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Trial registered on ANZCTR


Registration number
ACTRN12619000207112
Ethics application status
Approved
Date submitted
23/01/2019
Date registered
13/02/2019
Date last updated
5/06/2019
Date data sharing statement initially provided
13/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Longitudinal Cohort Study of ‘Watch and Wait’ in Complete Clinical Responders after Chemo-radiotherapy for Localised Rectal Cancer
Scientific title
A Longitudinal Cohort Study of ‘Watch and Wait’ in Complete Clinical Responders after Chemo-radiotherapy for Localised Rectal Cancer
Secondary ID [1] 297185 0
Nil known
Universal Trial Number (UTN)
Trial acronym
REctal cancer Non-Operative (RENO)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rectal Cancer 311238 0
Condition category
Condition code
Cancer 309860 309860 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will complete chemoradiation and then based on response (complete response or other) they will be allocated to one of the two study cohorts; follow up with MRI scans (complete responders -considered the intervention arm) or surgery (other).
The surgery is considered the standard arm.
For patients whom are complete responders and go onto the MRI arm, they will not receive surgery. Instead they will be followed up with clinical assessments and sigmoidoscopy, every 3 months for two years; CT scan at 6, 12 and 24 months; MRI and blood tests every 3 months in the first year then 6 monthly in the second year.
Intervention code [1] 313444 0
Treatment: Other
Comparator / control treatment
Patients will complete chemoradiation and then based on response (complete response or other) they will be allocated to one of the two study cohorts; follow up with MRI scans (complete responders) or surgery (other). Surgery is the control and the standard pathway for patients. [Clinical practice guidelines for the prevention, early detection and management of colorectal cancer” developed by Cancer Council Australia,
These guidelines are in line with the available evidence and in keeping with recommendations from international guidelines (ESMO and NCCN)]

Control group
Active

Outcomes
Primary outcome [1] 318804 0
1. Determine the efficacy of the ‘Watch and Wait’ strategy, by measuring the following endpoints:
a. Co-Primary endpoint-1: The ‘two-year local failure rate’ (in the ‘Watch and Wait’ arm) defined as local recurrence that cannot be resected with clear margins - determined by patients through MRI, CT scan and surgical review.
Timepoint [1] 318804 0
This will be assessed up to two years following chemoradiation using the following

Sigmoidoscopy, every 3 months for two years
CT scan at 6, 12 and 24 months
MRI & blood tests every 3 months in the first year then 6 monthly in the second year
Primary outcome [2] 318969 0
b. Co-Primary endpoint-2: The rate of rectal preservation (in the ‘Watch and Wait’ arm) measured by number of patients not requiring surgery
Timepoint [2] 318969 0
Two years post end of patients chemoradiation treatment
Secondary outcome [1] 366102 0
1. Determine the safety of the ‘Watch & Wait’ strategy by measuring the following endpoint (in the watch and wait arm): (composite)
a. The ‘two-year local recurrence rate’
b. The ‘two-year distant metastasis rate’
c. The overall survival
d. The ‘incurable disease-free survival rate’ (recurrent cancer that cannot be surgically excised with the intention of achieving a cure)
These will be assessed through the use of MRI's, CT scans, sigmoidoscopy and clinical examinations.
Timepoint [1] 366102 0
This will be assessed up to two years following chemoradiation using the following

Sigmoidoscopy, every 3 months for two years
CT scan at 6, 12 and 24 months
MRI & blood tests every 3 months in the first year then 6 monthly in the second year
Clinic visit every 3 months
Secondary outcome [2] 366104 0
To investigate Patient reported Outcome Measures -Quality of Life

Quality of Life is defined as the general well-being of the individual; this outcome is measured using the EORTC QLQ-C30 questionnaire which is a validated questionnaire developed to assess the quality of life of cancer patients. The EORTC QLQ-CR-29 will also be used; this is a validated questionnaire developed to assess the quality of life of patients with a history of colorectal cancer and is used in addition to the EORTC QLQ-C30 questionnaire.
Timepoint [2] 366104 0
Completed in all patients at screening, 6-8 weeks post chemoradiotherapy, 12 months and 24 months post chemoradiotherapy.
Secondary outcome [3] 366873 0
To investigate Patient reported Outcome Measures - Health Related Quality of Life.

Health-related quality of life is a multi-dimensional concept that includes domains related to physical, mental, emotional and social functioning. This outcome will be measured using a validated questionnaire: the EQ-5D-5L questionnaire
Timepoint [3] 366873 0
completed in all patients at screening, 6-8 weeks post chemoradiotherapy, 12 months and 24 months post chemoradiotherapy.
Secondary outcome [4] 366874 0
To investigate Patient reported Outcome Measures - Fear of Cancer Recurrence

Fear of Cancer Recurrence (FCR) defined as feeling anxious about the cancer coming back and is measured by Fear of Cancer Recurrence Inventory (FCRI SF). To interpret the FCR results and to measure response efficacy we will use a modified Response Efficacy Scale specifically designed for this study.
Timepoint [4] 366874 0
All patients will complete the Fear of Cancer Recurrence Inventory at screening, 6-8 weeks post chemoradiotherapy, 12 months and 24 months post chemoradiotherapy.
The Response efficacy questionnaire will be implemented at 12 and 24 months post chemoradiotherapy.
Secondary outcome [5] 366875 0
To investigate Patient reported Outcome Measures - survivorship and supportive care needs

Ongoing supportive care needs across the survivorship continuum will be measured using Cancer Survivors unmet needs (CaSUN) questionnaire
Timepoint [5] 366875 0
This will be measured in all patients at 12 months and 24 months post chemoradiotherapy.
Secondary outcome [6] 366876 0
To investigate Patient reported Outcome Measures - Bowel Related Quality of Life.

This outcome encompasses multiple aspects of bowel function and will be measured using the MSKCC Bowel Function Questionnaire and LARS score.
Timepoint [6] 366876 0
All patients will complete the Fear of Cancer Recurrence Inventory at screening, 6-8 weeks post chemoradiotherapy, 12 months and 24 months post chemoradiotherapy.

Eligibility
Key inclusion criteria
1. Age 18 years or older
2. Biopsy proven locally advanced rectal adenocarcinoma:
o Locally advanced disease defined as: T3 AND N0-2, T1-2 AND N1-2 [Based on AJCC UICC 2017]
3. Subject to undergo Long Course Neoadjuvant Chemo-Radiotherapy based on a multidisciplinary meeting recommendation
4. Considered suitable for long course pelvic radiation therapy
5. Considered suitable for surgery
6. Considered suitable for MRI
7. Willing and able to comply with all study requirements, including treatment and follow up assessments
8. Signed, written informed consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Presence of metastatic disease (M1)
2. T4 disease based on AJCC 2017
3. Local recurrence of previously treated rectal cancer
4. Previous pelvic radiotherapy
5. Contraindication to fluoropyrimidine chemotherapy
6. History of another malignancy:
a. Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible. Patients with a history of other malignancies are eligible if they have been continuously disease free for at least 5 years after definitive primary treatment.
7. Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the chemoradiation with reasonable safety
8. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol including chemoradiation and/or follow-up schedule.

Study design
Purpose of the study
Educational / counselling / training
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
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)
SA

Funding & Sponsors
Funding source category [1] 301741 0
Other Collaborative groups
Name [1] 301741 0
Australian Gastro-intestinal Trials Group
Address [1] 301741 0
GI Cancer Institute @Lifehouse
Level 6, 119-143 Missenden Rd
Camperdown NSW 2050
Country [1] 301741 0
Australia
Primary sponsor type
Government body
Name
Southern Adelaide Local Health Network Inc
Address
Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042
Country
Australia
Secondary sponsor category [1] 301482 0
None
Name [1] 301482 0
Address [1] 301482 0
Country [1] 301482 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302461 0
Southern Adelaide Clinical Human Research Ethics
Ethics committee address [1] 302461 0
1 Flinders Drive
Bedford park
SA 5042
Ethics committee country [1] 302461 0
Australia
Date submitted for ethics approval [1] 302461 0
Approval date [1] 302461 0
09/10/2018
Ethics approval number [1] 302461 0

Summary
Brief summary
The purpose of this study is to determine the effectiveness of a ‘wait and watch’ strategy in patients with rectal cancer who have completed chemoradiotherapy.

Who is it for?
You may be eligible for this study if you are an adult who has been diagnosed with advanced rectal cancer and will be undergoing chemoradiotherapy.

Study details
After chemoradiotherapy you will be reviewed for any evidence of cancer, through physical exams, imaging and sigmoidoscopy. If there is evidence of cancer you will have surgery to remove this cancer. If there is no evidence of cancer you will not have surgery but instead be followed up at set time points over 2 years, having further imaging, physical exams blood tests and sigmoidoscopy's.

it is hoped that this research will provide support for the pathway of not conducting surgery on patients who have no evidence of cancer after their chemoradiotherapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90298 0
Prof Chris Karapetis
Address 90298 0
Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042
Country 90298 0
Australia
Phone 90298 0
+61 8 82046151
Fax 90298 0
Email 90298 0
chris.karapetis@sa.gov.au
Contact person for public queries
Name 90299 0
Miss Dania Ruminski-Smith
Address 90299 0
Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042
Country 90299 0
Australia
Phone 90299 0
+61 8 8 2047009
Fax 90299 0
Email 90299 0
dania.ruminski-smith@sa.gov.au
Contact person for scientific queries
Name 90300 0
Miss Dania Ruminski-Smith
Address 90300 0
Flinders Medical Centre
Flinders Drive
Bedford Park
SA 5042
Country 90300 0
Australia
Phone 90300 0
+61 8 8 2047009
Fax 90300 0
Email 90300 0
dania.ruminski-smith@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not in the ethical submission, plan and approval
What supporting documents are/will be available?
No other documents available
Summary results
No Results