CancerNCT01334593
Assessment of Fitness After Neoadjuvant Chemoradiotherapy in Rectal Cancer Patients
An observational study of Cancer, run by Michelle Mossa at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2011to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All patients listed to undergo neoadjuvant chemoradiotherapy for downstaging of colorectal cancer, with a view to undergo elective colorectal surgery at Aintree University Hospitals.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Aintree University Hospitals
Liverpool, Merseyside, L7 8XP
About this study
Official title: The Effect of Neoadjuvant Chemoradiotherapy on Exercise Capacity in Colrectal Cancer Patients
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).
Read the 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.
- Conditions
- Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rectal Cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Cardio Pulmonary exercise test related parameters (VO2 at AT) pre and post neoadjuvant chemoradiotherapy in rectal cancer patients.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2011 (estimated)
- Study startAug 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michelle Mossa
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Michelle Mossa, Liverpool University Hospitals NHS Foundation Trust
- Investigators
- Malcolm A West, Principal investigator, Aintree University Hospitals NHS Foundation Trust, Liverpool, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01334593
- Sponsor's protocol ID
- 11/H1002/12b
- Status last verified
- Dec 2012
- First submitted
- 11 Apr 2011
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
West MA, Loughney L, Barben CP, Sripadam R, Kemp GJ, Grocott MP, Jack S. The effects of neoadjuvant chemoradiotherapy on physical fitness and morbidity in rectal cancer surgery patients. Eur J Surg Oncol. 2014 Nov;40(11):1421-8. doi: 10.1016/j.ejso.2014.03.021. Epub 2014 Apr 12.
PubMed 24784775
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neoadjuvant Chemoradiotherapy on Exercise Capacity in Colrectal Cancer Patients
- ClinicalTrials.gov ID
- NCT01334593
- Acronym / sponsor ID
- 11/H1002/12b
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Michelle MossaOther government
- Study start
- Aug 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 13 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rectal Cancer | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients listed to undergo neoadjuvant chemoradiotherapy for downstaging of colorectal cancer, with a view to undergo elective colorectal surgery at Aintree University Hospitals.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of Cardio Pulmonary exercise test related parameters (VO2 at AT) pre and post neoadjuvant chemoradiotherapy in rectal cancer patients.
Time frame: 2 years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
- Derived from this study: PubMed 24784775West MA, Loughney L, Barben CP, Sripadam R, Kemp GJ, Grocott MP, Jack S. The effects of neoadjuvant chemoradiotherapy on physical fitness and morbidity in rectal cancer surgery patients. Eur J Surg Oncol. 2014 Nov;40(11):1421-8. doi: 10.1016/j.ejso.2014.03.021. Epub 2014 Apr 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malcolm A West principal investigator
Aintree University Hospitals NHS Foundation Trust, Liverpool, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Michelle Mossa at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Cardio Pulmonary exercise test related parameters (VO2 at AT) pre and post neoadjuvant chemoradiotherapy in rectal cancer patients. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01334593, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2013.