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Malignant Neoplasm of OvaryMIID-SOCNCT03378128

Debulking Surgery in Ovarian Cancer

A study testing Diagnostic laparoscopy in people with Malignant Neoplasm of Ovary and Malignant Neoplasm of Fallopian Tube, run by Case Comprehensive Cancer Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to see if patients undergoing a laparoscopic surgery for removal of ovarian, fallopian tube, or primary peritoneal cancer following neoadjuvant chemotherapy (neoadjuvant- chemotherapy given before surgery) is feasible, safe, and provides similar outcomes as compared to undergoing a large… Read more about this study

Who is it for?
Ages 19 years and older, women only
What is being tested?
Diagnostic laparoscopy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesUnited States
Study dates
12 Jan 2018to 30 Apr 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must have histologically or cytologically confirmed advanced epithelial ovarian, fallopian tube, or primary peritoneal (≥ International Federation of Gynecology and Obstetrics (FIGO) Stage IIIC)
  • Subjects must have received neoadjuvant chemotherapy (any number of cycles) with complete or partial response as assessed by Response Evaluation Criteria in Solid Tumors 1.1 (RECIST) or CA 125 response by Gynecologic Cancer Intergroup (GCIG) criteria
  • Performance status Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Severe cardiopulmonary disease precluding the use of the minimally invasive technique as deemed by Internal Medicine Preoperative Assessment, Consultant and Treatment (IMPACT)
  • Inability to tolerate prolonged Trendelenburg position as deemed by anesthesiology
  • Severe hip disease precluding the use of dorsolithotomy position
  • Prior pelvic or abdominal radiation
  • Clinically large pelvic masses reaching above the umbilicus
  • Absence of a documented PR or CR according to RECIST 1.1 or CA 125 response by GCIG criteria to neoadjuvant chemotherapy
  • Presence of parenchymal liver metastases on imaging
  • Absence of baseline imaging studies (CT abdomen/pelvis and Chest x-ray minimum) both prior to beginning chemotherapy and following chemotherapy

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Atrium/Charlotte-Mecklenburg Hospital Authority

    Charlotte, North Carolina, 28203

  • Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: Minimally Invasive Interval Debulking Surgery in Ovarian Cancer

The purpose of this study is to see if patients undergoing a laparoscopic surgery for removal of ovarian, fallopian tube, or primary peritoneal cancer following neoadjuvant chemotherapy (neoadjuvant- chemotherapy given before surgery) is feasible, safe, and provides similar outcomes as compared to undergoing a large abdominal incision. Minimally invasive, or laparoscopic, surgery is a type of surgery where only small incisions are made on the abdomen and surgical instruments are placed through these incisions to perform the surgery. This type of surgery has been shown to improve outcomes in many types of surgery, including in gynecologic cancer surgery. Specifically, researchers know that patients who have minimally invasive surgery have less pain after surgery, can go home quicker from the hospital, healing time is more rapid, and potentially this can translate into returning to chemotherapy sooner. Specifically, in ovarian, fallopian tube, and primary peritoneal cancer, minimally invasive surgery has not been used as much because these cancers can have tumors all throughout the inside of the abdomen (i.e. wide tumor burden) and located in areas that are sometimes not easily reachable with laparoscopic instruments. However, the reason patients receive neoadjuvant chemotherapy is to shrink the tumor/s to make the surgery less extensive and the recovery easier. It is unknown if minimally invasive surgery can be used in this setting and by studying this, the study team will be able to determine if patient outcomes are improved by implementing (using) this surgical technique.

Read the detailed description

The objective of this study is to implement, evaluate, and further investigate the role of minimally invasive surgery in patients undergoing interval debulking following neoadjuvant chemotherapy in patients with advanced ovarian cancer.

Primary Objective:

Prospectively evaluate the feasibility and safety of the minimally invasive interval debulking approach

Secondary Objective(s)

  1. Identify the patient population for which the minimally invasive interval debulking approach will offer comparable, if not improved, outcomes as the laparotomic interval debulking technique
  2. Validate previously identified preoperative imaging computed tomography (CT) criteria and CA-125 values to predict optimal cytoreduction in laparotomic primary cytoreductive surgery and apply it towards the prediction of optimal cytoreduction (≤ 1 cm residual disease) following minimally invasive interval debulking surgery
  3. Validate the previously identified laparoscopic scoring system for primary cytoreductive surgery and apply it towards the prediction of optimal cytoreduction (≤ 1 cm residual disease) following minimally invasive interval debulking surgery
  4. Monitor the number of hospital days in the first 30 days postoperatively (length of stay after interval debulking including any days of readmission)
  5. Evaluate the oncologic safety as it relates to time to return to chemotherapy in patients who undergo laparoscopic minimally invasive interval debulking surgery
  6. Evaluate the complications as assessed by incidence of a composite of major complications and a second composite of minor complications

Study Design This will be a prospective pilot study to address feasibility and safety to identify a patient population amenable to this surgical approach. This will allow for the future trial to include randomization

Being tested
Diagnostic laparoscopy
Keywords
debulking surgery, Ovarian Cancer
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diagnostic laparoscopyProcedure or surgery

    The patient will initially undergo a diagnostic laparoscopy by a minimally invasive approach and entry method. The decision of which approach and entry to perform will be dictated by the primary surgeon of record's preference and their assessment of pre-operative patient factors. Once the primary surgeon determines the areas of macroscopic disease, he/she will make an assessment as to the need to convert to a laparotomy or continue laparoscopically. At the completion of the procedure, it will be noted whether an optimal cytoreduction (≤ 1 cm residual disease) or a sub-optimal cytoreduction (>1 cm residual disease) was performed.

Study groups in NCT03378128
Study groupRoleWhat they receive
diagnostic laparoscopic assessment after neoadjuvant chemoExperimentalAll patients will undergo a diagnostic laparoscopic assessment of disease following neoadjuvant chemotherapy
Receives: Procedure: Diagnostic laparoscopy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients who undergo minimally-invasive interval debulking surgery (MI-IDS) among all patients enrolled in the study

    Feasibility measure

    Measured: 1 day

  2. Percentage of patients experiencing grade 3 or 4 post-operative complications

    Accordion Severity Grading system with grade 3-4 scores. Grade 3 and 4 are severe complications or death. Severe complications are those requiring endoscopic or interventional radiologic procedures or re-operation as well as complications resulting in failure of 1 or more organ system. If fewer than 14% of patients have grade 3 or 4 complications, the surgery will be deemed safe.

    Measured: 30 days post-surgery

Secondary outcomes (6)

  1. Percentage of patients with optimal cytoreductive surgery (=< 1cm of disease seen at completion of surgery)

    Rate of optimal resection after interval debulking surgery is expected to be between 73%-81%

    Measured: 1 day

  2. Proportion of patients who have a laparoscopy at the outset and remain laparoscopic throughout their surgery

    If greater than 13 of the 50 patients planned to be enrolled on the study complete the laparoscopic surgery, the study will be deemed feasible

    Measured: 1 day

  3. Length of hospital stay

    Time from the end of surgery to when the patient is discharged

    Measured: Up to 30 days after surgery

  4. Time to return to chemotherapy

    From the time of surgery to when the patient returns to chemotherapy treatments. Shorter times between surgery and chemotherapy are positive outcomes

    Measured: 30 days after surgery

  5. Score of the Bristow preoperative predictive index parameters

    23 point index where higher scores indicate poorer outcomes

    Measured: 1 day

  6. Score of Suidan preoperative predictive index parameters

    17 point index where higher scores indicate poorer outcomes

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2017
  2. Study start12 Jan 2018
  3. Primary completion30 Apr 2020
  4. Study completion30 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03378128
Sponsor's protocol ID
CASE9817
Acronym
MIID-SOC
Status last verified
Mar 2022
First submitted
15 Dec 2017
Last updated
14 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Costales AB, Crane EK, Chambers L, Yao M, Chau D, Naumann WR, Debernardo R, Ricci S, Rose PG, Michener CM. Laparoscopic predictability of minimally invasive interval debulking in advanced ovarian cancer: The MIID-SOC trial. Gynecol Oncol. 2024 Jun;185:143-147. doi: 10.1016/j.ygyno.2024.02.019. Epub 2024 Feb 27.

    PubMed 38417209

Questions about this trial

What is this clinical trial studying?

A study testing Diagnostic laparoscopy in people with Malignant Neoplasm of Ovary and Malignant Neoplasm of Fallopian Tube, run by Case Comprehensive Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients who undergo minimally-invasive interval debulking surgery (MI-IDS) among all patients enrolled in the study (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03378128, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2022.

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