Second Look Laparoscopy for Ovarian Cancer

Recruiting at 8 trial locations

Overseen By Rachel Grisham, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Inability to swallow, Impaired absorption

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the benefits of second look laparoscopy (SLL), a follow-up surgery, for individuals with advanced ovarian cancer after chemotherapy. Researchers aim to determine if this procedure identifies small amounts of leftover cancer cells and to compare outcomes between those with and without these cells. The study also assesses the safety and practicality of this follow-up surgery for patients. Ideal candidates have undergone or will undergo surgery for advanced ovarian cancer and have completed initial chemotherapy. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on a treatment that would prevent the second look laparoscopy surgery, you might need to adjust your medications.

What prior data suggests that Second Look Laparoscopy is safe for people with advanced ovarian cancer?

Research has shown that second look laparoscopy (SLL) is safe for individuals with advanced ovarian cancer who have completed their first round of chemotherapy. Studies confirm that SLL is both safe and practical for these patients. This procedure uses a small camera inserted into the body to check for any remaining cancer cells after treatment.

No major safety concerns have been reported for SLL, making it a well-tolerated procedure. It is as safe as other common procedures like laparotomy, which is more invasive. Research indicates that individuals generally recover well after an SLL, with no unexpected side effects.

For those considering a trial involving SLL, current evidence suggests it is a safe option for assessing the status of ovarian cancer after initial treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Second Look Laparoscopy (SLL) for ovarian cancer because it offers a proactive approach to detecting residual cancer cells that might be missed with standard observation or maintenance therapy. Unlike the current standard of care, which typically involves regular monitoring and chemotherapy, SLL involves a surgical procedure that allows doctors to directly visualize and assess the abdominal cavity. This method could lead to earlier intervention and potentially better outcomes by identifying and addressing cancer recurrence sooner.

What evidence suggests that Second Look Laparoscopy is effective for advanced ovarian cancer?

Research has shown that a second look laparoscopy (SLL), which participants in this trial will undergo, can benefit patients with advanced ovarian cancer. Studies indicate that patients with a negative SLL, meaning no visible cancer is found, tend to have better long-term outcomes. Specifically, those with negative results have higher chances of being disease-free for 3 and 5 years, at 76.3% and 58.5%, compared to 55.7% and 16% for those with positive results (some remaining cancer). Additionally, SLL benefits patients whose cancer responds to certain chemotherapy drugs, known as a platinum-sensitive relapse. Overall, SLL helps doctors better understand a patient's condition after initial treatment and guide future care decisions. ^{2 3 6 7 8}

Who Is on the Research Team?

Rachel Grisham, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with advanced ovarian cancer who have finished their first round of chemotherapy. It aims to see if a procedure called Second Look Laparoscopy (SLL) can help determine the presence of minimal residual disease—tiny amounts of cancer cells left after treatment.

Inclusion Criteria

I am 18 or older and was assigned female at birth.

I have advanced ovarian cancer and am undergoing or planning to undergo surgery to remove as much of it as possible.

I have another cancer type, but it won't affect this trial's treatment.

Exclusion Criteria

I cannot take pills by mouth or have issues absorbing food due to stomach surgery.

I am undergoing treatment that allows for SLL surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Participants complete their first course of chemotherapy

Varies

Second Look Laparoscopy (SLL)

Participants undergo a second look laparoscopy to assess minimal residual disease (MRD) status

1 day

1 visit (in-person)

Follow-up

Participants are monitored for health outcomes and safety after SLL

up to 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Second Look Laparoscopy

Trial Overview The study tests the effectiveness and safety of Second Look Laparoscopy (SLL) in detecting minimal residual disease in patients post-chemotherapy. Researchers will compare health outcomes between those with MRD and without MRD at the time of SLL.

How Is the Trial Designed?

Group I: Second Look Laparoscopy (SLL) Experimental Treatment 1 Intervention

Patients will be treated with standard of care observation or maintenance therapy as per investigator decision.The only investigational intervention performed through this study is the SLL.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

In a study of 171 patients with epithelial ovarian cancer, those who underwent a negative surgical second look (SSL) had better disease-free survival (DFS) and overall survival (OS) compared to those who were simply observed, but the recurrence rate after negative SSL was still high at 62.8%.

The study suggests that while SSL can identify disease presence, it does not significantly improve survival outcomes, especially since secondary treatments after positive SSL did not show clear benefits, indicating that routine SSL may be unnecessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical second-look in epithelial ovarian cancer: high recurrence rate after negative results and lack of survival benefit limits its role in standard management. Taşkın, S., Güngör, M., Taşkın, EA., et al.[2021]

A second look laparotomy in patients with epithelial ovarian carcinoma showed a significant prognostic value, with a 5-year survival rate of 63% for those with no residual tumor compared to only 4% for those with residual tumor.

However, the study found that performing a tumoral exenteration during the second look did not improve survival rates, as it only resulted in a 5-year survival of 7%, highlighting the importance of effective initial surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of second look laparotomy in the management of epithelial ovarian tumors. 88 interventions performed at the Dijon CAC between 1979 and 1990]. Ollivier, L., Fraisse, J., Barillot, I., et al.[2010]

In a study of 54 patients with comprehensively staged stage I epithelial ovarian cancer, only 5.5% had positive findings during second-look laparotomy, indicating that this procedure may have limited utility in detecting residual disease after initial treatment.

Patients with stage I, grade 3 tumors faced a high risk of recurrence (approximately 50%) even after a negative second-look laparotomy, highlighting the importance of tumor grade in predicting long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second-look laparotomy in stage I ovarian cancer following comprehensive surgical staging. Rubin, SC., Jones, WB., Curtin, JP., et al.[2009]

In a study of 56 women with advanced ovarian cancer, second-look laparoscopy was able to identify residual malignancy in 5 patients, allowing for a less invasive approach compared to traditional second-look laparotomy.

The findings suggest that a positive result from second-look laparoscopy can replace the need for laparotomy, while a negative result still necessitates laparotomy, indicating that laparoscopy can effectively minimize the risks associated with more invasive surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The place of second-look laparoscopy in monitoring treatment of advanced malignant ovarian neoplasms]. Skret, A., Kluza, R., Fabisiak, W.[2017]

Laparoscopic second-look operations in ovarian cancer patients are safe and accurate, with a low overall complication rate of 2.7% and a conversion to laparotomy rate of only 12%.

Out of 150 patients studied, 54% had positive second-look evaluations, indicating that this method can effectively assess disease status after initial treatment, similar to traditional laparotomy approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of laparoscopy in second-look evaluations for ovarian cancer. Husain, A., Chi, DS., Prasad, M., et al.[2022]

In a study of 171 patients with advanced ovarian cancer, 56.2% achieved a complete pathologic response (CPR) after second-look laparotomy, indicating a significant level of treatment effectiveness.

Patients with microscopic disease (R(micro)) had significantly longer survival compared to those who experienced recurrence after negative second-look laparotomy results, likely due to earlier chemotherapy administration in the R(micro) group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis of the results and long-term follow-up of second-look laparotomy in advanced ovarian cancer. Sawicki, S., Wydra, D., Kobierski, J., et al.[2020]

Second-look laparotomy (SLL) does not show clear evidence of increasing disease-free or overall survival in ovarian cancer patients, suggesting it should only be performed in research settings until more definitive data is available.

While SLL can identify residual tumors in patients who appear to be in clinical remission, the recurrence rate after a negative SLL is about 35%, indicating that the procedure may not be necessary if no tumors are found.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second-look and second surgery: second chance or second best? Sijmons, EA., Heintz, AP.[2019]

Second-look laparotomy (SLL) can help identify patients with advanced ovarian cancer who may benefit from further treatment, especially in cases where there is no residual disease, but its effectiveness depends on patient characteristics like age and histologic grade.

Recent evidence indicates that tumor reduction during SLL can improve survival rates for certain patients, highlighting the need for ongoing clinical trials to ensure all patients have access to effective consolidation and salvage therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Second-look operation in ovarian cancer. Podratz, KC., Kinney, WK.[2010]

Laparoscopic second-look surgery for ovarian cancer showed a 100% positive predictive value for diagnosing residual tumors, indicating it is effective in confirming the presence of disease when detected.

However, the feasibility of laparoscopic second-look was limited, with only 41% of cases able to be fully examined due to severe post-operative adhesions, compared to 95% for laparotomy, highlighting potential complications and risks associated with the laparoscopic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Second-look in ovarian cancer: laparoscopy or laparotomy?]. Russo, A., Cirelli, G., Cassese, E., et al.[2006]

In a preliminary study of 33 second-look procedures for ovarian carcinoma, laparoscopy was performed in 13 cases, demonstrating a low complication rate for trained laparoscopists.

The study found that the prognosis after negative results from second-look laparoscopy is similar to that of second-look laparotomy, indicating that laparoscopy can be a safe and effective alternative for evaluating ovarian cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Technique and preliminary results in second-look laparoscopy in epithelial malignant ovarian tumors]. Canis, M., Chapron, C., Mage, G., et al.[2006]

In a study of 39 patients with advanced ovarian cancer who underwent second-look laparotomy (SLL), 41% had visible disease, and 15% had microscopic tumors, indicating that SLL can reveal residual cancer in a significant number of cases.

Despite some patients benefiting from further treatment after positive SLL findings, there was no significant difference in survival rates between those who underwent SLL and those who did not, suggesting that the routine use of SLL may not be justified outside of clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A reassessment of the role of second-look laparotomy in advanced ovarian cancer. Ho, AG., Beller, U., Speyer, JL., et al.[2017]

In a study of 178 ovarian cancer patients who underwent second look laparotomy (SLL) after initial treatment, those with a positive SLL had a significantly lower 5-year survival rate of only 20%, indicating poor prognosis.

Conversely, patients with a negative SLL had a much better 5-year survival rate of 78.3%, suggesting that a negative SLL is a strong indicator of better long-term outcomes, although the prognostic factors in this group did not significantly predict survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The correlation between prognostic factors and outcome of second look laparotomy in ovarian cancer]. Dudziak, M., Klasa-Mazurkiewicz, D., Milczek, T., et al.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3479993/

Results of Second-Look Laparotomy in Advanced Ovarian ... The 3- and 5-year disease-free survivals were, respectively, 76.3% and 58.5% in negative SLL versus 55.7% and 16% in positive SLL. The difference between the ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0029784498003342

Ten-year follow-up of ovarian cancer patients after second- ... At the close of the study, the ovarian cancer mortality after second-look laparotomy with negative findings was 42% (38 of 91 patients). Recurrence-free ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06240598/a-study-of-second-look-laparoscopy-sll-in-people-with-ovarian-cancer-who-have-completed-their-first-course-of-chemotherapy

A Study of Second Look Laparoscopy (SLL) in People With ... The researchers are doing this study to look at the health outcomes of people with advanced ovarian cancer who have a second look ...

4. international-journal-of-gynecological-cancer.com international-journal-of-gynecological-cancer.com/article/S1048-891X(25)00830-8/fulltext

The Role Of Second-Look Surgery In Recurrent Ovarian ... Conclusion Our study demonstrates a significant benefit associated with second-look surgery for ovarian cancer patients with platinum-sensitive relapse, where ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7968359/

Comparison of the survival outcomes of laparoscopy ... Laparoscopy and laparotomy appear to provide comparable overall survival and progression-free survival outcomes for patients with eEOC.

6. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-01075

Second Look Laparoscopy for Disease Evaluation in ... This clinical trial tests the safety, feasibility, and outcomes of undergoing a second look laparoscopy (SLL) for disease status evaluation after initial ...

7. e-emj.org e-emj.org/journal/view.php?doi=10.12771/emj.2019.42.2.15

Is Second Look Laparoscopy for Diagnosing Remaining ... In our study, second look laparoscopic surgery was effective for diagnosing remnant ovarian cancer when negative predictive rates were low and all imaging ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0090825898952726

Second Look for Ovarian Cancer: Laparoscopy or ... After treatment of ovarian cancer, a laparoscopic second look appears to be less reliable than one performed by laparotomy.