Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000865314
Ethics application status
Approved
Date submitted
7/06/2017
Date registered
13/06/2017
Date last updated
22/08/2022
Date data sharing statement initially provided
23/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The 10Ten Study: Quality of Life after Surgery for Recurrent Rectal Cancer.
Scientific title
The 10Ten Study: Quality of Life after Surgery for Recurrent Rectal Cancer.
Secondary ID [1] 292148 0
Nil
Universal Trial Number (UTN)
U1111-1197-6196
Trial acronym
10Ten
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent Rectal Cancer 303580 0
Condition category
Condition code
Cancer 302987 302987 0 0
Bowel - Anal
Cancer 302990 302990 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Surgical intervention. Half the participants will have surgical intervention for their recurrent rectal cancer. These patients will be followed up for five years or until death. On top of the surgery, they may receive chemotherapy and/or radiation. The decision to receive surgical intervention is made by the patient and their treating doctor, and is not a result of enrolling in this study (i.e. enrolment in this study results in no change to care because this is not a randomized controlled trial).
Intervention code [1] 298291 0
Diagnosis / Prognosis
Comparator / control treatment
Non-surgical intervention. Half the participants will not have surgical intervention for their recurrent rectal cancer. These patients will be followed up for five years or until death. On top of not having surgery, they may receive chemotherapy and/or radiation. The decision to receive non-surgical treatment is made by the patient and their treating doctor, and is not a result of enrolling in this study (i.e. enrolment in this study results in no change to care because this is not a randomized controlled trial).
Control group
Active

Outcomes
Primary outcome [1] 302363 0
Quality adjusted life years will be measured using the EQ-5D-5L questionniare. This questionnaire briefly measures 5 domains of health: mobility, self-care, usual activities, pain and discomfort, and anxiety/depression. There are five answers to choose from for each question: no problems, slight problems, moderate problems, severe problems, and unable to/extreme problems. If all five questions are answered as “no problems” the quality component will be a perfect one whereas if all questions are answered as “unable to/extreme problems” the quality component will be below zero. In addition to the 5 questions, there is a visual analogue scale (ranging from 0 = the worst health you can imagine to 100 = the best health you can imagine) which people can mark with an “X” where they think their health status is.
Timepoint [1] 302363 0
Follow up is for 5 years post diagnosis of recurrent rectal cancer. The timepoints are baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months, and 60 months.
Secondary outcome [1] 335736 0
Quality of Life is measured using Short Form 12 which contains twelve questions and produces scores for physical and mental components.
Timepoint [1] 335736 0
Follow up is for 5 years post diagnosis of recurrent rectal cancer. The timepoints are baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months, and 60 months.
Secondary outcome [2] 335737 0
Survival over 5 years will be measured. Cancer specific and general survival will be examined.
Timepoint [2] 335737 0
Follow up is for 5 years post diagnosis of recurrent rectal cancer. The timepoints are baseline, 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months, and 60 months.

Eligibility
Key inclusion criteria
Those included for this study will:
• have an isolated locally recurrent adenocarcinoma of the rectum or recto-sigmoid being considered for radical resection with or without perioperative chemoradiation.
• be aged 18 years or older
• be able to consent to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those excluded will:
• not have an adenocarcinoma
• have primary (not recurrent) cancers
• have non-resectable metastatic disease.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Case control
Timing
Prospective
Statistical methods / analysis
The data will be managed by a centralised electronic database in Christchurch, New Zealand. Patients will have a unique identifying code so as to keep them de-identified and anonymous to outside observers. Individual centre data will be available to that centre’s PI, until the close of the study when all data from all centres will be available to all PI’s.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
16/06/2016
Date of last participant enrolment
Anticipated
31/12/2021
Actual
15/09/2021
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
220
Accrual to date
Final
111
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 8310 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [2] 8311 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 8312 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 16373 0
3000 - Melbourne
Recruitment postcode(s) [2] 16374 0
2050 - Camperdown
Recruitment postcode(s) [3] 16375 0
4029 - Herston
Recruitment outside Australia
Country [1] 8956 0
New Zealand
State/province [1] 8956 0
Canterbury and Auckland

Funding & Sponsors
Funding source category [1] 296680 0
University
Name [1] 296680 0
University of Otago, Christchurch
Country [1] 296680 0
New Zealand
Primary sponsor type
University
Name
University of Otago, Christchurch
Address
Department of Surgery
University of Otago, Christchurch
2 Riccarton Ave
Christchurch 8011
New Zealand
Country
New Zealand
Secondary sponsor category [1] 295640 0
None
Name [1] 295640 0
Address [1] 295640 0
Country [1] 295640 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297909 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 297909 0
Ethics committee country [1] 297909 0
New Zealand
Date submitted for ethics approval [1] 297909 0
14/04/2016
Approval date [1] 297909 0
02/06/2016
Ethics approval number [1] 297909 0
H16/061

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75430 0
Prof Frank Frizelle
Address 75430 0
Department of Surgery
University of Otago, Christchurch
2 Riccarton Ave
Christchurch 8011
New Zealand
Country 75430 0
New Zealand
Phone 75430 0
+6421722198
Fax 75430 0
Email 75430 0
frank.frizelle@cdhb.health.nz
Contact person for public queries
Name 75431 0
Andrew McCombie
Address 75431 0
Department of Surgery
University of Otago, Christchurch
2 Riccarton Ave
Christchurch 8011
New Zealand
Country 75431 0
New Zealand
Phone 75431 0
+64272626111
Fax 75431 0
Email 75431 0
mccombieandrew@hotmail.com
Contact person for scientific queries
Name 75432 0
Andrew McCombie
Address 75432 0
Department of Surgery
University of Otago, Christchurch
2 Riccarton Ave
Christchurch 8011
New Zealand
Country 75432 0
New Zealand
Phone 75432 0
+64272626111
Fax 75432 0
Email 75432 0
mccombieandrew@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13230Study protocol    373093-(Uploaded-05-11-2020-08-40-40)-Study-related document.docx
13231Informed consent form    373093-(Uploaded-21-04-2020-08-25-09)-Study-related document.docx
13232Ethical approval    373093-(Uploaded-21-04-2020-08-26-38)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.