Epithelial Ovarian CancerPhase 2NCT02595021
Total/Subtotal Colectomy in Ovarian Cancer
A Phase 2 study testing Total or Subtotal Colectomy and Other Bowel Resection in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Shanghai Gynecologic Oncology Group at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and one year disease-free survival of total or subtotal colectomy and proctocolectomy in stage IIIc and stage IV epithelial ovarian, fallopian tube, and primary peritoneal cancer (EOC, FTC, PPC). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
- What is being tested?
- Total or Subtotal Colectomy and Other Bowel Resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to Dec 2018
- Phase
- Phase 2
- 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 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years and ≤ 75 years.
- Epithelial ovarian cancer, fallopian tube cancer, primary peritoneal carcinoma with pathology confirmed International Federation of Gynecology and Obstetrics (FIGO) stage IIIc or IV
- Extensive colonic metastasis, tumor involving the major part of bowel surface and/or mesentery
- Optimal cytoreductive surgery, including hysterectomy, bilateral salpinges-oophorectomy, omentectomy, and resection of all metastatic lesions, with a residual disease no more than 0.5cm
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- American Society of Anesthesiologists (ASA) performance 1-2.
- Follow-up available.
- Written informed consent.
Who cannot join
- Low-malignant potential ovarian tumor.
- Patient who underwent enterostomy in the surgery procedure.
- Tumor involving small intestine alone.
- More than 2 anastomoses.
- Other condition that could interfere with provision of informed consent, compliance to study procedures, or follow-up.
- Prior invasive malignancies within the last 5 years showing activity of disease.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Zhuozhen Sun, MD, +862164041990, zhuozhen_sun@hotmail.com
Yuting Luan, RN, +862164041990, yutingluan@163.com
About this study
Official title: A Phase II Study of Total or Subtotal Colectomy in Stage IIIC and Stage IV Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (EOC, FTC, PPC)
The purpose of this study is to evaluate the safety and one year disease-free survival of total or subtotal colectomy and proctocolectomy in stage IIIc and stage IV epithelial ovarian, fallopian tube, and primary peritoneal cancer (EOC, FTC, PPC).
Read the detailed description
This trial is to assess the perioperative complications, hospitalization expenses and days, and one year disease-free survival of patients who underwent total or subtotal colectomy as part of the surgical procedures for ovarian cancer, versus partial intestinal resection in the therapy for ovarian cancer.
- Conditions
- Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Secondary Malignant Neoplasm of Large Intestine
- Being tested
- Total or Subtotal Colectomy, Other Bowel Resection
- Keywords
- Total or subtotal colectomy, Ovarian cancer, Complications, One-year disease-free survival, Stage IIIc, Stage IV
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total or Subtotal ColectomyProcedure or surgery
Also called Radical surgery, Total Colectomy, Subtotal Colectomy
Resect all or most parts of the colon: with total or subtotal colectomy as a part of optimal cytoreductive surgery(residual disease <=0.5cm)
Other Bowel ResectionProcedure or surgery
Also called Partial Colectomy, Small bowel resection
Resect part of the colon or small intestine: with other types of bowel resection as a part of optimal cytoreductive surgery(residual disease <=0.5cm)
| Study group | Role | What they receive |
|---|---|---|
| Total or Subtotal Colectomy | Experimental | all patients who underwent total colectomy(removal of the large intestine from ileum to the rectum. After it is removed, the end of the small intestine is sewn to the rectum) or subtotal colectomy(removal of transverse colon, descending colon, sigmoid colon to the rectum. After it is removed, the end of the ascending colon is sewn to the rectum)as part of optimal cytoreductive surgery Receives: Procedure: Total or Subtotal Colectomy |
| Other Bowel Resection | Active comparator | all patients who underwent partial intestinal resection as part of optimal cytoreductive surgery Receives: Procedure: Other Bowel Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Assessed by Common Terminology Criteria for Adverse Events version 4.0 up to 30 days after surgery
Measured: up to 30 days after surgery
Secondary outcomes (4)
The rate of 12- month- disease non-progression
Number of patients without progression in 12 months (From date of first chemotherapy until the date of first documented progression, assessed up to 12 months)
Measured: up to 12 months
Initiation of the first cycle chemotherapy
To compare the date between surgery and initiation of the first cycle chemo
Measured: up to 12 weeks
Hospitalization expenses
the cost during hospital stay
Measured: up to 12 weeks
Hospitalization days
length of hospital stay
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Gynecologic Oncology Group
- Sponsor type
- Other government
- Collaborators
- Shanghai Zhongshan Hospital
- Responsible party
- Sponsor
- Investigators
- Rongyu Zang, MD,PhD, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595021
- Sponsor's protocol ID
- zsfud-obgyn-004
- Status last verified
- Jul 2016
- First submitted
- 18 Sep 2015
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Total or Subtotal Colectomy in Stage IIIC and Stage IV Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (EOC, FTC, PPC)
- ClinicalTrials.gov ID
- NCT02595021
- Acronym / sponsor ID
- zsfud-obgyn-004
- Conditions
- Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma, Secondary Malignant Neoplasm of Large Intestine
- Keywords
- Total or subtotal colectomy, Ovarian cancer, Complications, One-year disease-free survival, Stage IIIc, Stage IV
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shanghai Gynecologic Oncology GroupOther government
- Collaborators
- Shanghai Zhongshan Hospital
- Study start
- Jul 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and one year disease-free survival of total or subtotal colectomy and proctocolectomy in stage IIIc and stage IV epithelial ovarian, fallopian tube, and primary peritoneal cancer (EOC, FTC, PPC).
Detailed description
This trial is to assess the perioperative complications, hospitalization expenses and days, and one year disease-free survival of patients who underwent total or subtotal colectomy as part of the surgical procedures for ovarian cancer, versus partial intestinal resection in the therapy for ovarian cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total or Subtotal Colectomy | Experimental | Procedure: Total or Subtotal Colectomyall patients who underwent total colectomy(removal of the large intestine from ileum to the rectum. After it is removed, the end of the small intestine is sewn to the rectum) or subtotal colectomy(removal of transverse colon, descending colon, sigmoid colon to the rectum. After it is removed, the end of the ascending colon is sewn to the rectum)as part of optimal cytoreductive surgery |
| Other Bowel Resection | Active comparator | Procedure: Other Bowel Resectionall patients who underwent partial intestinal resection as part of optimal cytoreductive surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years and ≤ 75 years.
- Epithelial ovarian cancer, fallopian tube cancer, primary peritoneal carcinoma with pathology confirmed International Federation of Gynecology and Obstetrics (FIGO) stage IIIc or IV
- Extensive colonic metastasis, tumor involving the major part of bowel surface and/or mesentery
- Optimal cytoreductive surgery, including hysterectomy, bilateral salpinges-oophorectomy, omentectomy, and resection of all metastatic lesions, with a residual disease no more than 0.5cm
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Key exclusion criteria (6 listed)
- Low-malignant potential ovarian tumor.
- Patient who underwent enterostomy in the surgery procedure.
- Tumor involving small intestine alone.
- More than 2 anastomoses.
- Other condition that could interfere with provision of informed consent, compliance to study procedures, or follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total or Subtotal ColectomyAlso: Radical surgery, Total Colectomy, Subtotal ColectomyResect all or most parts of the colon: with total or subtotal colectomy as a part of optimal cytoreductive surgery(residual disease <=0.5cm) | Procedure or surgery | Total or Subtotal Colectomy |
| Other Bowel ResectionAlso: Partial Colectomy, Small bowel resectionResect part of the colon or small intestine: with other types of bowel resection as a part of optimal cytoreductive surgery(residual disease <=0.5cm) | Procedure or surgery | Other Bowel Resection |
Primary outcome
Postoperative complications
Time frame: up to 30 days after surgery
Assessed by Common Terminology Criteria for Adverse Events version 4.0 up to 30 days after surgery
4 secondary outcomes
The rate of 12- month- disease non-progression
Time frame: up to 12 months
Initiation of the first cycle chemotherapy
Time frame: up to 12 weeks
Hospitalization expenses
Time frame: up to 12 weeks
Hospitalization days
Time frame: up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Shanghai Gynecologic Oncology GroupLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rongyu Zang, MD,PhD principal investigator
Shanghai Zhongshan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Total or Subtotal Colectomy and Other Bowel Resection in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Shanghai Gynecologic Oncology Group at 1 site in China.
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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhuozhen Sun, MD (+862164041990, zhuozhen_sun@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: up to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2016.