Adenocarcinoma of the RectumPhase 2NCT01037049
Optimum Timing for Surgery After Pre-operative Radiotherapy 6 vs 12 Weeks
A Phase 2 study testing Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy in people with Adenocarcinoma of the Rectum and Adenocarcinoma, run by Royal Marsden NHS Foundation Trust at 23 sites in 4 countries.
Trial summary
The aim of this study is to determine whether greater rectal cancer downstaging and regression occurs when surgery is delayed to 12 weeks after completion of radiotherapy/chemotherapy compared to 6 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenocarcinoma of the Rectum, Adenocarcinoma, Adenocarcinoma, Mucinous
- What is being tested?
- Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 23 sitesin 4 countries
- Study dates
- 16 Oct 2009to 8 Dec 2019
- Phase
- Phase 2
- 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
Who may be able to join
- Aged > 18
- Informed written consent
- Histological confirmation of adenocarcinoma of rectum
- Undergoing pre-operative radiotherapy/ chemotherapy
- Completion of pre-operative treatment
Who cannot join
- Aged < 18
- Absence of pre-operative RT/CT
- Medical/ psychiatric conditions that compromise the patients ability to give informed consent
- Contra-indications to MRI, i.e. hip prothesis, cardiac pacemaker
Trial locations and contacts
23 sites in 4 countries.
23 sites in 4 countries
United Kingdom20 sites
Royal United Hospital NHS Trust
Bath, BA1 3NG
Sandwell and West Birmingham Hospitals NHS Trust
Birmingham, B18 7QH
Epsom and St Helier's Hospitals NHS Trust
Carshalton, Surrey, SM5 1AA
St Richard's Hospital
Chichester, West Sussex, PO19 6SE
Essex County Hospital
Colchester, Essex, CO3 3NB
Croydon University Hospital
Croydon, CR7 7YE
Dorset County Hospital NHS Foundation Trust
Dorchester, Dorset, DT1 2JY
County Durham and Darlington NHS Trust (University Hospital of North Durham)
Durham, County Durham, DH1 5TW
Medway NHS Foundation Trust
Gillingham, Kent, ME7 5NY
James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, Norfolk, NR31 6LA
North West London Hospitals NHS Trust (Northwick Park Hospital)
Harrow, Middlesex, HA1 3UJ
Hinchingbrooke Hospital
Huntingdon, Cambridgeshire, PE29 6NT
St Bartholomew's Hospital
London, EC1A 7BE
St George's Healthcare NHS Trust
London, SW17 0QT
Pennine Acute Hospitals NHS Trust
Manchester, M8 5RB
Poole Hospital NHS Foundation Trust
Poole, Dorset, BH15 2JB
Portsmouth Hospitals NHS Trust (Queen Alexandra Hospital)
Portsmouth, Hampshire, PO6 3LY
North Tees and Hartlepool NHS Trust (University Hospital of North Tees)
Stockton-on-Tees, County Durham, TS24 9AH
Royal Marsden NHS Trust
Sutton, SM2 5PT
Mid Yorkshire Hospitals NHS Trust (Pinderfields Hospital)
Wakefield, West Yorkshire, WF1 4DG
About this study
Official title: Is Greater Downstaging and Tumour Regression Observed When Surgery is Delayed to 12 Weeks After Completion of Chemoradiotherapy vs 6 Weeks?
The aim of this study is to determine whether greater rectal cancer downstaging and regression occurs when surgery is delayed to 12 weeks after completion of radiotherapy/chemotherapy compared to 6 weeks.
Hypothesis: Greater downstaging and tumour regression is observed when surgery is delayed to 12 weeks after completion of CRT compared to 6 weeks.
- Conditions
- Adenocarcinoma of the Rectum, Adenocarcinoma, Adenocarcinoma, Mucinous, Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type
- Being tested
- Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy
- Keywords
- Rectal Cancer, 6vs12, 6 vs 12, Cancer, CRM, Circumferential Resection Margin, Quality of Life, MRI, Radiology, Abdominoperineal Excision, Anterior Resection, Surgery, Pathology, Radiotherapy
- Medical subject headings
- Rectal Neoplasms, Adenocarcinoma, Adenocarcinoma, Mucinous, Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms, Neoplasms, Cystic, Mucinous, and Serous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapyOther
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | No intervention | Patients who have surgery at 6 weeks after radiotherapy/chemoradiotherapy |
| Group 2 | Experimental | Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy Receives: Other: Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the difference in the proportion of patients in each arm, downstaged according to T stage [on MRI].
Measured: 6-12 weeks
Secondary outcomes (6)
Tumour response using SUV measurements [PET/CT], N downstaging and Tumour Regression Grade downstaging [on MRI].
Measured: 3 months
Difference in proportion of patients in each arm undergoing sphincter saving surgery.
Measured: 3 months
Morbidity, 30 day mortality and CRM (circumferential resection margin) positivity.
Measured: 3 months
An analysis will also be undertaken using multivariate and linear regression analysis to evaluate the association of ypT and ypN stage as a potential independent predictors of SUV (max) baseline and after radiotherapy (pre-surgery) in the two arms.
Measured: 3 months
Local and distant recurrence rates.
Measured: 5 years
Radiotherapy related toxicity rates.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study start16 Oct 2009
- Primary completion8 Dec 2014
- Study completion8 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenocarcinoma of the RectumStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diana Tait, Principal investigator, Royal Marsden NHS Foundation TrustGina Brown, Principal investigator, Royal Marsden Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01037049
- Sponsor's protocol ID
- CCR3227
- Status last verified
- Sep 2018
- First submitted
- 18 Dec 2009
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Greater Downstaging and Tumour Regression Observed When Surgery is Delayed to 12 Weeks After Completion of Chemoradiotherapy vs 6 Weeks?
- ClinicalTrials.gov ID
- NCT01037049
- Acronym / sponsor ID
- CCR3227
- Conditions
- Adenocarcinoma of the Rectum, Adenocarcinoma, Adenocarcinoma, Mucinous, Carcinoma, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type
- Keywords
- Rectal Cancer, 6vs12, 6 vs 12, Cancer, CRM, Circumferential Resection Margin, Quality of Life, MRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 16 Oct 2009 (actual)
- Primary completion
- 8 Dec 2014 (actual)
- Study completion
- 8 Dec 2019 (estimated)
- First posted
- 21 Dec 2009 (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.
The aim of this study is to determine whether greater rectal cancer downstaging and regression occurs when surgery is delayed to 12 weeks after completion of radiotherapy/chemotherapy compared to 6 weeks.
Hypothesis: Greater downstaging and tumour regression is observed when surgery is delayed to 12 weeks after completion of CRT compared to 6 weeks.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | No intervention | –Patients who have surgery at 6 weeks after radiotherapy/chemoradiotherapy |
| Group 2 | Experimental | Other: Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapyPatients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged > 18
- Informed written consent
- Histological confirmation of adenocarcinoma of rectum
- Undergoing pre-operative radiotherapy/ chemotherapy
- Completion of pre-operative treatment
Key exclusion criteria (4 listed)
- Aged < 18
- Absence of pre-operative RT/CT
- Medical/ psychiatric conditions that compromise the patients ability to give informed consent
- Contra-indications to MRI, i.e. hip prothesis, cardiac pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy | Other | Group 2 |
Primary outcome
The primary endpoint will be the difference in the proportion of patients in each arm, downstaged according to T stage [on MRI].
Time frame: 6-12 weeks
6 secondary outcomes
Tumour response using SUV measurements [PET/CT], N downstaging and Tumour Regression Grade downstaging [on MRI].
Time frame: 3 months
Difference in proportion of patients in each arm undergoing sphincter saving surgery.
Time frame: 3 months
Morbidity, 30 day mortality and CRM (circumferential resection margin) positivity.
Time frame: 3 months
An analysis will also be undertaken using multivariate and linear regression analysis to evaluate the association of ypT and ypN stage as a potential independent predictors of SUV (max) baseline and after radiotherapy (pre-surgery) in the two arms.
Time frame: 3 months
Local and distant recurrence rates.
Time frame: 5 years
Radiotherapy related toxicity rates.
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
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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.
Diana Tait principal investigator
Royal Marsden NHS Foundation Trust
Gina Brown principal investigator
Royal Marsden Hospitals NHS Foundation Trust
23 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Patients who have surgery at 12 weeks after radiotherapy/chemoradiotherapy in people with Adenocarcinoma of the Rectum and Adenocarcinoma, run by Royal Marsden NHS Foundation Trust at 23 sites in 4 countries.
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 5 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: status not confirmed, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United Kingdom, Brazil, Canada, Cyprus. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
The primary endpoint will be the difference in the proportion of patients in each arm, downstaged according to T stage [on MRI]. (time frame: 6-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2018.