Ignite Creation Date:
2024-05-06 @ 3:16 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04575935
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2020-09-08
Brief Title:
Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian Primary Peritoneal or Fallopian Tube Cancer LANCE Trial
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Laparoscopic Cytoreduction After Neoadjuvant Chemotherapy
Status:
RECRUITING
Status Verified Date:
2024-05
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:
This phase III trial compares minimally invasive surgery MIS to laparotomy in treating patients with stage IIIC-IV ovarian primary peritoneal or fallopian tube cancer who are receiving chemotherapy before and after surgery neoadjuvant chemotherapy MIS is a surgical procedure that uses small incisions and is intended to produce minimal blood loss and pain for the patient Laparotomy is a surgical procedure which allows the doctors to remove some or all of the tumor and check if the disease has spread to other organs in the body MIS may work the same or better than standard laparotomy after chemotherapy in prolonging the return of the disease andor improving quality of life after surgery
Detailed Description:
PRIMARY OBJECTIVE
I To examine whether MIS is non-inferior to laparotomy in terms of disease free survival DFS in women with advanced stage epithelial ovarian cancer EOC that received 3 to 4 cycles of neoadjuvant chemotherapy NACT
SECONDARY OBJECTIVES
I To determine if there are differences in health-related quality of life HR-QoL in patients undergoing MIS versus vs laparotomy as assessed with the European Organisation for Research and Treatment of Cancer EORTC Quality of Life Questionnaire-Core 30 QLQ-C30 QLQ-Ovarian Cancer Module OV28 and Functional Assessment of Cancer Therapy-General FACT-G7
II To determine if there are differences between patients undergoing MIS vs laparotomy in the rate of optimal cytoreduction defined as residual tumor nodules each measuring 1 cm or less in maximum diameter and complete cytoreduction defined as no evidence of macroscopic disease
III To examine whether MIS is non-inferior to laparotomy in terms of overall survival OS in women with advanced stage EOC that received 3 to 4 cycles of NACT
IV To determine if there are differences between patients undergoing MIS vs laparotomy in surgical morbidity and mortality intraoperative injuries and post-operative complications
V To determine the rates of MIS converted to laparotomy and the reasons
VI To determine if there are any difference in costs and cost-effectiveness between patients undergoing MIS vs laparotomy
OUTLINE Patients are randomized to 1 of 2 arms
ARM A Patients undergo MIS within 6 weeks after last cycle of standard of care neoadjuvant chemotherapy If during MIS the surgeon thinks complete gross resection can only be accomplished by performing an open procedure patients may undergo laparotomy instead Within 6 weeks after surgery patients receive standard of care chemotherapy
ARM B Patients undergo laparotomy within 6 weeks after last cycle of standard of care neoadjuvant chemotherapy Within 6 weeks after surgery patients receive standard of care chemotherapy
After completion of study patients are followed up within 6 weeks of completing post-surgery chemotherapy then every 3 months for the first 2 years and then every 6 months for 3 years
I To examine whether MIS is non-inferior to laparotomy in terms of disease free survival DFS in women with advanced stage epithelial ovarian cancer EOC that received 3 to 4 cycles of neoadjuvant chemotherapy NACT
SECONDARY OBJECTIVES
I To determine if there are differences in health-related quality of life HR-QoL in patients undergoing MIS versus vs laparotomy as assessed with the European Organisation for Research and Treatment of Cancer EORTC Quality of Life Questionnaire-Core 30 QLQ-C30 QLQ-Ovarian Cancer Module OV28 and Functional Assessment of Cancer Therapy-General FACT-G7
II To determine if there are differences between patients undergoing MIS vs laparotomy in the rate of optimal cytoreduction defined as residual tumor nodules each measuring 1 cm or less in maximum diameter and complete cytoreduction defined as no evidence of macroscopic disease
III To examine whether MIS is non-inferior to laparotomy in terms of overall survival OS in women with advanced stage EOC that received 3 to 4 cycles of NACT
IV To determine if there are differences between patients undergoing MIS vs laparotomy in surgical morbidity and mortality intraoperative injuries and post-operative complications
V To determine the rates of MIS converted to laparotomy and the reasons
VI To determine if there are any difference in costs and cost-effectiveness between patients undergoing MIS vs laparotomy
OUTLINE Patients are randomized to 1 of 2 arms
ARM A Patients undergo MIS within 6 weeks after last cycle of standard of care neoadjuvant chemotherapy If during MIS the surgeon thinks complete gross resection can only be accomplished by performing an open procedure patients may undergo laparotomy instead Within 6 weeks after surgery patients receive standard of care chemotherapy
ARM B Patients undergo laparotomy within 6 weeks after last cycle of standard of care neoadjuvant chemotherapy Within 6 weeks after surgery patients receive standard of care chemotherapy
After completion of study patients are followed up within 6 weeks of completing post-surgery chemotherapy then every 3 months for the first 2 years and then every 6 months for 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| NCI-2020-04165 | REGISTRY | None | None |
| 2020-0165 | OTHER | M D Anderson Cancer Center | None |