Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000145303
Ethics application status
Approved
Date submitted
10/05/2016
Date registered
27/01/2017
Date last updated
19/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to investigate the safety of a permanent indwelling catheter for the drainage of malignant ascites in patients experiencing gynecological, gastrointestinal and breast cancers, versus intermittent serial paracentesis.
Scientific title
The MORCA study: A study to investigate the safety of a permanent indwelling catheter for the drainage of malignant ascites in patients experiencing gynecological, gastrointestinal and breast cancers, versus intermittent serial paracentesis.
Secondary ID [1] 289156 0
None
Universal Trial Number (UTN)
U1111-1182-6554
Trial acronym
The MORCA study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malignant ascites 298682 0
Condition category
Condition code
Cancer 298739 298739 0 0
Ovarian and primary peritoneal
Cancer 298740 298740 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 298741 298741 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm A: Temporary placed catheter for recurrent large volume drainage (current best practice)

Arm B: Permanent placed indwelling catheter (Rocket 'Registered Trademark') for intermittent drainage (treatment group).
Operators / Interventional Radiologists restricted to two very experienced radiolkogists are to wear head, face and shoe coverings. All access to the room will be restricted to the team performing the procedure. Patients are to be nil by mouth for 6 hours before the procedure (water with medication allowed). Patients may receive conscious sedation with IV midazolam (1 mg) and IV fentanyl (50 mcg). This will be adjusted as required due to patient discomfort, anxiety and body habitus and previous opiate exposure.

There will be prophylactic pre-procedure antibiotic coverage for skin flora with IV cefazolin 1g will also be administered. An appropriate alternative will be provided for people who have a Cephalosporin allergy.

Radiologic Technique: Sonography will be performed before the surgical scrub to localise of a large pocket of ascites. Lateral location for initial access is preferred to facilitate a medially directed subcutaneous tunnel. This allows the exit site of the catheter to be close to midline, allowing a convenient place for access.

The Rocket Indwelling Abdominal Catheter will be placed as per the product instructions for use. All the equipment needed for placement is included in the Kit. The site is selected and the patient is prepped. The surgical field will be prepared with providone iodine solution. The operative field will then be draped.

The skin of the insertion site and tunnel will be infiltrated with local anaesthetic. A small incision is then made at the insertion site and the tunnel exit site. Under ultrasound guidance the 18g needle will be inserted into the peritoneal cavity and aspiration performed to confirm position. The guide-wire will then be inserted through the needle and the needle removed leaving the guide wire in-situ. The IAC would then be tunnelled (antegrade) using the pre-attached tunnelling device and then drawn through until the cuff is mid-way along the tunnel.

The 16g tear way sheath will be then inserted over the guide wire into the peritoneal cavity. The catheter detached from its tunneller and inserted through the sheath which is then torn away and removed. The catheter will then be withdrawn until the cuff is one centimetre from the outer end of the tunnel. The primary insertion site and the tunnel exit are then closed and the site is dressed. The included drainage bag would then be attached to the catheter and the ascites allowed to drain freely.

Approximately 90 minutes for the pre and post procedure within interventional radiology, with an additional 6 hours post op follow up within oncology acutes.

The catheter will remain in-situ until death, or removed for an adverse event removal, or at patients request.

Weekly visits to patient home will be carried out by the Research Nurse. Abdomen will be assessed for ascites, if present will be drained up to a maxim of 2L.

Weekly visits will include an assessment of the insertion site for infection, drainage problems ie occlusion and leakage from the insertion site. All results will be recorded and tabled in the results on frequency of each problem.
Intervention code [1] 294675 0
Treatment: Devices
Comparator / control treatment
Arm A: Temporary placed catheter for recurrent large volume drainage (current best practice). The patient attends acute oncology and sent for ultrasonography both to confirm the presence of fluid and to identify where the most successful entry point for the drain would be. Once a site is chosen an “X” is marked on the skin using an ink pen. The patient then returns to Acute Oncology for paracentesis. The patient is discharged as soon as drainage is completed.

Patients are contacted weekly to assess their level of discomfort and to determine the best time to come in and have a paracentesis. This is very individual and can range from once a week to once every 30 days.
Control group
Active

Outcomes
Primary outcome [1] 298220 0
The primary objective is to determine the difference in quality of life between the two groups as assessed by the EORTC QLQ-C30 (scores of primary interest). The study will have 80% power and 95% confidence to detect a 20 point difference between the two groups.
Timepoint [1] 298220 0
Difference in score between baseline and at 12 week visit.
Secondary outcome [1] 323556 0
Measure of Ovarian Symptoms and Treatment (MOST) questionnaire.

This questionnaire will be used for all patients.
Timepoint [1] 323556 0
Difference in score between baseline and at 12 week visit.
Secondary outcome [2] 323557 0
Patient Satisfaction with Treatment FACIT-TS-G (Version 1) questionnaire
Timepoint [2] 323557 0
Difference in score between baseline and at 12 week visit.
Secondary outcome [3] 323558 0
Paracentesis-free interval / Drainage-free interval
Timepoint [3] 323558 0
Difference in results between baseline and at 12 week visit. Calculated from Baseline/Random visit to next drainage in days.
Secondary outcome [4] 323559 0
Serious Adverse Events (SAEs) will be recorded as per CTC version 3.0. Severity (CTC grade 1-4) its relationship to the study drug/treatment (suspected/not suspected) and its duration (start and end dates or if continuing at final exam) will be recorded.

An example would be an infection from the indwelling catheter, CTC grade on WCC and if oral or Iv antibiotics are required.

There will be an Independent Monitoring Committee (IMC) for this study. They will be requested to assess the trial safety after 10 patents have been recruited to the study. The study will be terminated if there are three or more SAEs thought to be due to the study treatment OR as directed by the Independent Monitoring Committee at any time
Timepoint [4] 323559 0
Weekly from baseline for 12 weeks and/or 28 days from last study visit.
Secondary outcome [5] 323560 0
Karnofsky Score (KS)
Timepoint [5] 323560 0
Difference in score between baseline and at 12 week visit.
Secondary outcome [6] 323827 0
AEs (adverse events) will be recorded as per CTC version 3.0. Severity (CTC grade 1-4) its relationship to the study drug/treatment (suspected/not suspected) and its duration (start and end dates or if continuing at final exam) and whether it constitutes a serious adverse event (SAE)will be recorded.
Timepoint [6] 323827 0
Weekly from baseline for 12 weeks and/or 28 days from last study visit.
Secondary outcome [7] 323828 0
ECOG PS
Timepoint [7] 323828 0
Difference in score between baseline and at 12 week visit.

Eligibility
Key inclusion criteria
1. Patients greater than or equal to 18 years old
2. Histologically confirmed cancer (Histological or cytological specimens must be collected via surgical biopsy, brushing, washing or core needle aspiration of a defined lesion)
3. Patients should be aware of the diagnosis of cancer and that there are no further systemic anti-cancer treatment options open to them
4. Patients diagnosed with cancer of ovarian (or related), gastrointestinal or breast cancer
5. Patients able to give written informed consent obtained according to local guidelines
6. Fulfils at least Grade 2 or 3 International Ascites Club criteria and are symptomatic. (Grade 2: moderate ascites with moderate symmetrical distension of the abdomen and Grade 3: large or gross ascites with marked abdominal distension). Patients should have greater than or equal to grade 2 ascites.
7. Karnofsky Score greater than or equal to 60 OR ECOG Performance Status 0, 1, 2 or 3
8. Requires two therapeutic paracentesis within the last 30 days and been paracentesis-free for the last seven days.
9. Patients with systolic BP greater than or equal to 100 mmHG or diastolic greater than or equal to 60 mm HG

10. Lab values within the range as defined below, on day of randomisation
Absolute neutrophils count (ANC) greater than or equal to 1.5 x 109/L
Platelets greater than or equal to 100 x 109/L
Haemoglobin greater than or equal to 90 g/dL
INR greater than or equal to 1.3
Serum creatinine less than or equal to 1.5 x ULN
Serum bilirubin ULN and both Aspartate transaminase (AST) and Alanine transaminase less than or equal to 5 x ULN
11. Life expectancy greater than or equal to 3 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient unwilling or unable to comply with the study protocol
2. Patients with a stoma
3. Patients receiving enteral feeding
4. Concurrent severe and / or uncontrolled medical disease (e.g. uncontrolled diabetes)
5. Infection e.g. peritoneal cavity
6.History of liver disease with chronic cirrhosis
7. Planned intravenous, oral or intraperitoneal chemotherapy or immunotherapy and active treatment in the last 21 days.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enclosed treatment assignments will be serially numbered in opaque, sealed envelopes and opened sequentially after the participant’s name and other details have been written on the appropriate envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Performed by Ms Joanna Stewart and Ms Ying Huang (Bio-statistician's University of Auckland).

Block randomisation by using SAS 9.4
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
To investigate the effect of treatment on the outcomes of interest a general linear mixed model will be used to run a random co-efficient analysis with the EORTC QLQ C30 QOL score as the outcome, time, group and time by group interaction as explanatory variables. The slope over time and intercept for each individual will be included as random effects. These items of primary interest are those questions that assess symptoms related to ascites and overall quality of life. They are questions 8-15, 18-19, 29 and 30. That is 12 of the total 30 questions from the EORTC QLQ-C30.

The study will have 80% power and 95% confidence to detect a 20 point difference in the primary items of interest within the EORTC QLQ-C30 between the two groups. This is a large difference and therefore if the study is negative a smaller but still not insignificant difference may still exist. There will be a 58% power to detect a 15 point difference.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Other reasons/comments
Other reasons
Indwelling catheters now starting to be inserted outside the trial at other DHBs and in the private sector.
Date of first participant enrolment
Anticipated
Actual
22/03/2016
Date of last participant enrolment
Anticipated
30/04/2017
Actual
22/02/2017
Date of last data collection
Anticipated
Actual
22/03/2017
Sample size
Target
40
Accrual to date
Final
11
Recruitment outside Australia
Country [1] 7866 0
New Zealand
State/province [1] 7866 0
Auckland

Funding & Sponsors
Funding source category [1] 293544 0
Government body
Name [1] 293544 0
Auckland District Health Board A+ grant
Country [1] 293544 0
New Zealand
Primary sponsor type
Hospital
Name
Auckland City Hospital Cancer and Blood Research
Address
Gillian Vernon
Research Manager
Cancer and Blood Research
Lower Ground Floor, Building 13,
Auckland City Hospital, Auckland, 1023
Post Address: Private Bag 92024, Auckland, 1142
Country
New Zealand
Secondary sponsor category [1] 292358 0
None
Name [1] 292358 0
Address [1] 292358 0
Country [1] 292358 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294984 0
Health and Disability Ethics Committees
Ethics committee address [1] 294984 0
Ministry of Health
Freyberg Building
20 Aitken Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 294984 0
New Zealand
Date submitted for ethics approval [1] 294984 0
27/10/2015
Approval date [1] 294984 0
18/11/2015
Ethics approval number [1] 294984 0
15/NTA/185

Summary
Brief summary
A randomised study of a temporary placed catheter for serial intermittent use versus a permanent placed indwelling catheter (Rocket 'Registered Trademark') for continuous drainage of malignant ascites in cancer patients. This study will investigate the acceptability and safety of an indwelling catheter for patients with cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65678 0
Dr Celia Palmer
Address 65678 0
Department of Palliative Care
Auckland City Hospital
Private Bag 92024
Auckland Mail Centre
Auckland 1142
Country 65678 0
New Zealand
Phone 65678 0
+6421631484
Fax 65678 0
Email 65678 0
celiap@hwa.org.nz
Contact person for public queries
Name 65679 0
Celia Palmer
Address 65679 0
Department of Palliative Care
Auckland City Hospital
Private Bag 92024
Auckland Mail Centre
Auckland 1142
Country 65679 0
New Zealand
Phone 65679 0
+6421631484
Fax 65679 0
Email 65679 0
celiap@hwa.org.nz
Contact person for scientific queries
Name 65680 0
Celia Palmer
Address 65680 0
Department of Palliative Care
Auckland City Hospital
Private Bag 92024
Auckland Mail Centre
Auckland 1142
Country 65680 0
New Zealand
Phone 65680 0
+6421631484
Fax 65680 0
Email 65680 0
celiap@hwa.org.nz

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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