Rectal CancerPhase 2NCT00220051
A Phase II Study of Oxaliplatin Capecitabine and Pre-operative Radiotherapy for Patients With Locally Advanced and Inoperable Rectal Cancer
A Phase 2 study testing Oxaliplatin, Capecitabine, Pre operative radiotherapy and Surgical Resection in people with Rectal Cancer, run by Royal Marsden NHS Foundation Trust.
Trial summary
To assess the efficacy and safety of pre-operative capecitabine and oxaliplatin followed by capecitabine with concurrent radiotherapy followed by post-operative capecitabine in the treatment of patients with locally advanced or inoperable rectal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Oxaliplatin, Capecitabine, Pre operative radiotherapy and Surgical Resection
- Type of treatment
- Surgery or procedure
- How many people
- 109 participants
- Where
- No sites listed yet
- Study dates
- Nov 2001to not given
- 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
- Age over 18.
- Histological diagnosis of adenocarcinoma of rectum.
- Locally advanced/ poor prognosis primary rectal cancer defined by MRI criteria of any of the categories below;
- Tumour within 2 mm of mesorectal fascia ie circumferential resection margin threatened
- Any T3 tumour at/below levatores
- T3c tumour at any other level ie tumour extends >5 mm into peri-rectal fat
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- T4 tumour
- Any T stage with 4 or more involved lymph nodes
- WHO performance status 0, 1 or 2.
- No evidence of metastatic disease as determined by CT scan of chest, abdomen, pelvis or other investigations such as PET scan or biopsy if required.
- Adequate bone marrow function with platelets > 100 X 109/l; WBC > 3 X 109/l; neutrophils > 1.5 X 109/l
- Normal renal function, with serum creatinine within the normal range or calculated creatinine clearance >50 ml/min.
- Adequate hepatic function with serum total bilirubin < 1.5 X upper limit of normal range.
- No concurrent uncontrolled medical conditions
- No previous malignant disease other than non-melanotic skin cancer or carcinoma in situ of the uterine cervix
- Adequate contraceptive precautions if relevant
- Informed written consent
Who cannot join
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent
- Presence of metastatic disease or recurrent rectal tumour
- Renal impairment (creatinine clearance<30 ml/min)
- Pregnancy or breast feeding
- Patients with a lack of physical integrity of the upper gastrointestinal tract, or known malabsorption syndromes
- Participation in any investigational drug study within the previous 4 weeks.
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- Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia even if controlled with medication) or myocardial infarction within the last 12 months)
- Patients with any symptoms or history of peripheral neuropathy.
- Prior pelvic radiotherapy
About this study
Official title: A Phase II Study of Oxaliplatin (Eloxatin) Capecitabine (Xeloda) and Pre-operative Radiotherapy for Patients With Locally Advanced and Inoperable Rectal Cancer.
To assess the efficacy and safety of pre-operative capecitabine and oxaliplatin followed by capecitabine with concurrent radiotherapy followed by post-operative capecitabine in the treatment of patients with locally advanced or inoperable rectal cancer.
- Conditions
- Rectal Cancer
- Being tested
- Oxaliplatin, Capecitabine, Pre operative radiotherapy, Surgical Resection
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxaliplatin, CapecitabineDrug
Pre operative radiotherapyProcedure or surgery
Surgical ResectionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate.
Acute toxicity has been evaluated in previous phase I studies and should occur to a similar extent.
Secondary outcomes (7)
Progression-free survival
Treatment related toxicity
Overall survival
Radiological response rate
Proportion of patients achieving pathological down staging compared with the pre-treatment MRI scan
Surgical complications
Bowel function and quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startNov 2001
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 Rectal CancerStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- D Cunningham, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00220051
- Sponsor's protocol ID
- 1973
- Status last verified
- May 2013
- First submitted
- 19 Sep 2005
- Last updated
- 31 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Chua YJ, Barbachano Y, Cunningham D, Oates JR, Brown G, Wotherspoon A, Tait D, Massey A, Tebbutt NC, Chau I. Neoadjuvant capecitabine and oxaliplatin before chemoradiotherapy and total mesorectal excision in MRI-defined poor-risk rectal cancer: a phase 2 trial. Lancet Oncol. 2010 Mar;11(3):241-8. doi: 10.1016/S1470-2045(09)70381-X. Epub 2010 Jan 25.
PubMed 20106720
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Oxaliplatin (Eloxatin) Capecitabine (Xeloda) and Pre-operative Radiotherapy for Patients With Locally Advanced and Inoperable Rectal Cancer.
- ClinicalTrials.gov ID
- NCT00220051
- Acronym / sponsor ID
- 1973
- Conditions
- Rectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Nov 2001
- First posted
- 22 Sep 2005 (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.
To assess the efficacy and safety of pre-operative capecitabine and oxaliplatin followed by capecitabine with concurrent radiotherapy followed by post-operative capecitabine in the treatment of patients with locally advanced or inoperable rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age over 18.
- Histological diagnosis of adenocarcinoma of rectum.
- Locally advanced/ poor prognosis primary rectal cancer defined by MRI criteria of any of the categories below;
- WHO performance status 0, 1 or 2.
- No evidence of metastatic disease as determined by CT scan of chest, abdomen, pelvis or other investigations such as PET scan or biopsy if required.
Key exclusion criteria (9 listed)
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent
- Presence of metastatic disease or recurrent rectal tumour
- Renal impairment (creatinine clearance<30 ml/min)
- Pregnancy or breast feeding
- Patients with a lack of physical integrity of the upper gastrointestinal tract, or known malabsorption syndromes
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 |
|---|---|---|
| Oxaliplatin, Capecitabine | Drug | – |
| Pre operative radiotherapy | Procedure or surgery | – |
| Surgical Resection | Procedure or surgery | – |
Primary outcome
Pathological complete response rate.
Acute toxicity has been evaluated in previous phase I studies and should occur to a similar extent.
7 secondary outcomes
Progression-free survival
Treatment related toxicity
Overall survival
Radiological response rate
Proportion of patients achieving pathological down staging compared with the pre-treatment MRI scan
Surgical complications
Bowel function and quality of life
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 31 May 2013.
- Derived from this study: PubMed 20106720Chua YJ, Barbachano Y, Cunningham D, Oates JR, Brown G, Wotherspoon A, Tait D, Massey A, Tebbutt NC, Chau I. Neoadjuvant capecitabine and oxaliplatin before chemoradiotherapy and total mesorectal excision in MRI-defined poor-risk rectal cancer: a phase 2 trial. Lancet Oncol. 2010 Mar;11(3):241-8. doi: 10.1016/S1470-2045(09)70381-X. Epub 2010 Jan 25.
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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.
D Cunningham principal investigator
Royal Marsden NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxaliplatin, Capecitabine, Pre operative radiotherapy and Surgical Resection in people with Rectal Cancer, run by Royal Marsden NHS Foundation Trust.
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 17 inclusion and 9 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 31 May 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Pathological complete response rate.. The study lists 2 primary outcomes in all. 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 NCT00220051, 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 31 May 2013.