Peritoneal Cavity Cancer Clinical Trial
— MISSIONOfficial title:
Minimally Invasive Interval Debulking Surgery in Ovarian Neoplasm: a Feasibility Study
Verified date | April 2016 |
Source | Catholic University of the Sacred Heart |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
Phase II multicentric study
Status | Completed |
Enrollment | 30 |
Est. completion date | February 2016 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Age >18 years, - Advanced ovarian cancer submitted to neoadjuvant chemotherapy, - Clinical or serological complete/partial response (RECIST; GCIG), - PS = 2 (ECOG), - Informed consent Exclusion Criteria: - Borderline and non-epithelial ovarian tumors, - Stable/progressive disease, - ASA 3-4, - Severe cardiopulmonary disease, - BMI > 40 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Policlinico Agostino Gemelli | Rome | |
Italy | Catholic University of Sacred Heart Rome, | Rome, | Rome |
Lead Sponsor | Collaborator |
---|---|
Catholic University of the Sacred Heart | Fagotti, Anna, M.D., Francesco Fanfani, Salvatore Gueli Alletti |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Operative complication rate | Intra- and post-operative complication rate of total laparoscopic/robotic interval debulking surgery | 30 days | Yes |
Secondary | Progression Free survival | time to recurrence | one year | Yes |
Secondary | Overall Survival | time to last follow up/death | One year | Yes |
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