Brief Title
Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial
Official Title
Laparoscopic Cytoreduction After Neoadjuvant Chemotherapy
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 incision(s) 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 and/or 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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Disease free survival (DFS)
Secondary Outcome
Health related-quality of life (HR-QoL)
Condition
Advanced Ovarian Carcinoma
Intervention
Chemotherapy
Study Arms / Comparison Groups
Arm A (MIS, standard of care chemotherapy)
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
580
Start Date
August 5, 2020
Completion Date
May 15, 2023
Primary Completion Date
May 15, 2023
Eligibility Criteria
Inclusion Criteria:
- Stage IIIC or IV, high-grade (serous, endometrioid, clear-cell, transitional
carcinomas), invasive epithelial ovarian carcinoma, primary peritoneal carcinoma, or
fallopian-tube carcinoma or pathology consistent with high-grade Mullerian carcinoma
- Complete or partial response to 3 or 4 cycles of NACT (clinical response will be
assessed by clinical radiologist at each site, with Response Evaluation Criteria in
Solid Tumors [RECIST] 1.1 guidance provided)
- Patients that received only 3 cycles of NACT must have completed their regimen within
9 weeks. Patients that received 4 cycles of NACT must have completed their regimen
within 12 weeks
- Normalization of CA-125 according to individual participating center reference range
(Note: Among patients with a normal CA-125 at initiation of therapy, the CA-125 cannot
exceed 35 U/mL at the completion of 3 or 4 cycles if NACT prior to interval debulking
surgery)
- Time frame of < 6 weeks from the last cycle of NACT to interval debulking surgery
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Signed informed consent and ability to comply with follow-up
- Negative pregnancy test by blood or urine (within 14 days prior to surgery)
Exclusion Criteria:
- Evidence of tumor not amenable to minimally invasive resection on pre-operative
imaging (computed tomography [CT], positron emission tomography [PET]-CT, or magnetic
resonance imaging [MRI]) including but not limited to the following findings
- Failure of improvement of ascites during NACT (trace ascites is allowed)
- Small bowel or gastric tumor involvement
- Colon or rectal tumor involvement
- Diaphragmatic tumor involvement
- Splenic or hepatic surface or parenchymal tumor involvement
- Mesenteric tumor involvement
- Tumor infiltration of the lesser peritoneal sac
- History of other malignancies in the previous five years, except basal cell carcinoma
of the skin
- History of psychological, familial, sociological or geographical condition potentially
preventing compliance with the study protocol and follow-up schedule
- Inability to tolerate prolonged Trendelenburg position or pneumoperitoneum as deemed
by participating institution's clinicians
- Any other contraindication to MIS as assessed by the clinician
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jose A Rauh-Hain, 713-794-1759, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04575935
Organization ID
2020-0165
Secondary IDs
NCI-2020-04165
Responsible Party
Sponsor
Study Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Jose A Rauh-Hain, Principal Investigator, M.D. Anderson Cancer Center
Verification Date
March 2023