Minimally Invasive Surgery vs Laparotomy After Chemotherapy for Ovarian and Related Cancers

Recruiting at 6 trial locations

Overseen By Jose A. Rauh-Hain

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: M.D. Anderson Cancer Center

Must be taking: Platinum-based chemotherapy

Disqualifiers: Other malignancies, Psychological conditions, others

Stay on Your Current Meds You can continue your current medications while participating

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

580 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor to understand how your medications might interact with the trial treatments.

What data supports the effectiveness of the treatment Minimally Invasive Surgery vs Laparotomy After Chemotherapy for Ovarian and Related Cancers?

Research shows that minimally invasive surgery (MIS) can be as effective as open laparotomy for ovarian cancer after chemotherapy, with studies indicating that MIS may offer similar safety and efficacy. Additionally, cytoreductive surgery, which aims to remove as much of the tumor as possible, has been shown to increase survival rates in ovarian cancer patients. ^{1 2 3 4 5}

Is minimally invasive surgery safe compared to open surgery after chemotherapy for ovarian cancer?

Research shows that minimally invasive surgery (like laparoscopic or robotic surgery) is generally considered safe compared to open surgery (laparotomy) for ovarian cancer after chemotherapy. However, chemotherapy can have toxic effects that may complicate later surgeries, and some patients may experience hypersensitivity reactions to chemotherapy drugs like carboplatin and paclitaxel. ^{1 6 7 8 9}

How does the treatment of minimally invasive surgery versus laparotomy after chemotherapy for ovarian cancer differ from other treatments?

This treatment is unique because it compares minimally invasive surgery (like keyhole or robotic surgery) to traditional open surgery (laparotomy) after chemotherapy for ovarian cancer, offering potentially less recovery time and fewer complications while still aiming to effectively remove cancerous tissue. ^{1 3 10 11 12}

What is the purpose of this trial?

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.

Research Team

Jose Rauh-Hain, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults over 18 with advanced ovarian, primary peritoneal, or fallopian tube cancer who've had some success with chemotherapy. They should be fit enough for surgery and have no other active cancers (except certain skin cancers). Pregnant women and those unable to undergo minimally invasive surgery due to health reasons are excluded.

Inclusion Criteria

You must have a negative pregnancy test within 14 days before the surgery.

My surgery is scheduled within 6 weeks after my last chemotherapy.

I have advanced high-grade ovarian, peritoneal, or fallopian tube cancer.

Exclusion Criteria

History of psychological, familial, sociological, or geographical condition potentially preventing compliance with the study protocol and follow-up schedule

You can't stay in a tilted position for a long time, or handle having air pumped into your abdomen, as determined by the doctors at the hospital.

My doctor has not identified any reasons I can't have minimally invasive surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Chemotherapy

Participants receive 3 to 4 cycles of neoadjuvant chemotherapy before surgery

9-12 weeks

Surgery

Participants undergo either minimally invasive surgery (MIS) or laparotomy within 6 weeks after the last cycle of neoadjuvant chemotherapy

6 weeks

Post-Surgery Chemotherapy

Participants receive standard of care chemotherapy within 6 weeks after surgery

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-ups every 3 months for the first 2 years, then every 6 months for 3 years

5 years

Treatment Details

Interventions

• Chemotherapy
• Laparotomy
• Minimally Invasive Surgery

Trial Overview The LANCE trial is comparing two surgical methods after initial chemotherapy: a less invasive approach using small cuts (MIS) versus traditional open surgery (laparotomy). The goal is to see if MIS can extend the time before the cancer returns and improve life quality post-surgery.

Participant Groups

Group I: Arm A (MIS, standard of care chemotherapy) Experimental Treatment 4 Interventions

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.

Group II: Arm B (laparotomy, standard of care chemotherapy) Active Control 4 Interventions

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.

Chemotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in United States as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in Canada as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in Japan as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in China as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Approved in Switzerland as Chemotherapy for:

• Breast cancer
• Metastatic breast cancer
• Various other cancers

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Minimally invasive surgery (MIS) for ovarian cancer after neoadjuvant chemotherapy shows significantly better progression-free survival compared to open laparotomy, with a hazard ratio of 0.73, indicating a 27% reduction in the risk of disease progression.

Patients undergoing MIS had shorter hospital stays compared to those who had open laparotomy, with a significant mean difference of -1.21 days, suggesting that MIS may offer a safer and more efficient recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Minimally Invasive Surgery Versus Open Laparotomy for Interval Debulking Surgery of Advanced Ovarian Cancer After Neoadjuvant Chemotherapy: A Systematic Review and A Meta-Analysis. Zeng, S., Yu, Y., Cui, Y., et al.[2022]

Chemotherapy, particularly with platinum agents and taxanes, along with intraperitoneal chemotherapy, has significantly improved survival rates in patients with epithelial ovarian cancer.

Optimal cytoreductive surgery, which aims to remove as much tumor as possible, correlates with increased survival, with each 10% increase in tumor removal linked to a 5.5% increase in median survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of cytoreductive/debulking surgery in ovarian cancer. Wakabayashi, MT., Lin, PS., Hakim, AA.[2019]

Radical surgery combined with chemotherapy is essential for treating early-stage ovarian cancer, but there are still uncertainties regarding the optimal timing and choice of chemotherapy.

Current clinical trials are exploring the role of new chemotherapeutic agents in both advanced ovarian cancer and as adjuvant treatments, indicating ongoing research to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical trials in patients with epithelial ovarian cancer: past, present and future. Vermorken, JB., Pecorelli, S.[2019]

In a study of 72 Mexican women with unilateral ovarian cancer, conservative surgery was found to be an effective option for preserving fertility without compromising progression-free survival compared to radical surgery, as both groups showed similar survival outcomes.

The study revealed that 87.5% of patients were alive without disease after 10 years, and among those who underwent conservative surgery, 59.1% achieved pregnancy, indicating that this approach can successfully maintain reproductive function in young women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conservative surgery for ovarian cancer and effect on fertility. Gonzalez-Lira, G., Escudero-De Los Ríos, P., Salazar-Martínez, E., et al.[2019]

Ovarian cancer is the deadliest cancer of the female reproductive system, and its symptoms are often vague, making it crucial for surgeons to consider it during exploratory surgeries.

Effective surgical intervention, including accurate documentation of disease extent and tumor reduction to less than 1.6 cm, significantly improves patient prognosis and reduces the need for further surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgery in ovarian cancer. Wijnen, JA., Rosenshein, NB.[2019]

In a study of 62 patients with ovarian, fallopian tube, or primary peritoneal cancer, BRCA mutations did not significantly increase the likelihood of hypersensitivity reactions (HSRs) to carboplatin, with 30.8% of BRCA-mutated patients experiencing reactions compared to 44.9% of BRCA wild-type patients.

However, BRCA mutations were significantly associated with a lower incidence of HSRs to paclitaxel, where only 7.7% of BRCA-mutated patients had reactions compared to 53.1% of BRCA wild-type patients, indicating a potential protective effect of BRCA mutations against paclitaxel-related hypersensitivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of Hypersensitivity Reactions to Carboplatin or Paclitaxel in Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer With or Without BRCA1 or BRCA2 Mutations. Garcia, A., Frahm, C., Jeter, JM., et al.[2023]

A study analyzing 60 cases of ovarian cancer revealed that while anti-mitotic chemotherapy has improved in efficiency, it also leads to increased toxicity.

The toxicity from chemotherapy complicates subsequent surgical operations, highlighting the need for careful management of treatment side effects in ovarian cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preoperative chemotherapy of ovarian cancer in anesthesia and resuscitation]. Ranchère, JY., Lombard, R., Lupo, C.[2016]

In a study of 27 patients with Stage III ovarian cancer, those with microscopic disease at a second-look procedure had better survival rates compared to those with macroscopic disease, highlighting the importance of early detection and effective tumor reduction.

However, long-term chemotherapy led to significant mortality, with 4 patients dying from treatment-related toxicity, particularly those receiving melphalan, indicating a need for careful management of chemotherapy regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of "third-look" laparotomy in the guidance of ovarian cancer treatment. Copeland, LJ., Wharton, JT., Rutledge, FN., et al.[2019]

In a study of 369 patients undergoing gynecological surgeries, 26% experienced adverse events (AEs), leading to an average additional hospitalization cost of AU$12,780 per patient.

Reducing AEs by 40% could potentially save the healthcare system up to AU$20.6 million per year, highlighting the importance of implementing evidence-based interventions to minimize these events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital costs associated with adverse events in gynecological oncology. Kondalsamy-Chennakesavan, S., Gordon, LG., Sanday, K., et al.[2011]

Minimally invasive surgery, including laparoscopic techniques, is becoming increasingly important in the treatment of ovarian cancer, allowing for accurate diagnosis, staging, and potential cytoreduction with less recovery time compared to traditional surgery.

The use of laparoscopic methods has shown promise in various stages of ovarian cancer treatment, including early diagnosis, assessment for surgery, and management of recurrent disease, suggesting that these techniques should be integrated into gynecologic oncology practices and training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of minimally invasive surgery in ovarian cancer. Nezhat, FR., Pejovic, T., Finger, TN., et al.[2014]

Cytoreductive surgery is the best initial treatment for ovarian carcinomas, but additional therapies like chemotherapy and radiotherapy are essential for improving outcomes, especially in advanced cases with incomplete surgical removal.

Chemotherapy is the primary adjuvant treatment for advanced ovarian cancer, while radiotherapy is used to target residual tumor masses, particularly in early-stage cases where surgery has successfully removed the tumor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapeutic indications in the treatment of cancer of the ovary]. Dubois, JB.[2006]

Surgeons experienced in abdominal and pelvic surgery are crucial for managing ovarian cystadenocarcinoma, especially during the initial laparotomy, which aims to assess tumor stage and remove as much tumor tissue as possible.

For stage III cancers, radical surgery has not been shown to improve long-term survival, and a 'second look' laparotomy is only recommended for evaluating tumor residue after chemotherapy, as it does not enhance patient comfort or survival in the absence of effective second-line therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Surgical treatment of ovarian cystadenocarcinoma]. Piana, L.[2006]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Minimally Invasive Surgery Versus Open Laparotomy for Interval Debulking Surgery of Advanced Ovarian Cancer After Neoadjuvant Chemotherapy: A Systematic Review and A Meta-Analysis. [2022]

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

The role of cytoreductive/debulking surgery in ovarian cancer. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Clinical trials in patients with epithelial ovarian cancer: past, present and future. [2019]

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

Conservative surgery for ovarian cancer and effect on fertility. [2019]

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

Surgery in ovarian cancer. [2019]

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

Incidence of Hypersensitivity Reactions to Carboplatin or Paclitaxel in Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer With or Without BRCA1 or BRCA2 Mutations. [2023]

7. France pubmed.ncbi.nlm.nih.gov

[Preoperative chemotherapy of ovarian cancer in anesthesia and resuscitation]. [2016]

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

Role of "third-look" laparotomy in the guidance of ovarian cancer treatment. [2019]

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

Hospital costs associated with adverse events in gynecological oncology. [2011]

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

Role of minimally invasive surgery in ovarian cancer. [2014]

11. France pubmed.ncbi.nlm.nih.gov

[Therapeutic indications in the treatment of cancer of the ovary]. [2006]

12. France pubmed.ncbi.nlm.nih.gov

[Surgical treatment of ovarian cystadenocarcinoma]. [2006]