Clinical Trial Details

The 10Ten Study: Quality of Life after Surgery for Recurrent Rectal Cancer.

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Trial Information

Broad Health Condition Cancer
Cancer

Specific Health ConditionBowel - Anal
Bowel - Back passage (rectum) or large bowel (colon)

Trial Focus

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,VIC

Hospital
Peter MacCallum Cancer Centre - Melbourne
Royal Prince Alfred Hospital - Camperdown
Royal Brisbane & Womens Hospital - Herston


Postcode
3000 - Melbourne
2050 - Camperdown
4029 - Herston


Trial location outside Australia
New ZealandCanterbury and Auckland

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Trial summary

This study aims to compare the Quality of life and Quality adjusted life years of surgical versus non-surgical Recurrent Rectal Cancer patients.

Who is it for?

You may be eligible to join this study if you are aged 18 years or above and have an isolated locally recurrent adenocarcinoma of the rectum or recto-sigmoid being considered for radical resection with or without perioperative chemoradiation.

Study details
If you choose to take part in this research, you will be asked to allow the investigators to access your disease related health information and will also be asked to complete questionnaires numerous times over five years. You will be asked about your demographics and quality of life at baseline; you will be asked about your quality of life at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months, and 60 months. Conversely, if you choose not to take part in the study, the care provided to you will not be changed or prejudiced due to this decision; this is a purely voluntary study. There is no reimbursement for time or expenses.


This study will provide important information about both the quality and quantity of the lifespan after diagnosis of Recurrent Rectal Cancer band thus could potentially assist in future treatment decisions.
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 age18 Years

GenderBoth 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.
Contact details and further information

Sponsor Primary Sponsor Type: University
Primary Sponsor Name: University of Otago, Christchurch
Primary Sponsor Address: Department of Surgery University of Otago, Christchurch 2 Riccarton Ave Christchurch 8011 New Zealand
Primary Sponsor Country: New Zealand

Trial IDACTRN12617000865314

UTNU1111-1197-6196

Contact person for information and recruitmentDr
Andrew McCombie
Department of Surgery University of Otago, Christchurch 2 Riccarton Ave Christchurch 8011 New Zealand
+64272626111

Further information iconmccombieandrew@hotmail.com
New Zealand