Stage III and IV Ovarian Cancer
Conditions
Brief summary
neoadjuvant chemotherapy in stage III and IV ovarian cancer is given in 3-4 cycles with patients who R0 surgical resection is less likely to occur, in this study will assess total neoadjuvant chemotherapy 6 cycles then interval debulking surgery (experimental arm) versus 4 cycles then interval debulking surgery (control arm) in patients who achieve partial response or stationary disease by imaging after 3- 4 cycles of neoadjuvant chemotherapy, investigators'' primary end points will be event free survival, safety and tolerability and time to relapse, our secondary end points will be overall survival and surgical morbidity and mortality
Interventions
Neoadjuvant chemotherapy (Paclitaxel and Carboplatin) will be given in complete six cycles
Sponsors
Assiut University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. \> 18 years of age 2. Recently diagnosed with stage III and IV OC 3. Patients eligible for Platinum-based CTH 4. Patients have PR or SD after 3-4 cycles of NACT
Exclusion criteria
1. Relapsed ovarian cancer 2. patients ineligible for Platinum-based CTH 3. Patient not candidate for IDS 4. stage I, II OC 5. Patients progressed after 3 cycles 7-Patients do not tolerate CTH
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| event free survival | it will be measured after 24 months, 36 months and 50 months from neoadjuvant chemotherapy and surgery | the length of time after primary treatment for a cancer ends that the patient remains free of certain complications or events that the treatment was intended to prevent or delay. it will be measured after 24 months, 36 months and 50 months from neoadjuvant chemotherapy and surgery |
Contacts
Primary ContactAhmed Gamal
Outcome results
None listed