Ovarian Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

580

Study ID:

NCT04575935

Recruitment Status:

Recruiting

Sponsor:

M.D. Anderson Cancer Center

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There is 1 Location for this study

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M D Anderson Cancer Center
Houston Texas, 77030, United States More Info
Jose A. Rauh-Hain
Contact
713-794-1759
[email protected]
Jose A. Rauh-Hain
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

580

Study ID:

NCT04575935

Recruitment Status:

Recruiting

Sponsor:


M.D. Anderson Cancer Center

How clear is this clinincal trial information?

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