Evaluation of Prognostic Factors for Tubo-ovarian Cancer in France

Ovarian Cancer Clinical Trial

— Pro-TOCa  

Official title:

Evaluation of Prognostic Factors for Tubo-ovarian Cancer in France: Surgical Thresholds, Geographical Distance, Age and Therapeutic Sequence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05204342
• Other study ID #: RECHMPL21_0742
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: December 30, 2021

Study information

• Verified date: January 2022
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Evaluation of the following prognostic factors in France, based on national quotation data: volume per center, patient age, geographic distance from a clinical center, delay for chemotherapy,Upfront surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22500
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• - Diagnosic of Ovarian or Tubal Cancer C56 et C570

• +/-

• Carcinose péritonéale C786

• Tumueur maligne secondaire de la plèvre C782,

• Tumueur maligne secondaire des ganglions C770 à C779,

• Tumueur maligne secondaire du foie C787,

• Tumueur maligne secondaire du péritoine C786

Exclusion criteria:

• autres causes de :

• Carcinose péritonéale C786

• Tumueur maligne secondaire de la plèvre C782,

• Tumueur maligne secondaire des ganglions C770 à C779,

• Tumueur maligne secondaire du foie C787,

• Tumueur maligne secondaire du péritoine C786

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To study the prognostic effect of the volume of activity	To study the prognostic effect of the volume of activity per center on the risk of recurrence	at 5 years
Primary	Verify that the therapeutic sequence	Verify that the therapeutic sequence of primary surgery and secondary chemotherapy is a good prognostic factor for overall and specific survival at 5 years	at 5 years
Secondary	Verify that delay in initiation of chemotherapy beyond 4 weeks	Verify that delay in initiation of chemotherapy beyond 4 weeks after surgery is a poor prognostic element on overall and specific survival at 5 years	at 5 years
Secondary	Verify that age is a poor prognostic element	Verify that age is a poor prognostic element for overall and specific survival at 5 years	at 5 years
Secondary	Verify that geographic distance	Verify that geographic distance from a clinical center is a poor prognostic element for overall and specific survival at 5 years	at 5 years