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

Trial Summary

What is the purpose of this trial?

The researchers are doing this study to look at the health outcomes of people with advanced ovarian cancer who have a second look laparoscopy (SLL) after they complete their first course of chemotherapy. The researchers will compare the health outcomes of people who have minimal residual disease (MRD-small amounts of cancer cells in the body after a person receives treatment) at the time of SLL with the health outcomes of people who do not have MRD at the time of SLL. The researchers are also doing this study to determine if SLL is safe and practical (feasible) in people with advanced ovarian cancer who have completed the first course of therapy for their disease.

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 data supports the effectiveness of the treatment Second Look Laparoscopy for ovarian cancer?

The research suggests that Second Look Laparoscopy (SLL) does not significantly improve survival rates in ovarian cancer patients, as high recurrence rates are observed even after negative results, and there is no clear survival benefit. Therefore, its role in standard management is limited and should be considered mainly in a research setting. ^{1 2 3 4 5}

Is second-look laparoscopy generally safe for humans?

Research suggests that second-look laparoscopy, when performed by trained surgeons, has a low rate of surgical complications, making it a generally safe procedure for evaluating ovarian cancer. ^{1 6 7 8 9}

How is second-look laparoscopy different from other treatments for ovarian cancer?

Second-look laparoscopy is a unique procedure used to evaluate the presence of residual cancer in patients who have already undergone initial treatment for ovarian cancer. Unlike traditional second-look laparotomy, which involves a larger surgical incision, laparoscopy is minimally invasive, using small incisions and a camera to inspect the abdominal cavity, potentially reducing recovery time and surgical complications. ^{1 8 10 11 12}

Research Team

Rachel Grisham, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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 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 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 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]

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]

References

1. Turkey 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. [2021]

2. Singapore pubmed.ncbi.nlm.nih.gov

Analysis of the results and long-term follow-up of second-look laparotomy in advanced ovarian cancer. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Second-look and second surgery: second chance or second best? [2019]

4. Poland pubmed.ncbi.nlm.nih.gov

[The correlation between prognostic factors and outcome of second look laparotomy in ovarian cancer]. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Second-look operation in ovarian cancer. [2010]

6. United States pubmed.ncbi.nlm.nih.gov

The role of laparoscopy in second-look evaluations for ovarian cancer. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A reassessment of the role of second-look laparotomy in advanced ovarian cancer. [2017]

8. France pubmed.ncbi.nlm.nih.gov

[Technique and preliminary results in second-look laparoscopy in epithelial malignant ovarian tumors]. [2006]

9. Poland pubmed.ncbi.nlm.nih.gov

[The place of second-look laparoscopy in monitoring treatment of advanced malignant ovarian neoplasms]. [2017]

10. Italy pubmed.ncbi.nlm.nih.gov

[Second-look in ovarian cancer: laparoscopy or laparotomy?]. [2006]

11. France 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]. [2010]

12. United States pubmed.ncbi.nlm.nih.gov

Second-look laparotomy in stage I ovarian cancer following comprehensive surgical staging. [2009]