French Observatory of Rare Malignant Tumors of the Ovary

Ovarian Tumors Clinical Trial

Official title:

Observatoire Francophone Des Tumeurs Malignes Rares de l'Ovaire : Protocole de Prise en Charge Chez l'Adulte (Tumeurs Germinales et Des Cordons Sexuels)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304043
• Other study ID #: TMRO
• Status: Completed
• Phase: N/A
• First received: September 9, 2005
• Last updated: April 19, 2012
• Start date: January 2002
• Est. completion date: June 2011

Study information

• Verified date: April 2012
• Source: ARCAGY/ GINECO GROUP
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

To take charge of the treatment in rare adult ovarian tumors with an homogenous manner (germinal and sexual cords tumors), at different stages of the disease.

Description:

• to establish prognosis factors for the disease

• to proceed in a centralised examination of histologic laminas

• to reach in the long-term and homogenous follow-up of the patients

• to follow-up the long-term toxicities of the treatments given

• to analyse and follow-up the later fertility of the patients

• to evaluate the interest of setting a multi-disciplinary discussion forum on the Web

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age > 18 years old

• germinal or sexual cords ovary tumors histologically proven

• first line or relapse treatment

• written informed consent

Exclusion Criteria:

• mental ineptitude to understand and follow the study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ovarian Neoplasms
• Ovarian Tumors

Intervention

Drug:
• chemotherapies protocols
Cisplatine 20 mg/m² IV Etoposide 100 mg/m² IV Bléomycine 30 mg IV

Locations

Country	Name	City	State
France	Oncologie, Hôtel-Dieu, 1 place du parvis Notre-Dame	Paris

Sponsors (1)

Lead Sponsor	Collaborator
ARCAGY/ GINECO GROUP

Country where clinical trial is conducted

France, 

External Links

•   information for patients, discussion forum about "difficult" cases, therapeutic strategy for patients presenting rare ovarian tumor