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Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial

Primary Purpose

Advanced Ovarian Carcinoma, Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Tumor

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Chemotherapy
Laparotomy
Minimally Invasive Surgery
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Ovarian Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Miami Miller School of Medicine-Sylvester Cancer CenterRecruiting
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterRecruiting
  • DukeRecruiting
  • Lyndon Baines Johnson GeneralRecruiting
  • M D Anderson Cancer CenterRecruiting
  • University of Wisconsin Carbone Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A (MIS, standard of care chemotherapy)

Arm B (laparotomy, standard of care chemotherapy)

Arm 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.

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.

Outcomes

Primary Outcome Measures

Disease free survival (DFS)
Kaplan Meier curves will be used to describe DFS over time. Log-rank test will be used to compare DFS between the control and experimental arms. The treatment effects will be summarized by means of a hazard ratio with its associated 95% confidence interval. Two years DFS rate will be computed with a targeted 95% confidence interval (CI).

Secondary Outcome Measures

Health related-quality of life (HR-QoL)
HR-QoL of patients will be assessed with European Organization for Research and Treatment of Cancer (EORTC Scale 1-Not at all, 2-A little bit, 3-Quite a bit, 4-Very Much)
Health related-quality of life (HR-QoL)
HR-QoL of patients will be assessed Quality of Life Questionnaire-Core 30 (QLQC30 scale 1-Not at all, 2-A little bit, 3-Quite a bit, 4-Very Much)
Health related-quality of life (HR-QoL)
HR-QoL of patients will be assessed with QLQ-Ovarian Cancer Module (OV28 Scale 1- Not at all, 2- A little bit, 3-Quite a bit, 4-Very Much).) (ovarian supplement)
Health related-quality of life (HR-QoL)
HR-QoL of patients will be assessed with Functional Assessment of Cancer Therapy-General short-form (FACT-G7 Scale 1- Not at all, 2- A little bit, 3-Quite a bit, 4-Very Much).
Optimal cytoreduction
Defined as residual tumor nodules each measuring 1 cm or less in maximum diameter.
Complete cytoreduction
Defined as no evidence of macroscopic disease.
Overall survival (OS)
Overall survival will be estimated using the Kaplan-Meier method, and will be described using the median with its 95% CI. Univariate Cox proportional hazards model (i.e., logrank test) will be used to estimate hazard ratios (HR: control arm versus investigational arm) with a 95% CI. When appropriate, multivariate Cox analyses will be performed, in which a univariate selection procedure will serve to identify eligible explanatory variables with univariate Cox (using Wald test) p-value lower than 0.10 as potential prognostic value. Follow-up will be estimated using the reverse Kaplan-Meier method, and will be described using the median with its 95% CI.
Surgical morbidity
Rates of surgical complications according to Surgical morbidity (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5.0 & Clavien Dindo classification and mortality (30-day post-operative for adverse events and up to 6 months post-operative for adverse events of interest).
Mortality
Mortality rates (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5.0 & Clavien Dindo classification and mortality (30-day post-operative for adverse events and up to 6 months post-operative for adverse events of interest).
Intraoperative injuries
Coded as yes or no and categorized as involving the bowel, veins, arteries, ureter, bladder, or other site.
Minimally invasive surgery (MIS) converted to laparotomy
Prospectively completed forms documented reasons for conversion of MIS to laparotomy.
Cost of the procedure
A cost analysis may be performed in some countries.

Full Information

First Posted
September 8, 2020
Last Updated
June 29, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04575935
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 5, 2020 (Actual)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Ovarian Carcinoma, Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Tumor, Fallopian Tube Serous Neoplasm, Fallopian Tube Transitional Cell Carcinoma, Ovarian Clear Cell Adenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Serous Adenocarcinoma, Ovarian Transitional Cell Carcinoma, Primary Peritoneal Clear Cell Adenocarcinoma, Primary Peritoneal Endometrioid Adenocarcinoma, Primary Peritoneal Serous Adenocarcinoma, Primary Peritoneal Transitional Cell Carcinoma, Stage IIIC Fallopian Tube Cancer AJCC v8, Stage IIIC Ovarian Cancer AJCC v8, Stage IIIC Primary Peritoneal Cancer AJCC v8, Stage IV Fallopian Tube Cancer AJCC v8, Stage IV Ovarian Cancer AJCC v8, Stage IV Primary Peritoneal Cancer AJCC v8, Stage IVA Fallopian Tube Cancer AJCC v8, Stage IVA Ovarian Cancer AJCC v8, Stage IVA Primary Peritoneal Cancer AJCC v8, Stage IVB Fallopian Tube Cancer AJCC v8, Stage IVB Ovarian Cancer AJCC v8, Stage IVB Primary Peritoneal Cancer AJCC v8

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
580 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A (MIS, standard of care chemotherapy)
Arm Type
Experimental
Arm 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.
Arm Title
Arm B (laparotomy, standard of care chemotherapy)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Other Intervention Name(s)
Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General
Intervention Description
Receive standard of care chemotherapy
Intervention Type
Procedure
Intervention Name(s)
Laparotomy
Intervention Description
Undergo laparotomy
Intervention Type
Procedure
Intervention Name(s)
Minimally Invasive Surgery
Other Intervention Name(s)
Minimally-Invasive Surgery
Intervention Description
Undergo MIS
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Disease free survival (DFS)
Description
Kaplan Meier curves will be used to describe DFS over time. Log-rank test will be used to compare DFS between the control and experimental arms. The treatment effects will be summarized by means of a hazard ratio with its associated 95% confidence interval. Two years DFS rate will be computed with a targeted 95% confidence interval (CI).
Time Frame
Between randomization and physical or radiographic evidence of recurrence (local/distant) or death (all causes), assessed up to 5 years
Secondary Outcome Measure Information:
Title
Health related-quality of life (HR-QoL)
Description
HR-QoL of patients will be assessed with European Organization for Research and Treatment of Cancer (EORTC Scale 1-Not at all, 2-A little bit, 3-Quite a bit, 4-Very Much)
Time Frame
Up to 1 year post surgery chemotherapy
Title
Health related-quality of life (HR-QoL)
Description
HR-QoL of patients will be assessed Quality of Life Questionnaire-Core 30 (QLQC30 scale 1-Not at all, 2-A little bit, 3-Quite a bit, 4-Very Much)
Time Frame
Up to 1 year post surgery chemotherapy
Title
Health related-quality of life (HR-QoL)
Description
HR-QoL of patients will be assessed with QLQ-Ovarian Cancer Module (OV28 Scale 1- Not at all, 2- A little bit, 3-Quite a bit, 4-Very Much).) (ovarian supplement)
Time Frame
Up to 1 year post surgery chemotherapy
Title
Health related-quality of life (HR-QoL)
Description
HR-QoL of patients will be assessed with Functional Assessment of Cancer Therapy-General short-form (FACT-G7 Scale 1- Not at all, 2- A little bit, 3-Quite a bit, 4-Very Much).
Time Frame
Up to 1 year post surgery chemotherapy
Title
Optimal cytoreduction
Description
Defined as residual tumor nodules each measuring 1 cm or less in maximum diameter.
Time Frame
At the end of surgery
Title
Complete cytoreduction
Description
Defined as no evidence of macroscopic disease.
Time Frame
At the end of surgery
Title
Overall survival (OS)
Description
Overall survival will be estimated using the Kaplan-Meier method, and will be described using the median with its 95% CI. Univariate Cox proportional hazards model (i.e., logrank test) will be used to estimate hazard ratios (HR: control arm versus investigational arm) with a 95% CI. When appropriate, multivariate Cox analyses will be performed, in which a univariate selection procedure will serve to identify eligible explanatory variables with univariate Cox (using Wald test) p-value lower than 0.10 as potential prognostic value. Follow-up will be estimated using the reverse Kaplan-Meier method, and will be described using the median with its 95% CI.
Time Frame
Between randomization and death (all causes), assessed up to 5 years
Title
Surgical morbidity
Description
Rates of surgical complications according to Surgical morbidity (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5.0 & Clavien Dindo classification and mortality (30-day post-operative for adverse events and up to 6 months post-operative for adverse events of interest).
Time Frame
Up to 6 months post surgery
Title
Mortality
Description
Mortality rates (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5.0 & Clavien Dindo classification and mortality (30-day post-operative for adverse events and up to 6 months post-operative for adverse events of interest).
Time Frame
Up to 6 months post surgery
Title
Intraoperative injuries
Description
Coded as yes or no and categorized as involving the bowel, veins, arteries, ureter, bladder, or other site.
Time Frame
During surgery
Title
Minimally invasive surgery (MIS) converted to laparotomy
Description
Prospectively completed forms documented reasons for conversion of MIS to laparotomy.
Time Frame
During surgery
Title
Cost of the procedure
Description
A cost analysis may be performed in some countries.
Time Frame
Up to 6 months post surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jose A. Rauh-Hain
Phone
713-794-1759
Email
jarauh@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose A Rauh-Hain
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Miller School of Medicine-Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdulrahman Sinno, MD
Email
ak.sinno@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Abdulrahman Sinno, MD
Facility Name
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Melamed, MD
Phone
212-342-6895
Email
am5195@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Alexander Melamed, MD
Facility Name
Duke
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leah McNally, MD
Phone
919-780-7070
Email
Leah.McNally018@duke.edu
First Name & Middle Initial & Last Name & Degree
Leah McNally, MD
Facility Name
Lyndon Baines Johnson General
City
Houston
State/Province
Texas
ZIP/Postal Code
77026
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Rauh-Hain, MD
Phone
713-794-1759
Email
jarauh@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Jose Rauh-Hain, MD
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose A. Rauh-Hain
Phone
713-794-1759
Email
jarauh@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Jose A. Rauh-Hain
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Barroilhet, MD
Phone
608-263-1210
Email
barroilhet@wisc.edu
First Name & Middle Initial & Last Name & Degree
Lisa Barroilhet, MD

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

Learn more about this trial

Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial

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