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Rectosigmoid Resection vs Seromuscular Tumor Shaving in Ovarian Cancer Surgery

Primary Purpose

Epithelial Ovarian Cancer, Rectosigmoid Cancer Metastatic

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Rectosigmoid resection
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epithelial Ovarian Cancer focused on measuring epithelial ovarian cancer, Rectosigmoid resection, Seromuscular tumor shaving, recurrence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Epithelial ovarian cancer
  • Negative colonoscopy ( no mucosal involvement)
  • Intraoperative confirmed serosal or seromuscular rectosigmoid infiltration
  • ECOG <3
  • ASA <3

Exclusion Criteria:

  • Nonepithelial ovarian cancers
  • Rectosigmoid mucosal infiltration
  • Total or subtotal colectomy necessitating large bowel infiltrations
  • ECOG >2
  • ASA >2

Sites / Locations

  • Cukurova University
  • Cukurova UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Rectosigmoid resection

Rectosigmoid seromuscular tumor shaving

Arm Description

Outcomes

Primary Outcome Measures

Local pelvic recurrence
Only the pelvic recurrences determined after the last chemotherapy cycle.
Recurrence-free survival
The time from the last chemotherapy cycle to determination of any recurrence in any location.

Secondary Outcome Measures

Cancer specific survival
Time from diagnosis to the death date due to ovarian cancer.
Surgery related morbidities
Any surgery related morbidity during 90 days.
Health related Quality of life
HRQoL will be assessed with the European Organization for Research and Treatment of Cancer (EORTC) core questionnaire (EORTC QLQ-C30 version 3.0).The QLQ-C30 is a 30-item questionnaire that includes five multiitem functional scales (physical, role, cognitive, emotional, and social), three multi-item symptom scales (fatigue, nausea and vomiting, and pain), five single-item symptom scales (dyspnoea, insomnia, appetite loss, constipation, and diarrhoea), a question on financial impact; and a two-item global quality of life scale.The questionnaire generally has a four-point response scale (1 = "not at all", 4 = "very much").The questionnaire is planned to be performed within 1-2 weeks prior to the surgery (baseline), after 3-4 weeks of surgery before starting of adjuvant chemotherapy, at the end of adjuvant chemotherapy, and every three months in follow-up, until two years of follow-up.
Overall survival
Time from diagnosis to the death date due to any cause.

Full Information

First Posted
November 30, 2020
Last Updated
February 7, 2023
Sponsor
Cukurova University
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1. Study Identification

Unique Protocol Identification Number
NCT04665635
Brief Title
Rectosigmoid Resection vs Seromuscular Tumor Shaving in Ovarian Cancer Surgery
Official Title
Comparison of Rectosigmoid Resection and Seromuscular Tumor Shaving Methods in Ovarian Cancer Surgery (BROSEOC)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Ovarian cancer is the most common cause of death in gynecological cancer. Approximately 75% of epithelial ovarian cancers are detected at an advanced stage. Metastasis and spread are mostly through transperitoneal planting and neighborhood by shedding from the ovarian surface. Metastasis mostly occurs in the peritoneum, omentum, and intestines. The rectosigmoid colon is the main part of the intestine affected by metastasis due to its neighborhood. Treatment in ovarian cancer consists of a combination of cytoreduction surgery and platinum-based chemotherapy. Surgery is the basis of the treatment, and the main goal is to achieve no residual visible tumor (complete cytoreduction: R0). The residual tumor is one of the main factors affecting survival and reflects the possibilities of the surgical center and the team. Multiple surgical procedures (total hysterectomy, bilateral salpingo-oophorectomy, total omentectomy, peritonectomy, retroperitoneal lymphadenectomies such as pelvic and paraaortic, bowel resections, splenectomy, distal pancreatectomy, various resections related to the bladder, liver, stomach, and diaphragm) may be required to achieve complete or optimal cytoreduction. In the involvement of the rectosigmoid colon, primarily the serosa, then the muscular layer and finally the mucosa are infiltrated due to the nature of the spread, and therefore most of the involvement is observed in the seromuscular layer. In seromuscular infiltration, resection of the rectosigmoid colon or shaving of tumoral implants without resection can be performed. There are advantages and disadvantages of each method in terms of morbidity. Although there are retrospective studies evaluating recurrence and survival between both methods, as far as investigators know, no randomized prospective studies have been conducted comparing these two methods. The investigators designed this study to compare these two methods successfully applied in our clinic in a prospective randomized study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer, Rectosigmoid Cancer Metastatic
Keywords
epithelial ovarian cancer, Rectosigmoid resection, Seromuscular tumor shaving, recurrence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rectosigmoid resection
Arm Type
Active Comparator
Arm Title
Rectosigmoid seromuscular tumor shaving
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Rectosigmoid resection
Other Intervention Name(s)
Rectosigmoid seromuscular tumor shaving
Intervention Description
Most of the colorectal involvements are observed in the seromuscular layer. In seromuscular infiltration, resection of the rectosigmoid colon or shaving of tumoral implants without resection can be performed.
Primary Outcome Measure Information:
Title
Local pelvic recurrence
Description
Only the pelvic recurrences determined after the last chemotherapy cycle.
Time Frame
0-60 months.
Title
Recurrence-free survival
Description
The time from the last chemotherapy cycle to determination of any recurrence in any location.
Time Frame
0-60 months.
Secondary Outcome Measure Information:
Title
Cancer specific survival
Description
Time from diagnosis to the death date due to ovarian cancer.
Time Frame
0-100 months
Title
Surgery related morbidities
Description
Any surgery related morbidity during 90 days.
Time Frame
90 days.
Title
Health related Quality of life
Description
HRQoL will be assessed with the European Organization for Research and Treatment of Cancer (EORTC) core questionnaire (EORTC QLQ-C30 version 3.0).The QLQ-C30 is a 30-item questionnaire that includes five multiitem functional scales (physical, role, cognitive, emotional, and social), three multi-item symptom scales (fatigue, nausea and vomiting, and pain), five single-item symptom scales (dyspnoea, insomnia, appetite loss, constipation, and diarrhoea), a question on financial impact; and a two-item global quality of life scale.The questionnaire generally has a four-point response scale (1 = "not at all", 4 = "very much").The questionnaire is planned to be performed within 1-2 weeks prior to the surgery (baseline), after 3-4 weeks of surgery before starting of adjuvant chemotherapy, at the end of adjuvant chemotherapy, and every three months in follow-up, until two years of follow-up.
Time Frame
0-24 months.
Title
Overall survival
Description
Time from diagnosis to the death date due to any cause.
Time Frame
0-100 months.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Epithelial ovarian cancer Negative colonoscopy ( no mucosal involvement) Intraoperative confirmed serosal or seromuscular rectosigmoid infiltration ECOG <3 ASA <3 Exclusion Criteria: Nonepithelial ovarian cancers Rectosigmoid mucosal infiltration Total or subtotal colectomy necessitating large bowel infiltrations ECOG >2 ASA >2
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ghanim Khatib, MD
Phone
+903223386060
Email
ghanim.khatib@gmail.com
Facility Information:
Facility Name
Cukurova University
City
Adana
ZIP/Postal Code
01330
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghanim Khatib, MD
Phone
03223386060
Email
ghanim.khatib@gmail.com
First Name & Middle Initial & Last Name & Degree
Ghanim Khatib, MD
Phone
+903223386060
Ext
Khatib
Email
ghanim.khatib@gmail.com
First Name & Middle Initial & Last Name & Degree
Ghanim Khatib, MD,Ass.Prof
Facility Name
Cukurova University
City
Adana
ZIP/Postal Code
01330
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ganim Khatib, MD, MSc
Phone
+9005326745044
Email
ghanim.khatib@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
30371561
Citation
Erkilinc S, Karatasli V, Demir B, Cakir I, Can B, Karadeniz T, Gokcu M, Sanci M. Rectosigmoidectomy and Douglas Peritonectomy in the Management of Serosal Implants in Advanced-Stage Ovarian Cancer Surgery: Survival and Surgical Outcomes. Int J Gynecol Cancer. 2018 Nov;28(9):1699-1705. doi: 10.1097/IGC.0000000000001368.
Results Reference
background
PubMed Identifier
21945640
Citation
Gallotta V, Fanfani F, Vizzielli G, Panico G, Rossitto C, Gagliardi ML, Margariti PA, Salerno MG, Zannoni GF, Pacelli F, Scambia G, Fagotti A. Douglas peritonectomy compared to recto-sigmoid resection in optimally cytoreduced advanced ovarian cancer patients: analysis of morbidity and oncological outcome. Eur J Surg Oncol. 2011 Dec;37(12):1085-92. doi: 10.1016/j.ejso.2011.09.003. Epub 2011 Sep 25.
Results Reference
result
PubMed Identifier
17000396
Citation
Aletti GD, Podratz KC, Jones MB, Cliby WA. Role of rectosigmoidectomy and stripping of pelvic peritoneum in outcomes of patients with advanced ovarian cancer. J Am Coll Surg. 2006 Oct;203(4):521-6. doi: 10.1016/j.jamcollsurg.2006.06.027. Epub 2006 Aug 23.
Results Reference
result

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Rectosigmoid Resection vs Seromuscular Tumor Shaving in Ovarian Cancer Surgery

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