Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003636
Status:
COMPLETED
Last Update Posted:
2015-08-05
First Post:
1999-11-01
Brief Title:
Chemotherapy Plus Surgery in Treating Patients With Stage III or Stage IV Ovarian Peritoneal or Fallopian Tube Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A Randomized Phase III Study Comparing Upfront Debulking Surgery Versus Neo-Adjuvant Chemotherapy in Patients With Stage IIIC or IV Epithelial Ovarian Carcinoma
Status:
COMPLETED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining surgery with chemotherapy may kill more tumor cells It is not yet known whether chemotherapy before surgery is more effective than chemotherapy after surgery in treating ovarian peritoneal or fallopian tube cancer
PURPOSE This randomized phase III trial is studying chemotherapy given before surgery to see how well it works compared to chemotherapy given after surgery with or without additional surgery in treating patients with stage III or stage IV ovarian cancer peritoneal cancer or fallopian tube cancer
PURPOSE This randomized phase III trial is studying chemotherapy given before surgery to see how well it works compared to chemotherapy given after surgery with or without additional surgery in treating patients with stage III or stage IV ovarian cancer peritoneal cancer or fallopian tube cancer
Detailed Description:
OBJECTIVES
Compare the overall survival and progression-free survival in patients with stage IIIC or IV ovarian epithelial peritoneal or fallopian tube carcinoma treated with neoadjuvant chemotherapy followed by interval debulking surgery versus upfront cytoreductive surgery followed by chemotherapy with or without interval debulking surgery
Compare the quality of life of patients treated with these regimens
Compare the different treatment complications in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center method of biopsy stage largest tumor size before surgery and intent to also randomize on EORTC-55012 Patients are randomized to one of two treatment arms
Arm I Patients undergo upfront maximal cytoreductive surgery followed by cisplatin or carboplatin IV every 3 weeks for 3 courses Patients with non-optimal primary debulking may undergo interval debulking surgery at the physicians discretion All patients then receive an additional 3 courses of the same regimen of chemotherapy
Arm II Patients receive chemotherapy as in arm I Patients with stable or responding disease undergo interval debulking surgery followed by an additional 3 courses of the same regimen of chemotherapy
Second-look surgery is allowed for both arms if clinically indicated
Quality of life QOL is assessed prior to treatment after the third and sixth course of chemotherapy and at 6 and 12 months after study Patients who are also randomized on EORTC-55012 follow the QOL assessment schedule for EORTC-55012 only
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 704 patients will be accrued for this study within 4 years
Compare the overall survival and progression-free survival in patients with stage IIIC or IV ovarian epithelial peritoneal or fallopian tube carcinoma treated with neoadjuvant chemotherapy followed by interval debulking surgery versus upfront cytoreductive surgery followed by chemotherapy with or without interval debulking surgery
Compare the quality of life of patients treated with these regimens
Compare the different treatment complications in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center method of biopsy stage largest tumor size before surgery and intent to also randomize on EORTC-55012 Patients are randomized to one of two treatment arms
Arm I Patients undergo upfront maximal cytoreductive surgery followed by cisplatin or carboplatin IV every 3 weeks for 3 courses Patients with non-optimal primary debulking may undergo interval debulking surgery at the physicians discretion All patients then receive an additional 3 courses of the same regimen of chemotherapy
Arm II Patients receive chemotherapy as in arm I Patients with stable or responding disease undergo interval debulking surgery followed by an additional 3 courses of the same regimen of chemotherapy
Second-look surgery is allowed for both arms if clinically indicated
Quality of life QOL is assessed prior to treatment after the third and sixth course of chemotherapy and at 6 and 12 months after study Patients who are also randomized on EORTC-55012 follow the QOL assessment schedule for EORTC-55012 only
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 704 patients will be accrued for this study within 4 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EORTC-55971 | None | None | None |