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Trial registered on ANZCTR


Registration number
ACTRN12606000502538
Ethics application status
Approved
Date submitted
30/11/2006
Date registered
5/12/2006
Date last updated
11/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Study to determine the possibility of treating women with ovarian and related cancers with chemotherapy, some of which is given directly into the abdomen as well as into the vein. It will also determine how safe it is, what side-effects it causes and how it affects quality of life.
Scientific title
A Single Arm Phase II Trial of Intraperitoneal Chemotherapy with Paclitaxel and Cisplatin after Optimal Debulking Surgery for Ovarian, Peritonuem and Fallopian Tube Cancers assessing the feasibility, toxicity and effects on quality of life of a modified GOG 172 (Gynaecologic Oncology Group) intraperitoneal (IP) regimen.
Secondary ID [1] 319 0
Australia and New Zealand Gynecological Oncology Group: ANZGOG 0601
Secondary ID [2] 253000 0
Australia New Zealand Gynaecological Oncology Group (ANZGOG) 0601
Universal Trial Number (UTN)
Trial acronym
TRIPOD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 1478 0
Peritoneum Cancer 1479 0
Fallopian tube Cancer 1480 0
Cancer of the ovary, peritonuem and fallopian tube 258550 0
Condition category
Condition code
Cancer 1574 1574 0 0
Ovarian and primary peritoneal
Cancer 258695 258695 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
IP catheter either at or within 6 weeks of primary surgery.
Trial registration following catheter insertion.
Chemotherapy Regimen
Paclitaxel 135mg/m2 IV (Intravenous) over 3 hours (Day 1)
Cisplatin 75mg/m2 IP (Day 2)
Paclitaxel 60mg/m2 IP (Day 8)
Treatment will consist of 6 cycles given at 3 weekly intervals
Intervention code [1] 1482 0
Treatment: Drugs
Intervention code [2] 257526 0
Treatment: Drugs
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259557 0
To determine the feasibility of giving treatment as prescribed. Feasibility will include the number of cycles of treatment received, the dose intensity and requirement for dose modification (delay, reduction, omission).
Timepoint [1] 259557 0
Outcome checked after treatment given. Treatment is given for 6 cycles given at 3 weekly intervals
Secondary outcome [1] 3790 0
1.Rates of toxicities from treatment particularly neurological, renal and GI toxicities.
Timepoint [1] 3790 0
Analyses will be performed 8 weeks after the 15th and 35th patients have completed 4 cycles of treatment and at study completion. Reports will be reviewed on an ongoing basis by the study chair and TMC (Trial Management Committee).
Secondary outcome [2] 3791 0
2.Rates of catheter complications.
Timepoint [2] 3791 0
Analyses will be performed 8 weeks after the 15th and 35th patients have completed 4 cycles of treatment and at study completion. Reports will be reviewed on an ongoing basis by the study chair and TMC (Trial Management Committee).
Secondary outcome [3] 3792 0
3.Effects of treatment on quality of life.
Timepoint [3] 3792 0
Analyses will be performed 8 weeks after the 15th and 35th patients have completed 4 cycles of treatment and at study completion.
Secondary outcome [4] 3793 0
4.Progression free survival.
Timepoint [4] 3793 0
Progression free survival will be assessed at 6, 9 and 12 months from date of registration.
Secondary outcome [5] 3794 0
5.Intraperitoneal distribution of IP therapy (a sub-set of patients will be offered enrolment in a nuclear medicine sub-study).
Timepoint [5] 3794 0
IP distribution will be assessed at baseline and at cycles 1, 3 and 5.

Eligibility
Key inclusion criteria
1.Stage III epithelial ovarian cancer, primary peritoneal cancer or primary fallopian tube cancers.2.Optimal surgical debulking with residual disease = 1cm.3.IP catheter in-situ4.Platelets = 100 X 109/L; Absolute Neutrophil Count (ANC) = 1.5 X 109/L5.Serum creatinine = 1.5 UNL (Upper Normal Limit) and creatinine clearance (CRCL) = 55ml/min (as calculated by Cockroft-Gault formula; Appendix 2).6.Serum bilirubin = 1.5 UNL and ALT (Amino Alanine Transferase) , Alk Phos (Alkaline Phosphatase) = 3 UNL7.ECOG PS (Eastern Cooperative Oncology Group Performance Status) 0,1 or 28.Able to commence treatment within 6 weeks of primary surgical treatment9.Informed consent obtained.
Minimum age
18 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Invasive cancer within the last 5 years other than basal cell or localized squamous cell carcinoma of the skin.2.Significant intercurrent illness that will interfere with the chemotherapy during the trial such as a.Known HIV (Human Immunodeficiency Virus) infection b.Active infectionc.Myocardial infarction within the previous 6 months or significant cardiac disease resulting in an inability to tolerate the intravenous fluid load as required for administration of cisplatind.Severe lung disease which in the investigators opinion would limit the patients ability to tolerate large volumes of intra-abdominal fluids.3.Any grade I or greater peripheral neuropathy (NCI CTC version 3.0).4.Clinically significant sensori-neural hearing impairment or tinnitus which may be exacerbated by cisplatin (Audiometric abnormalities without corresponding clinical deafness will not be grounds for exclusion).5.Previous cytotoxic chemotherapy for malignancy6.Previous abdominal or pelvic radiation treatment.7.Significant intra-abdominal adhesions as determined by the surgeon at time of primary surgery.8.Rectosigmoid or left colon resection at time of primary debulking surgery.9.Active intraabdominal sepsis10.Medical or psychiatric condition that compromises the patients ability to give informed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/11/2006
Actual
14/09/2007
Date of last participant enrolment
Anticipated
Actual
11/12/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1717 0
Other Collaborative groups
Name [1] 1717 0
ANZGOG Australia New Zealand Gynaecological Oncology Group)
Country [1] 1717 0
Australia
Funding source category [2] 1718 0
University
Name [2] 1718 0
University of Sydney
Country [2] 1718 0
Australia
Primary sponsor type
University
Name
ANZGOG, University of Sydney
Address
NHMRC Clinical Trials Centre
The University of Sydney
Locked Bag 77
Camperdown NSW 1450
Country
Australia
Secondary sponsor category [1] 1516 0
None
Name [1] 1516 0
Nil
Address [1] 1516 0
Country [1] 1516 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3176 0
University of Sydney HREC
Ethics committee address [1] 3176 0
Ethics committee country [1] 3176 0
Australia
Date submitted for ethics approval [1] 3176 0
Approval date [1] 3176 0
Ethics approval number [1] 3176 0
10-2006/9373

Summary
Brief summary
Recent studies by the US Gynecologic Oncology Group have found that patients, who are given chemotherapy directly into the abdominal cavity as well as through a vein, live longer than those who are given chemotherapy through a vein only.

TRIPOD is a study which will determine if it is possible and safe to treat ovarian cancer patients, in Australia and New Zealand with chemotherapy given directly into the abdomen as well as through a vein. This study will enroll at least 35 patients which will take approximately 1 year.

The aim of the study is to determine if it is possible to treat women with ovarian cancer with chemotherapy, some of which is given directly into the abdomen as well as into the vein. It will also determine how safe it is, what side-effects it causes and how it affects quality of life.
Trial website
Trial related presentations / publications
'Feasibility, acceptability and preferences for intraperitoneal chemotherapy with paclitaxel and cisplatin after optimal debulking surgery for ovarian and related cancers:
an ANZGOG study' This final manuscript was published in the Journal of Gynecologic Oncology Vol. 24, No. 4:359-366.
Public notes

Contacts
Principal investigator
Name 27416 0
Prof Michael Friedlander
Address 27416 0
ANZGOG Coordinating Centre NHMRC Clinical Trials Centre Locked bag 77 Camperdown NSW 1450
Country 27416 0
Australia
Phone 27416 0
+61 2 9562 5000
Fax 27416 0
Email 27416 0
[email protected]
Contact person for public queries
Name 10671 0
TRIPOD Trial Coordinator
Address 10671 0
ANZGOG Coordinating Centre
NHMRC Clinical Trials Centre
Locked bag 77
Camperdown
NSW 1450
Country 10671 0
Australia
Phone 10671 0
+61 2 9562 5000
Fax 10671 0
+61 2 9562 5094
Email 10671 0
[email protected]
Contact person for scientific queries
Name 1599 0
TRIPOD Trial Coordinator
Address 1599 0
ANZGOG Coordinating Centre
NHMRC Clinical Trials Centre
Locked bag 77
Camperdown
NSW 1450
Country 1599 0
Australia
Phone 1599 0
+61 2 9562 5000
Fax 1599 0
+61 2 9562 5094
Email 1599 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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