Peritoneal carcinomatosis in patients with ovarian cancer is frequently observed and its management is so difficult. This study aimed to investigate the effect of cytoreduction and intraperitoneal chemotherapy using peritoneal port in 20 patients with peritoneal seeding post to ovarian cancer. Patients with peritoneal carcinomatosis post to ovarian cancer which will be confirmed in biopsy are included. Exclusion criteria are as follows: patient intolerance, pulmonary metastasis and systemic metastasis. It is anticipated that this procedure will result in longer survival and reduced morbidity because of peritoneal invasion.
General information
Acronym
SORC Study
IRCT registration information
IRCT registration number:IRCT201112088331N1
Registration date:2012-06-06, 1391/03/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-06-06, 1391/03/17
Registrant information
Name
Abbas Abdollahi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1802 2677
Email address
abdollahia@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2011-10-19, 1390/07/27
Expected recruitment end date
2013-10-19, 1392/07/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of cytoreductive surgery and intraperitoneal chemotherapy in the peritoneal carcinomatosis
Public title
Evaluating the effect of reducing the number of cancer cells and intraperitoneal chemotherapy in patients with advanced peritoneal carcinoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with primary ovarian cancer who have not been previously treated for the cancer and in whom abdominal carcinomatosis is confirmed before or during surgical interventions. Exclusion criteria: Patient dissatisfaction; Patient intolerance;Lymph node metastasis; Systemic metastasis; No cytoreductive surgery (residue less than 1 cm); PS< 80%; Age> 70 years; Adhesions which are resistant to enterolysis.
Age
To 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Ghoreyshi Building, Daneshgah Street
City
Mashhad
Postal code
9133913716
Approval date
2011-10-19, 1390/07/27
Ethics committee reference number
89229
Health conditions studied
1
Description of health condition studied
Neoplasm
ICD-10 code
C56
ICD-10 code description
Malignant neoplasm of ovary
Primary outcomes
1
Description
Disease- free survival
Timepoint
At intervals of 6 and 9 months, and then every 3 months up to 5 yeras after intervention
Method of measurement
Month
Secondary outcomes
1
Description
Intraperitoneal recurrence
Timepoint
In follow up studies
Method of measurement
Clinical or Paraclinical
2
Description
Surgical Complications
Timepoint
In early follow up studies
Method of measurement
Clinical or Paraclinical
3
Description
Ovarian cancer
Timepoint
In the follow up studies
Method of measurement
In biopsy
Intervention groups
1
Description
Cytoreductive surgery and intraperitoneal chemotherapy
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Abbas Abdollahi
Street address
Surgical Oncology Research Center, Imam Reza Hospital, Faculty of Medicine, Mashhad University of Medical Sciences
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Ghoreyshi Building, Daneshgah Street
City
Mashhad
Grant name
Grant code / Reference number
89229
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Abbas Abdollahi
Position
Assistant Professor of Surgery
Other areas of specialty/work
Street address
Surgical Oncology Research Center, Imam Reza Hospital, Faculty of Medicine, Mashhad University of Medical Sciences
City
Mashhad
Postal code
9133913716
Phone
+98 51 1802 2677
Fax
Email
abdollahia@mums.ac.ir; surg.rc@mums.ac.ir
Web page address
http://www.mums.ac.ir/sorc/en/index
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Abbas Abdollahi
Position
Assistant Professor
Other areas of specialty/work
Street address
Surgical Oncology Research Center, Imam Reza Hospital, Faculty of Medicine, Mashhad University of Medical Sciences
City
Mashhad
Postal code
9137913316
Phone
+98 51 1802 2677
Fax
Email
abdollahia@mums.ac.ir; surg.rc@mums.ac.ir
Web page address
http://www.mums.ac.ir/sorc
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)