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Comparison the results of combination platinium based neoadjuvant chemotherapy regimens using gemcitabin/ciplatin with carboplatin/paclitaxel in advanced stage ovarian cancer patients; A RCT

Protocol summary

Summary
The objective of this randomized, clinical trial is to investigate the results of combination platinium based neoadjuvant chemotherapy regimens using gemcitabin/cisplatin or carboplatin/paclitaxelin in advanced stage serous ovarian cancer patients, who have been undergone interval cytoreductive surgery and evaluation of intraoperative and early postoperative complications. In this study, 206 patients with advanced serous ovarian cancer, Figo stage III and IV, and ascites volume more than 500cc which was found by ultrasonography and CT SCAN, and meet the inclusion/exclusion criteria will be recruited and randomly assigned into intervention groups. Histologic diagnosis will be made by paracentesis. The patients in the first group will receive gemcitabin/cisplatin but those in the second group will receive carboplatin/paclitaxel. First, in each group, chemotherapy is done for three cycles, then interval cytoreductive surgery is carried out and primary outcome measures will be evaluated with the measurement of preoperative CA-125 levels, diameter of target lesions, the volume of residual tumor , the volume of ascites , amount of bleeding during surgery, surgery duration and death during surgery .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201203225283N3
Registration date: 2012-06-28, 1391/04/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-06-28, 1391/04/08
Registrant information
Name
Manizheh Sayyah Melli
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 3741
Email address
sayyahmellim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences
Expected recruitment start date
2009-11-22, 1388/09/01
Expected recruitment end date
2011-01-20, 1389/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the results of combination platinium based neoadjuvant chemotherapy regimens using gemcitabin/ciplatin with carboplatin/paclitaxel in advanced stage ovarian cancer patients; A RCT
Public title
Comparison the results of combination platinium based neoadjuvant chemotherapy regimens using gemcitabin/ciplatin with carboplatin/paclitaxel in advanced stage ovarian cancer patients; A RCT
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients with advanced serous ovarian cancer Figo Stage III and IV; the volume of ascites, that is determined by ultrasound or CT scan, more than 500cc
Age
From 20 years old to 90 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 206
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of medical Sciences
Street address
Golgasht Ave., Vice Chancellor deputy of Research, Tabriz University of medical Sciences
City
Tabriz
Postal code
Approval date
2011-05-24, 1390/03/03
Ethics committee reference number
2537/4/5

Health conditions studied

1

Description of health condition studied
Patients with advanced serous ovarian cancer, Figo stage III and IV
ICD-10 code
c56
ICD-10 code description
Malignant neoplasm of ovary

Primary outcomes

1

Description
CA-125 levels
Timepoint
before surgery
Method of measurement
Lab measurement

2

Description
The volume of residual tumor
Timepoint
During surgery
Method of measurement
Clinical judgment

3

Description
The volume of ascites
Timepoint
During surgery
Method of measurement
Clinical estimation

4

Description
Bleeding
Timepoint
During surgery
Method of measurement
Clinical estimation

5

Description
Surgery duration
Timepoint
During surgery
Method of measurement
During surgery

6

Description
Death during surgery
Timepoint
During surgery
Method of measurement
observation

Secondary outcomes

1

Description
wound infection, dehicsence, nausea, vomiting,diarrhea, illeus, intestinal obstruction, hospital stay
Timepoint
24 h after surgery
Method of measurement
observation, ultrasonography, CT-scan

2

Description
ascites collection
Timepoint
24 hours after surgery
Method of measurement
observation, ultrasonography, CT-scan

Intervention groups

1

Description
For first group, at first daycombination ofgemcitabin (1000 mg per square meter on days 1 and 8 IV during 30 minutes) and cisplatin (75 mg per square meter, IV) are administrated. This protocol can be repeated every 21 days. This protocol is repeated every 21 days, and up to 3 courses of chemotherapy is done. Then patients undergo immediate interval debulking surgery.
Category
Treatment - Drugs

2

Description
For group 2, combination of carboplatin (carboplatin at an area under the concentration-time curve (AUC) of 5-6 mg/mL/min IV over 1 hour and paclitaxel (175 mg per square meter IV over 3 hours) on the first day will be prescribed. This protocol is repeated every 21 days, and up to 3 courses of chemotherapy is done. Then patients undergo immediate interval debulking surgery.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Women's Reproductive Health Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Elaheh Ouladsahebmadarek
Street address
Alzahra Hospital, South ArteshAve.,Tabriz, Iran.
City
Tabriz
Grant name
10506
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Women's Reproductive Health Research Center, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Manizheh Sayyah-Melli
Position
Full Professor
Other areas of specialty/work
Street address
South ArteshAve.,Tabriz, Iran.
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
manizheh.sayyahmelli@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Manizheh sayyah-melli
Position
Full Professor
Other areas of specialty/work
Street address
South ArteshAve.,Tabriz, Iran.
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
manizheh.sayyahmelli@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Manizheh Sayyah-Melli
Position
full prof of Ob & Gyn, fellowship of gynecologic oncology, head of oncology department
Other areas of specialty/work
Street address
Alzahra Hospital, South Artesh Ave.,
City
Tabriz
Postal code
5138665793
Phone
+98 41 1554 1221
Fax
+98 41 1554 1221
Email
manizheh.sayyahmelli@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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