Dec;33(6 Suppl 12):S8-17. doi: 10.1053/j.seminoncol.2006.11.003.
Armstrong DK, Brady MF. Intraperitoneal therapy for ovarian cancer: a treatment ready for prime time. J Clin Oncol. 2006 Oct 1;24(28):4531-3. doi: 10.1200/JCO.2006.06.7140. No abstract available.
Markman M. Clinical efficacy supporting the role of intraperitoneal drug delivery in the primary chemotherapeutic management of small-volume residual advanced ovarian cancer. Semin Oncol. 2006 Dec;33(6 Suppl 12):S3-7. doi: 10.1053/j.seminoncol.2006.11.002.
Singhal P, Lele S. Intraperitoneal chemotherapy for ovarian cancer: where are we now? J Natl Compr Canc Netw. 2006 Oct;4(9):941-6. doi: 10.6004/jnccn.2006.0077.
Baysal BE, DeLoia JA, Willett-Brozick JE, Goodman MT, Brady MF, Modugno F, Lynch HT, Conley YP, Watson P, Gallion HH. Analysis of CHEK2 gene for ovarian cancer susceptibility. Gynecol Oncol. 2004 Oct;95(1):62-9. doi: 10.1016/j.ygyno.2004.07.015.
Armstrong DK, Bundy BN, Baergen R, et al.: Randomized phase III study of intravenous (IV) paclitaxel and cisplatin versus IV paclitaxel, intraperitoneal (IP) cisplatin and IP paclitaxel in optimal stage III epithelial ovarian cancer (OC): a Gynecologic Oncology Group trial (GOG 172). [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-803, 2002.
DeLoia JA, Krivak T, Darcy KM, et al.: Relationship between the C8092A polymorphisms in ERCC1 and clinical outcome in optimally-resected, stage III epithelial ovarian cancer treated with intraperitoneal or intravenous cisplatin and paclitaxel: a Gynecologic Oncology Group study. [Abstract] American Association for Cancer Research: 98th Annual Meeting, April 14-18, 2007, Los Angeles, CA. A-1674, 2007.
Krivak TC, Darcy KM, Tian C, et al.: Relationship between polymorphisms in cordon 118 and C8092A in ERCC1 and clinical outcome in optimally-resected, stage III epithelial ovarian cancer treated with intraperitoneal or intravenous cisplatin and paclitaxel: a Gynecologic Oncology Group study. [Abstract] J Clin Oncol 25 (Suppl 18): A-21050, 733s, 2007.
Krivak TC, Darcy KM, Tian C, Armstrong D, Baysal BE, Gallion H, Ambrosone CB, DeLoia JA; Gynecologic Oncology Group Phase III Trial. Relationship between ERCC1 polymorphisms, disease progression, and survival in the Gynecologic Oncology Group Phase III Trial of intraperitoneal versus intravenous cisplatin and paclitaxel for stage III epithelial ovarian cancer. J Clin Oncol. 2008 Jul 20;26(21):3598-606. doi: 10.1200/JCO.2008.16.1323.
Krivak TC, Tian C, Rose GS, Armstrong DK, Maxwell GL. A Gynecologic Oncology Group Study of serum CA-125 levels in patients with stage III optimally debulked ovarian cancer treated with intraperitoneal compared to intravenous chemotherapy: an analysis of patients enrolled in GOG 172. Gynecol Oncol. 2009 Oct;115(1):81-85. doi: 10.1016/j.ygyno.2009.06.021. Epub 2009 Jul 12.
Krivak T, Darcy K, Tian C, et al.: Relationship between polymorphisms in ERCC1 and clinical outcome in optimally resected stage III epithelial ovarian cancer: a Gynecologic Oncology Group study. [Abstract] Society of Gynecologic Oncologists, 2007 Annual Meeting on Women's Cancer, March 3-7, 2007, San Diego, CA. A-146, 2007.
Seamon LG, Carlson MJ, Richardson DL, et al.: Improved intraperitoneal chemotherapeutic toxicity profile for ovarian cancer: A modification of the taxane-platinum protocol in GOG-172. [Abstract] J Clin Oncol 26 (Suppl 15): A-5583, 2008.
Thrall M, Gallion HH, Kryscio R, Kapali M, Armstrong DK, DeLoia JA. BRCA1 expression in a large series of sporadic ovarian carcinomas: a Gynecologic Oncology Group study. Int J Gynecol Cancer. 2006 Jan-Feb;16 Suppl 1:166-71. doi: 10.1111/j.1525-1438.2006.00504.x.
von Gruenigen VE, Huang HQ, Gil KM, Frasure HE, Armstrong DK, Wenzel LB. The association between quality of life domains and overall survival in ovarian cancer patients during adjuvant chemotherapy: a Gynecologic Oncology Group Study. Gynecol Oncol. 2012 Mar;124(3):379-82. doi: 10.1016/j.ygyno.2011.11.032. Epub 2011 Nov 23.
Walker JL, Armstrong D, Huang H, et al.: Intraperitoneal catheter outcomes on GOG 172: a Gynecologic Oncology Group study in women with optimally debulked stage III ovarian cancer. [Abstract] Int J Gynecol Cancer 14 (Suppl 1): A-062, 19, 2004.
Walker JL, Armstrong DK, Huang HQ, Fowler J, Webster K, Burger RA, Clarke-Pearson D. Intraperitoneal catheter outcomes in a phase III trial of intravenous versus intraperitoneal chemotherapy in optimal stage III ovarian and primary peritoneal cancer: a Gynecologic Oncology Group Study. Gynecol Oncol. 2006 Jan;100(1):27-32. doi: 10.1016/j.ygyno.2005.11.013.
Wenzel LB, Huang HQ, Armstrong DK, et al.: Baseline quality of life (QOL) as a predictor of tolerance to intraperitoneal (IP) chemotherapy for advanced epithelial ovarian cancer (EOC): a Gynecologic Oncology Group (GOG) study. [Abstract] J Clin Oncol 24 (Suppl 18): A-5007, 257s, 2006.
Wenzel LB, Huang HQ, Armstrong DK, Walker JL, Cella D; Gynecologic Oncology Group. Health-related quality of life during and after intraperitoneal versus intravenous chemotherapy for optimally debulked ovarian cancer: a Gynecologic Oncology Group Study. J Clin Oncol. 2007 Feb 1;25(4):437-43. doi: 10.1200/JCO.2006.07.3494.
Wenzel L, Huang HQ, Cella D, Walker JL, Armstrong DK; Gynecologic Oncology Group. Validation of FACT/GOG-AD subscale for ovarian cancer-related abdominal discomfort: a Gynecologic Oncology Group study. Gynecol Oncol. 2008 Jul;110(1):60-4. doi: 10.1016/j.ygyno.2008.02.011. Epub 2008 Apr 21.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mars 1998

Achèvement primaire (Réel)

1 janvier 2006

Dates d'inscription aux études

Première soumission

1 novembre 1999

Première soumission répondant aux critères de contrôle qualité

20 mai 2004

Première publication (Estimation)

21 mai 2004

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

27 mai 2013

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 mai 2013

Dernière vérification

1 août 2012

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

CDR0000066273
GOG-0172

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .