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Trial registered on ANZCTR


Registration number
ACTRN12618000372280
Ethics application status
Approved
Date submitted
12/02/2018
Date registered
12/03/2018
Date last updated
15/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Relook Laparoscopy for Peritoneal Surface Disease (ReLaPSeD) Trial
A prospective randomised controlled trial comparing relook laparoscopy vs. standard follow-up for early detection and treatment of patients at high risk for peritoneal metastases after resection of colorectal cancer
Scientific title
Relook Laparoscopy for Peritoneal Surface Disease (ReLaPSeD) Trial
A prospective randomised controlled trial comparing relook laparoscopy vs. standard follow-up for early detection and treatment of patients at high risk for peritoneal metastases after resection of colorectal cancer
Secondary ID [1] 293746 0
None
Universal Trial Number (UTN)
Trial acronym
ReLaPSeD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer with high risk features for peritoneal metastases 306543 0
Condition category
Condition code
Cancer 305643 305643 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Surgery 305701 305701 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnostic laparoscopy refers to examination of the abdominal cavity through minimally-invasive ("key-hole") surgery. It takes approximately 45 - 60 minutes and will be performed by a specialist colorectal surgeon.

Patients randomised to the intervention group will undergo relook diagnostic laparoscopy at 9- 12 months post surgery (in addition to standard follow up tests, including clinical review, tumour markers and regular CT scans).
Intervention code [1] 300292 0
Treatment: Surgery
Intervention code [2] 300330 0
Diagnosis / Prognosis
Intervention code [3] 300331 0
Early detection / Screening
Comparator / control treatment
Patients randomised to the control group will undergo standard follow up tests for cancer relapse following surgery (i.e. without diagnostic laparoscopy). Standard follow up tests include 3 monthly clinical review, 3 monthly tumour markers (CEA, CA 19.9 and CA 125) and 12 monthly CT scan of the chest, abdomen and pelvis.
Control group
Active

Outcomes
Primary outcome [1] 304756 0
To report and compare the 3-year overall survival in patients managed with relook laparoscopy vs. standard follow-up following curative resection for high risk colorectal cancer
Timepoint [1] 304756 0
3 years post-randomisation
Secondary outcome [1] 343010 0
To report the 3 year disease-free survival rate in both groups (where disease recurrence is defined as the appearance of local disease or any distant metastases). This will be assessed as follows:
- For patients in the standard follow up (control) group or patients with a negative relook laparoscopy (no macroscopic disease): 3 monthly clinical review, 3 monthly tumour markers (CEA, CA 19.9 and CA 125) and 12 monthly CT scan of the chest, abdomen and pelvis.
- For patients in the relook laparoscopy (intervention) group with peritoneal disease who undergo cytoreductive surgery and intraperitoneal chemotherapy: 3 monthly clinical review, 3 monthly tumour markers (CEA, CA 19.9 and CA 125) and 6 monthly CT chest/abdomen/pelvis for 2 years. After 2 years, clinical review and tumour markers will be assessed every 6 months and CT scan performed annually.
Timepoint [1] 343010 0
3 years post-randomisation
Secondary outcome [2] 343203 0
To determine the quality of life of patients in both treatment groups using the EuroQol five dimensions questionnaire (EQ5D) and the work and health care utilisation and patient experience questionnaire (National set of core, common patient experience questions – for overnight-admitted patients – Australian Commission on Safety and Quality in Health Care) (composite outcome)
Timepoint [2] 343203 0
3 years post-randomisation
Secondary outcome [3] 343204 0
To assess the feasibility and safety (including complication rates) of diagnostic laparoscopy in this group of patients.
This is a composite endpoint and will be assessed by participant accrual for the trial as well as early, in hospital and late (within 30 days) morbidity and mortality. Morbidity will be documented and reported using the Clavien-Dindo classification.
Potential complications include:
• Infection
• Ileus
• Urinary retention/dysfunction
• Peri-operative haemorrhage
• Damage to abdominopelvic organs or neurovascular structures
• General medical complications
• Anaesthetic complications
Timepoint [3] 343204 0
30 days post diagnostic laparoscopy
Secondary outcome [4] 343205 0
To assess the costs associated with the addition of a diagnostic laparoscopy procedure and its cost-effectiveness in the management of patients with PM
Timepoint [4] 343205 0
3 years post-randomisation.
EQ5D and AQOL-8D questionnaires will provide the utility scores needed to calculate QALYs.
Secondary outcome [5] 343207 0
To report the rate of microscopic peritoneal disease (i.e. positive cytology from peritoneal washings) in patients without macroscopic PM at laparoscopy (i.e. negative laparoscopy)
Timepoint [5] 343207 0
One week post surgery

Eligibility
Key inclusion criteria
Resected colorectal adenocarcinoma (confirmed on histopathology) with complete oncological excision (i.e. clear resection margins),

AND, one or more of the following high-risk features:

i. Synchronous peritoneal or ovarian metastases that were resected completely at time of surgery
ii. Perforated tumour (including iatrogenic perforation)
iii. T4 tumour
iv. Mucinous T3 tumour
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Metastatic disease on preoperative staging
ii. Recurrent disease on staging after adjuvant chemotherapy
iii. Age < 18 or > 80
iv. ASA >3, ECOG >2
v. Tumour histology not colorectal adenocarcinoma
vi. Major uncontrolled medical comorbidity
vii. Medical conditions causing inability to give informed consent or comply with the study protocol

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)
After recruitment of a patient at a study site, the sites will fax or email recruitment data to the central coordinating body, the Surgical Outcomes Research Centre. After verification of patient eligibility, allocation to either treatment arm is performed by an electronic randomisation system which generates patient study ID and treatment arm.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
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
Overall survival will be estimated using the Kaplan-Meier product limit method, with median survival estimates presented alongside 95% confidence intervals (95% CI). Differences between groups (second look laparoscopy and usual care control) will be assessed using the log-rank test. Categorical data will be presented as frequencies (percentage), and continuous data presented as mean and standard deviation (SD) for normally distributed data, or median (range) for skewed data. Statistical significance will be set at p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 9999 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 10000 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 18839 0
2050 - Camperdown
Recruitment postcode(s) [2] 18840 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 298360 0
Other
Name [1] 298360 0
Surgical Outcomes Research Centre
Address [1] 298360 0
Surgical Outcome Research Centre, Royal Prince Alfred Hospital
PO Box M157
Camperdown NSW 2050
Country [1] 298360 0
Australia
Primary sponsor type
Other
Name
Surgical Outcome Research Centre
Address
Surgical Outcome Research Centre, Royal Prince Alfred Hospital
PO Box M157
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 297484 0
None
Name [1] 297484 0
Address [1] 297484 0
Country [1] 297484 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299353 0
Sydney Local Health District Human Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 299353 0
Research Ethics and Governance Office (REGO)
RPAH Medical Centre
Suite 210A, 100 Carillon Avenue
NEWTOWN NSW 2042
Ethics committee country [1] 299353 0
Australia
Date submitted for ethics approval [1] 299353 0
27/11/2017
Approval date [1] 299353 0
07/02/2018
Ethics approval number [1] 299353 0
X17-0424 & HREC/17/RPAH/639

Summary
Brief summary
This study has been designed to compare relook laparoscopy versus standard follow up for early detection and treatment of patients at high risk for metastases after resection of colorectal cancer.

Who is it for?
You may be eligible for this study if you are aged between 18 and 80 years, have been diagnosed with primary colorectal cancer for which you have undergone colorectal resection, and are at high risk of the cancer spreading within the abdomen (peritoneal metastases).

Study details
Participants will be randomly allocated (by chance) to undergo either a relook laparoscopy 9-12 months after initial colorectal cancer surgery in addition to standard follow-up or continue with standard follow-up only. Diagnostic laparoscopy refers to examination of the abdominal cavity through minimally-invasive ("key-hole") surgery. Standard follow up tests include regular blood tests for levels of tumour markers (every three months) and regular CT scans (yearly).

Participants will then be followed up over three years to assess disease status (i.e. remission or relapse) and to complete a series of questionnaires to determine quality of life.

It is hoped that this research will help determine whether a relook laparoscopy is a valid and effective way of increasing survival rates in patients with high risk colorectal cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80158 0
A/Prof Cherry Koh
Address 80158 0
Surgical Outcomes Research Centre, Royal Prince Alfred Hospital
PO Box M157
Camperdown NSW 2050
Country 80158 0
Australia
Phone 80158 0
+61 2 9515 3200
Fax 80158 0
+61 2 9515 3222
Email 80158 0
cherry_koh@hotmail.com
Contact person for public queries
Name 80159 0
Dr Kilian Brown
Address 80159 0
Surgical Outcomes Research Centre, Royal Prince Alfred Hospital
PO Box M157
Camperdown NSW 2050
Country 80159 0
Australia
Phone 80159 0
+61 2 9515 3200
Fax 80159 0
+61 2 9515 3222
Email 80159 0
kilian.brown@sydney.edu.au
Contact person for scientific queries
Name 80160 0
Dr Kilian Brown
Address 80160 0
Surgical Outcomes Research Centre, Royal Prince Alfred Hospital
PO Box M157
Camperdown NSW 2050
Country 80160 0
Australia
Phone 80160 0
+61 2 9515 3200
Fax 80160 0
+61 2 9515 3222
Email 80160 0
kilian.brown@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
No Results