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Assessment of Fitness After Neoadjuvant Chemoradiotherapy in Rectal Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Michelle Mossa, Aintree University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01334593
First received: April 11, 2011
Last updated: December 29, 2012
Last verified: December 2012
  Purpose

Neoadjuvant chemoradiotherapy (NACRT) prior to surgery for lower gastrointestinal (colon and rectal) cancer is associated with improved survival, but also adversely affects physical fitness, potentially rendering patients unfit for major surgery or increasing the risk of adverse outcome (death and serious complications) after major surgery. The investigators aim to obtain pilot data showing that neoadjuvant chemoradiotherapy (NACRT)reduces objectively measured exercise capacity (fitness).


Condition
Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Neoadjuvant Chemoradiotherapy on Exercise Capacity in Colrectal Cancer Patients

Resource links provided by NLM:


Further study details as provided by Aintree University Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Measurement of Cardio Pulmonary exercise test related parameters (VO2 at AT) pre and post neoadjuvant chemoradiotherapy in rectal cancer patients. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Exercise capacity (fitness) before and after NACRT will be assessed using CPET.We have pilot data on an upper gastrointestinal cancer cohort that shows that neoadjuvant chemotherapy alone results in lower levels of fitness (mean fall VO2@LT of 2.19ml/kg/min), which relates to survival before stomach and oesophageal surgery in a group of patients in Liverpool. These data also suggest that the insult of chemotherapy and surgery increases mortality


Enrollment: 25
Study Start Date: August 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Rectal Cancer

Detailed Description:

Purpose: To evaluate the effects of chemoradiotherapy on pre−operative fitness of patients prior to major colorectal cancer surgery.

Design: Patients will act as their own case−control.

Patients will be consented at the earliest available opportunity following the decision that they have surgically treatable disease and they consent to pre−operative NACRT. Consent for the study will be gained as an outpatient. At "visit 1" patients will undergo CPET, as is our current standard practice, prior to commencing neoadjuvant chemoradiotherapy. As part of the assessment, they will have pulmonary function testing (static lung volumes, lung diffusing capacity). They will then undergo 6 weeks of long course NACRT, as is standard current practice at our institution. At "visit 2", approximately four to six weeks following chemoradiotherapy another CPET test will be repeated. This is also current standard practice at our institution. Data from visit 1 and visit 2 will be compared in a paired manner. A statistician will be consulted to assess the degree of normality of the data, the statistical tests to use, and for power calculations. At no point will any treatments be postponed or changed solely for the purposes of collecting data for the research.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Colorectal cancer is the third commonest cause of cancer related death (after breast and lung cancer) in the United Kingdom and the second commonest in non smokers. Around 100 new cases of colorectal cancer are diagnosed each day in the UK. In 2002 there were 34,889 new cases of colorectal cancer diagnosed in the United Kingdom, and approximately 17,000 deaths (CRUK 2006). Almost three quarters of bowel cancer cases occur in people aged 65 and over. Within England, mortality rates are generally higher in the north of the country.

Criteria

Inclusion Criteria:

  • All patients listed to undergo neoadjuvant chemoradiotherapy for downstaging of colorectal cancer, with a view to undergo elective colorectal surgery at Aintree University Hospitals.

Exclusion Criteria:

  • Unable to consent.
  • Under 18 years of age.
  • Significant ischaemic changes of >1.5mm symptomatic and > 2mm asymptomatic observed on routine cardiopulmonary exercise test.
  • Any other absolute contraindications to CPET based on the ATS guidelines.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01334593

Locations
United Kingdom
Aintree University Hospitals
Liverpool, Merseyside, United Kingdom, L7 8XP
Sponsors and Collaborators
Michelle Mossa
Investigators
Principal Investigator: Malcolm A West Aintree University Hospitals NHS Foundation Trust, Liverpool, UK
  More Information

No publications provided

Responsible Party: Michelle Mossa, Deputy Research and Development Director, Aintree University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01334593     History of Changes
Other Study ID Numbers: 11/H1002/12b
Study First Received: April 11, 2011
Last Updated: December 29, 2012
Health Authority: United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on November 24, 2014