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

NCT04575935 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 2020-0165NCI-2020-04165
• Study Type: interventional
• Target: 580
• Locations: 5 countries
• Sites: 19

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.

Conditions

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 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; Advanced Ovarian Carcinoma; Primary Peritoneal Clear Cell Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• 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).

  Between randomization and physical or radiographic evidence of recurrence (local/distant) or death (all causes), assessed up to 5 years

Secondary Outcomes (12)

• Health related-quality of life (HR-QoL)

  Up to 1 year post surgery chemotherapy

• Health related-quality of life (HR-QoL)

  Up to 1 year post surgery chemotherapy

• Health related-quality of life (HR-QoL)

  Up to 1 year post surgery chemotherapy

• Health related-quality of life (HR-QoL)

  Up to 1 year post surgery chemotherapy

• Optimal cytoreduction

  At the end of surgery

Study Arms (2)

Arm A (MIS, standard of care chemotherapy)

EXPERIMENTAL

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.

Drug: Chemotherapy; Procedure: Minimally Invasive Surgery; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm B (laparotomy, standard of care chemotherapy)

ACTIVE COMPARATOR

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.

Drug: Chemotherapy; Procedure: Laparotomy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Chemotherapy DRUG

Receive standard of care chemotherapy

Also known as: Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General

Arm A (MIS, standard of care chemotherapy); Arm B (laparotomy, standard of care chemotherapy)

Laparotomy PROCEDURE

Undergo laparotomy

Arm B (laparotomy, standard of care chemotherapy)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm A (MIS, standard of care chemotherapy); Arm B (laparotomy, standard of care chemotherapy)

Questionnaire Administration OTHER

Ancillary studies

Arm A (MIS, standard of care chemotherapy); Arm B (laparotomy, standard of care chemotherapy)

Minimally Invasive Surgery PROCEDURE

Undergo MIS

Also known as: Minimally-Invasive Surgery

Arm A (MIS, standard of care chemotherapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• M.D. Anderson Cancer Center: lead

Study Sites (19)

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States

RECRUITING

Cleveland Clinic Foundation - Florida

Weston, Florida, 33331, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

NYU Langone Health

Mineola, New York, 11501, United States

RECRUITING

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

Duke

Durham, North Carolina, 27710, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

St. Luke's University Health Network

Bethlehem, Pennsylvania, 18015, United States

RECRUITING

Lyndon Baines Johnson General

Houston, Texas, 77026, United States

RECRUITING

Houston Methodist

Houston, Texas, 77030, United States

RECRUITING

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

ACTIVE NOT RECRUITING

Arthur J.E. Child Comprehensive Cancer Centre - Calgary

Calgary, Canada

RECRUITING

University Health Network - Princess Margaret Cancer Centre

Toronto, Canada

RECRUITING

Sant'Orsola Hospital di Bologna

Bologna, 40138, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

Instituto Nacional de Cancerología (Mexico)

Tlalpan, Mexico

RECRUITING

Amsterdam UMC - Locatie AMC | H5Zuid 154

Amsterdam, Netherlands

RECRUITING

Related Publications (1)

• Rauh-Hain JA, Melamed A, Pareja R, May T, Sinno A, McNally L, Horowitz NS, De Iaco P, Michener CM, Van Lonkhuijzen L, Iniesta MD, Yuan Y, Ramirez PT, Fagotti A. Laparoscopic Cytoreduction After Neoadjuvant Chemotherapy in High-Grade Epithelial Ovarian Cancer: A LANCE Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2446325. doi: 10.1001/jamanetworkopen.2024.46325.

  PMID: 39570589 DERIVED

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

Drug Therapy; Laparotomy; Minimally Invasive Surgical Procedures

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Officials

• Jose A Rauh-Hain

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose A. Rauh-Hain, MD, MPH

CONTACT

713-794-1759; jarauh@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: October 5, 2020
• Study Start: August 5, 2020
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 5, 2026

Record last verified: 2026-03

Locations

US (13); NL (1); IT (2); CA (2); ME (1)