Role of Surgery in Advanced Ovarian Cancer

NCT03980028 | Completed

• 1 other identifier: 18 HLGENF 01
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

To demonstrate that ultra-radical surgery with multiple visceral resections and high tumor burden prior to surgery independently reduces the survival of patients with advanced ovarian cancer treated with complete cytoreductive surgery.

Conditions

Ovarian Cancer

Keywords

surgery; cancer; ovarian; advanced

Outcome Measures

Primary Outcomes (2)

• Patient survival

  patient survival after surgery (patient record)

  4 years

• Evaluation of the tumor burden

  Measurement of tumor size before surgery (patient record)

  1 day

Secondary Outcomes (3)

• Evaluation of the extension of carcinomatosis

  1 day

• Evaluation of the invasion of celiac lymph nodes

  1 day

• Combination of surgical procedures

  1 day

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: ovarian cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients diagnosed with advanced epithelial ovarian cancer (IIIC-IVB of FIGO 2014) treated with cytoreduction surgery between 2008, January and 2015, December

You may qualify if:

• confirmed histological diagnosis of ovarian epithelial cancer
• complete cytoreduction surgery

You may not qualify if:

• women under 18 years or presence of residual tumor \>2.5mm after surgery or lack of data on performed surgical procedures or surgery performed before 2008, January or after 2015, Decembrer.

Sponsors & Collaborators

• Institut Claudius Regaud: lead
• Institut Bergonié: collaborator
• Institut Paoli-Calmettes: collaborator
• Institut du Cancer de Montpellier - Val d'Aurelle: collaborator
• Hospital Universitario La Paz: collaborator
• Hospital Vall d'Hebron: collaborator

Study Sites (1)

Institut Claudius Regaud - IUCT-Oncopole

Toulouse, Occitanie, 31059, France

Location

Related Publications (8)

• Bristow RE, Chi DS. Platinum-based neoadjuvant chemotherapy and interval surgical cytoreduction for advanced ovarian cancer: a meta-analysis. Gynecol Oncol. 2006 Dec;103(3):1070-6. doi: 10.1016/j.ygyno.2006.06.025. Epub 2006 Jul 27.

  PMID: 16875720 RESULT

• Vergote I, Trope CG, Amant F, Kristensen GB, Ehlen T, Johnson N, Verheijen RH, van der Burg ME, Lacave AJ, Panici PB, Kenter GG, Casado A, Mendiola C, Coens C, Verleye L, Stuart GC, Pecorelli S, Reed NS; European Organization for Research and Treatment of Cancer-Gynaecological Cancer Group; NCIC Clinical Trials Group. Neoadjuvant chemotherapy or primary surgery in stage IIIC or IV ovarian cancer. N Engl J Med. 2010 Sep 2;363(10):943-53. doi: 10.1056/NEJMoa0908806.

  PMID: 20818904 RESULT

• du Bois A, Reuss A, Pujade-Lauraine E, Harter P, Ray-Coquard I, Pfisterer J. Role of surgical outcome as prognostic factor in advanced epithelial ovarian cancer: a combined exploratory analysis of 3 prospectively randomized phase 3 multicenter trials: by the Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom (AGO-OVAR) and the Groupe d'Investigateurs Nationaux Pour les Etudes des Cancers de l'Ovaire (GINECO). Cancer. 2009 Mar 15;115(6):1234-44. doi: 10.1002/cncr.24149.

  PMID: 19189349 RESULT

• Eisenkop SM, Spirtos NM, Friedman RL, Lin WC, Pisani AL, Perticucci S. Relative influences of tumor volume before surgery and the cytoreductive outcome on survival for patients with advanced ovarian cancer: a prospective study. Gynecol Oncol. 2003 Aug;90(2):390-6. doi: 10.1016/s0090-8258(03)00278-6.

  PMID: 12893206 RESULT

• Chi DS, Franklin CC, Levine DA, Akselrod F, Sabbatini P, Jarnagin WR, DeMatteo R, Poynor EA, Abu-Rustum NR, Barakat RR. Improved optimal cytoreduction rates for stages IIIC and IV epithelial ovarian, fallopian tube, and primary peritoneal cancer: a change in surgical approach. Gynecol Oncol. 2004 Sep;94(3):650-4. doi: 10.1016/j.ygyno.2004.01.029.

  PMID: 15350354 RESULT

• Chi DS, Eisenhauer EL, Zivanovic O, Sonoda Y, Abu-Rustum NR, Levine DA, Guile MW, Bristow RE, Aghajanian C, Barakat RR. Improved progression-free and overall survival in advanced ovarian cancer as a result of a change in surgical paradigm. Gynecol Oncol. 2009 Jul;114(1):26-31. doi: 10.1016/j.ygyno.2009.03.018. Epub 2009 Apr 23.

  PMID: 19395008 RESULT

• Chi DS, Zivanovic O, Levinson KL, Kolev V, Huh J, Dottino J, Gardner GJ, Leitao MM Jr, Levine DA, Sonoda Y, Abu-Rustum NR, Brown CL, Barakat RR. The incidence of major complications after the performance of extensive upper abdominal surgical procedures during primary cytoreduction of advanced ovarian, tubal, and peritoneal carcinomas. Gynecol Oncol. 2010 Oct;119(1):38-42. doi: 10.1016/j.ygyno.2010.05.031. Epub 2010 Jul 6.

  PMID: 20609464 RESULT

• Schulman-Green D, Ercolano E, Dowd M, Schwartz P, McCorkle R. Quality of life among women after surgery for ovarian cancer. Palliat Support Care. 2008 Sep;6(3):239-47. doi: 10.1017/S1478951508000497.

  PMID: 18662417 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 10, 2019
• Study Start: January 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: June 1, 2019
• Last Updated: June 10, 2019

Record last verified: 2019-06

Locations

FR (1)