- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04575935
Minimally Invasive Surgery After Neoadjuvant Chemotherapy for the Treatment of Stage IIIC-IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer, LANCE Trial
Laparoscopic Cytoreduction After Neoadjuvant Chemotherapy
Study Overview
Status
Conditions
- Ovarian Endometrioid Adenocarcinoma
- Ovarian Clear Cell Adenocarcinoma
- Fallopian Tube Transitional Cell Carcinoma
- Ovarian Transitional Cell Carcinoma
- Fallopian Tube Clear Cell Adenocarcinoma
- Ovarian Serous Adenocarcinoma
- Primary Peritoneal Serous Adenocarcinoma
- Primary Peritoneal Clear Cell Adenocarcinoma
- Primary Peritoneal Transitional Cell Carcinoma
- Primary Peritoneal Endometrioid Adenocarcinoma
- 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
- Advanced Ovarian Carcinoma
- Fallopian Tube Endometrioid Tumor
- Fallopian Tube Serous Neoplasm
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 Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Jose A. Rauh-Hain
- Phone Number: 713-794-1759
- Email: jarauh@mdanderson.org
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- Recruiting
- University of Miami Miller School of Medicine-Sylvester Cancer Center
-
Contact:
- Abdulrahman Sinno, MD
- Email: ak.sinno@med.miami.edu
-
Principal Investigator:
- Abdulrahman Sinno, MD
-
-
New York
-
New York, New York, United States, 10032
- Recruiting
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
-
Contact:
- Alexander Melamed, MD
- Phone Number: 212-342-6895
- Email: am5195@cumc.columbia.edu
-
Principal Investigator:
- Alexander Melamed, MD
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Recruiting
- Duke
-
Contact:
- Leah McNally, MD
- Phone Number: 919-780-7070
- Email: Leah.McNally018@duke.edu
-
Principal Investigator:
- Leah McNally, MD
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- M D Anderson Cancer Center
-
Contact:
- Jose A. Rauh-Hain
- Phone Number: 713-794-1759
- Email: jarauh@mdanderson.org
-
Principal Investigator:
- Jose A. Rauh-Hain
-
Houston, Texas, United States, 77026
- Recruiting
- Lyndon Baines Johnson General
-
Contact:
- Jose Rauh-Hain, MD
- Phone Number: 713-794-1759
- Email: jarauh@mdanderson.org
-
Principal Investigator:
- Jose Rauh-Hain, MD
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- Recruiting
- University of Wisconsin Carbone Cancer Center
-
Principal Investigator:
- Lisa Barroilhet, MD
-
Contact:
- Lisa Barroilhet, MD
- Phone Number: 608-263-1210
- Email: barroilhet@wisc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18 years old
- 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.
- Patient is considered by treating physician to be a surgical candidate after completion of 3 to 4 cycles of platinum-based chemotherapy, or an investigational neoadjuvant regimen given according to protocol, with complete radiologic resolution of any disease outside the abdominal cavity. Pleural effusions are acceptable per the local PI's discretion.
- 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 NACT prior to interval debulking surgery.) or has a CA-125 value ≤500 and is scheduled to undergo a diagnostic laparoscopy prior to debulking surgery. a. For patients undergoing diagnostic laparoscopy, surgeon considers that optimal debulking is feasible either by MIS or laparotomy.
- Timeframe of < 6 weeks (42 days) from the last cycle of NACT to interval debulking surgery. Overall timeframe may be extended per MD Anderson PI discretion.
- 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)
- Disease free of other active malignancies in the previous five years, except basal and squamous cell carcinomas of the skin
Exclusion Criteria:
- Evidence of tumor not amenable to minimally invasive resection on pre-operative imaging (CT, PET-CT, or MRI) including but not limited to the following findings that may preclude minimally invasive resection per surgeon's assessment. • 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 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A (MIS, standard of care chemotherapy)
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.
|
Ancillary studies
Other Names:
Ancillary studies
Receive standard of care chemotherapy
Other Names:
Undergo MIS
Other Names:
|
Active Comparator: Arm B (laparotomy, 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.
|
Ancillary studies
Other Names:
Ancillary studies
Undergo laparotomy
Receive standard of care chemotherapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease free survival (DFS)
Time Frame: Between randomization and physical or radiographic evidence of recurrence (local/distant) or death (all causes), assessed up to 5 years
|
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).
|
Between randomization and physical or radiographic evidence of recurrence (local/distant) or death (all causes), assessed up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health related-quality of life (HR-QoL)
Time Frame: Up to 1 year post surgery chemotherapy
|
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)
|
Up to 1 year post surgery chemotherapy
|
Health related-quality of life (HR-QoL)
Time Frame: Up to 1 year post surgery chemotherapy
|
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)
|
Up to 1 year post surgery chemotherapy
|
Health related-quality of life (HR-QoL)
Time Frame: Up to 1 year post surgery chemotherapy
|
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)
|
Up to 1 year post surgery chemotherapy
|
Health related-quality of life (HR-QoL)
Time Frame: Up to 1 year post surgery chemotherapy
|
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).
|
Up to 1 year post surgery chemotherapy
|
Optimal cytoreduction
Time Frame: At the end of surgery
|
Defined as residual tumor nodules each measuring 1 cm or less in maximum diameter.
|
At the end of surgery
|
Complete cytoreduction
Time Frame: At the end of surgery
|
Defined as no evidence of macroscopic disease.
|
At the end of surgery
|
Overall survival (OS)
Time Frame: Between randomization and death (all causes), assessed up to 5 years
|
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.
|
Between randomization and death (all causes), assessed up to 5 years
|
Surgical morbidity
Time Frame: Up to 6 months post surgery
|
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).
|
Up to 6 months post surgery
|
Mortality
Time Frame: Up to 6 months post surgery
|
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).
|
Up to 6 months post surgery
|
Intraoperative injuries
Time Frame: During surgery
|
Coded as yes or no and categorized as involving the bowel, veins, arteries, ureter, bladder, or other site.
|
During surgery
|
Minimally invasive surgery (MIS) converted to laparotomy
Time Frame: During surgery
|
Prospectively completed forms documented reasons for conversion of MIS to laparotomy.
|
During surgery
|
Cost of the procedure
Time Frame: Up to 6 months post surgery
|
A cost analysis may be performed in some countries.
|
Up to 6 months post surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jose A Rauh-Hain, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Peritoneal Diseases
- Uterine Neoplasms
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Fallopian Tube Diseases
- Abdominal Neoplasms
- Cystadenocarcinoma
- Endometrial Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Carcinoma
- Adenocarcinoma
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Peritoneal Neoplasms
- Carcinoma, Ovarian Epithelial
- Cystadenocarcinoma, Serous
- Carcinoma, Endometrioid
- Adenocarcinoma, Clear Cell
- Carcinoma, Transitional Cell
- Neoplasms, Cystic, Mucinous, and Serous
Other Study ID Numbers
- 2020-0165 (Other Identifier: M D Anderson Cancer Center)
- NCI-2020-04165 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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