Colorectal CancerPhase 3ASCOLTNCT00565708
Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers
A Phase 3 study testing Acetylsalicylic acid in people with Colorectal Cancer, run by National Cancer Centre, Singapore at 67 sites in 10 countries.
Trial summary
We hypothesize through this randomized, placebo-controlled adjuvant study, that Aspirin in patients with dukes C or high risk dukes B colorectal cancer (ASCOLT) can improve survival in this patient population over placebo control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Acetylsalicylic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,587 participants
- Where
- 67 sitesin 10 countries
- Study dates
- Dec 2008to Jun 2024
- Phase
- Phase 3
- 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
- Male or female outpatient of ≥ 18 years of age or ≥ country's legal age for adult consent
- Dukes C colon cancer, high risk Dukes B colon cancer, Dukes B rectal cancer or Dukes C rectal cancer (see Appendix 1 for definition of High Risk Dukes B)
- Undergone complete resection of primary tumour
- Completed standard therapy ( at least 3 months of chemotherapy ± radiotherapy )
- Within 120 days of completion of standard therapy (surgery, chemotherapy ± radiotherapy)
- ECOG performance status 0 to 2
Show all 16Show fewer
- Satisfactory haematological or biochemical functions (tests should be carried out within 8 weeks prior to randomisation): Results of clinical investigations carried out within 8 weeks prior to randomisation can be used in place of the required screening investigations. Patients with mild laboratory abnormalities can be included at the discretion by the site principal investigator, and after approval by ASCOLT Trial Management Group
- ANC ≥ 1.0 x 109/L
- Platelets ≥ 100 x 109/L
- Creatinine clearance ≥ 30 mL/min
- Total bilirubin ≤ 2.0 x the upper limit normal
- AST \& ALT ≤ 5 x the upper limit normal
- Completed the following investigations
- Colonoscopy(or CT colonogram(within 16 months prior to randomization)
- Imaging of abdomen (CT or CT colonogram or MRI or PET or Ultrasound) within 16 months prior to randomization
- Written informed consent
Who cannot join
- Pre-existing Familial adenomatous polyposis, inflammatory bowel disease or ulcerative colitis
- Active gastritis or active peptic ulcer
- History of continuous daily use of PPI more than 1 year prior to consent
- Gastrointestinal bleeding within the past one year
- Haemorrhagic diathesis (i.e. haemophilia)
- Uncontrolled hypertension (untreated systolic blood pressure > 160 mmHg, or diastolic blood pressure > 95 mmHg)
Show all 17Show fewer
- History of recent cancers (except for colorectal cancers, non-melanoma skin cancers, basal cell carcinomas, squamous cell carcinomas) in the past 5 years
- History of stroke, coronary arterial disease, angina, or vascular disease
- Patients who are on current long term treatment (≥ 4 consecutive weeks) with Aspirin, NSAID or Cox-2 inhibitors
- History of erosive GERD or active erosive GERD on gastroscopy.
- Patient on active current treatment of antiplatelet agents (i.e. off-study Aspirin, clopidogrel, ticlopidine)
- Patient receiving active treatment of anticoagulants (i.e. warfarin, low molecular weight heparins)
- Pregnant, lactating, or not using adequate contraception
- Patient having known allergy to NSAID or Aspirin
- Unexplained rise of CEA (i.e. smoker with elevated CEA will not be excluded)
- Patient on other investigational drug
- Patients with HNPCC (Lynch Syndrome)
Trial locations and contacts
67 sites in 10 countries.
67 sites in 10 countries
Australia29 sites
Border Medical Oncology Research Unit
Albury, Victoria
Ballarat Regional Integrated Cancer Centre
Ballarat, Victoria, 3350
Bankstown-Lidcombe Hospital Bankstown Cancer Centre
Bankstown, New South Wales
Macarthur Cancer Therapy Centre
Campbelltown, New South Wales
Chris O'Brien Lifehouse, Clinical Research Centre
Camperdown, New South Wales, 2050
Coffs Harbour Health Campus North Coast Cancer Institute
Coffs Harbour, New South Wales, 2450
Townsville Hospital
Douglas, Queensland, 4814
Lyell McEwin Hospital
Elizabeth Vale, South Australia, 5112
Barwon Health Andrew Love Cancer Centre
Geelong, Victoria
Central Coast Cancer Centre Gosford Hospital
Gosford, New South Wales, 2050
Austin Health Cancer Clinical Trials
Heidelberg, Victoria
Royal Brisbane and Women's Hospital
Herston, Queensland
Royal Hobart Hospital
Hobart, Tasmania, 7000
Launceston General Hospital
Launceston, Victoria
Monash Health Medical Oncology
Melbourne, Victoria, 3165
Sir Charles Gairdner Hospital
Nedlands, Western Australia
Newcastle private Hospital
New Lambton Heights, New South Wales, 2305
Orange Health Service
Orange, New South Wales
Port Macquarie Base Hospital North Coast Cancer Institute
Port Macquarie, New South Wales, 2444
Goulburn Valley Health
Shepparton, Victoria, 3630
Northern Cancer Institute, St Leonards
St Leonards, New South Wales, 2065
St John of God Hospital Subiaco
Subiaco, Western Australia
St Vincent's Hospital
Sydney, New South Wales
Northwest Cancer Centre Tamworth Hospital
Tamworth, New South Wales, 2340
Royal Darwin Hospital
Tiwi, Northern Territory
Toowoomba Hospital
Toowoomba, Queensland
The Tweed Hospital
Tweed Heads, New South Wales
Calvary Mater Newcastle Hospital
Waratah, New South Wales
St John of God Healthcare Southwest Oncology
Warrnambool, Victoria, 3280
China15 sites
Beijing University Cancer Hospital
Beijing, Beijing Municipality
The First People's Hospital of Foshan City
Foshan, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong
Sixth Affiliated Hospital
Guangzhou, Guangdong
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang
Queen Mary Hospital - Hong Kong
Hong Kong
Jinan Central Hospital
Jinan, Shandong
Affiliated Hospital of Nantong University
Nantong, Jiangsu
Shuang Ho Hospital
Taibei, Taiwan, 23561
Koo Foundation Sun Yat Sen Cancer Centre
Taibei, Taiwan
Taipei Medical University Hospital
Taibei, Taiwan
Wan Fang Hospital
Taibei, Taiwan
Yantai Yuhuangding Hospital
Yantai, Shandong
Zhongshan City People's Hospital
Zhongshan, Guangdong
India7 sites
Kidwai Memorial Institute of Oncology
Bangalore, 560029
G. Kuppuswamy Naidu Memorial Hospital
Coimbatore, 641 037
Nizam's Institute of Medical Sciences
Hyderabad, 500 082
Tata Memorial Hospital
Mumbai, 400012
All India Institute of Medical Sciences
New Delhi, 110029
Regional Cancer Center
Trivandrum, 695011
Christian Medical College and Hospital
Vellore, 632002
Malaysia4 sites
Hospital Kuala Lumpur
Kuala Lumpur, 50586
University of Malaysia Medical Center
Kuala Lumpur, 59100
University Kebangsaan Malaysia Medical Center
Kuala Lumpur
Sarawak General Hospital
Kuching, Sarawak
Indonesia3 sites
Dharmais Cancer Hospital
Jakarta, 11420
Cipto Mangunkusumo General Hospital
Jakarta
Rumah Sakit RSUP Dr. Sardjito
Yogyakarta, 55284
Singapore3 sites
National Cancer Centre - Singapore
Singapore, 169610
Johns Hopkins Singapore International Medical Center
Singapore
Tan Tock Seng Hospital
Singapore
New Zealand2 sites
Christchurch Public Hospital
Christchurch, 8140
Dunedin Hospital
Dunedin
South Korea2 sites
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do
Severance Hospital
Seoul
About this study
Official title: Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers - An International, Multi-Center, Double Blind, Randomized Placebo Controlled Phase III Trial
We hypothesize through this randomized, placebo-controlled adjuvant study, that Aspirin in patients with dukes C or high risk dukes B colorectal cancer (ASCOLT) can improve survival in this patient population over placebo control. If indeed found to be beneficial, because aspirin is cheap and easy to administer, it will positively impact the lives of many individuals in Asia and globally.
STUDY OBJECTIVE
Read more
To assess the effectiveness of Aspirin against placebo control in patients with dukes C or high risk dukes B colorectal cancer in terms of Disease Free Survival (DFS) and Overall Survival (OS)
Primary endpoints
- DFS among all eligible subjects (high risk Dukes B colon cancer, Dukes C colon cancer and rectal cancer patient sub-groups);
- DFS among patients with colon cancer (high-risk Dukes B and Dukes C colon cancer).
Secondary endpoints
- Overall survival (OS) over 5 years
- DFS and OS in
- Chinese, Malay, Indian and other ethnic groups
- Resected high risk Dukes B colon cancer, Dukes C colon cancer and rectal cancer sub-groups, individually
- Compliant versus non-compliant subjects
- PIK3CA mutated tumors (where samples are available)
Read the detailed description
Aspirin in patients with dukes C or high risk dukes B colorectal cancer can improve survival in this patient population over placebo control.
Eligible patients will be randomized to treatment arms, using the following stratification factors:
- Study Centre
- Tumour Type
- Type of adjuvant chemotherapy received(exposed/not exposed to oxaliplatin
Patients will be randomized over a 5 years' time period. After randomization, patient will have 3 monthly assessments with treatment for 3 years followed by 6 monthly assessments for additional 2 years follow-up
- Conditions
- Colorectal Cancer
- Being tested
- placebo, Acetylsalicylic acid
- Keywords
- stage II colon cancer, stage III colon cancer, stage II rectal cancer, stage III rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
Placebo Comparator
Acetylsalicylic acidDrug
Also called Aspirin
Adjuvant Therapy
| Study group | Role | What they receive |
|---|---|---|
| acetylsalicylic acid | Experimental | 200mg OD for 3 years Receives: Drug: Acetylsalicylic acid |
| Placebo | Placebo comparator | 200mg OD for 3 years Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Recurrence data documented
Measured: 5 years
Secondary outcomes (1)
Overall survival
Death data documented
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 posted30 Nov 2007 (estimated)
- Study startDec 2008
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Colorectal 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,587 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Australasian Gastro-Intestinal Trials Group, INDOX Cancer Research Network, University of Sydney
- Responsible party
- Principal investigator, Toh Han Chong, National Cancer Centre, Singapore
- Investigators
- John Chia, MBBS, MRCP, Study chair, National Cancer Centre, SingaporeRaghib Ali, MBBS,MRCP, Study chair, NYUHan Chong Toh, MD,MBBS,MRCP, Study chair, National Cancer Centre, SingaporeEva Segelov, MBBS,PhD, Study chair, Monash University, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565708
- Sponsor's protocol ID
- CDR0000577892
- Other IDs
- SINGAPORE-ICR-02, SINGAPORE-ASCOLT
- Acronym
- ASCOLT
- Status last verified
- Jan 2024
- First submitted
- 29 Nov 2007
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Segelov E, Prenen H, Day D, Macintyre CR, Foo EMJ, Ali R, Wang Q, Wei X, Lopes GL Jr, Ding K, Chen G, Chia JWK, Toh HC; ASCOLT Investigators. Impact of the COVID-19 Epidemic on a Pan-Asian Academic Oncology Clinical Trial. JCO Glob Oncol. 2020 Apr;6:585-588. doi: 10.1200/GO.20.00072. No abstract available.
PubMed 32293940Day D, Toh HC, Ali R, Foo EMJ, Simes J, Chia JWK, Segelov E; ASCOLT Investigators. Operational Challenges of an Asia-Pacific Academic Oncology Clinical Trial. JCO Glob Oncol. 2023 Jun;9:e2300040. doi: 10.1200/GO.23.00040.
PubMed 37364220Segelov E, Li S, Li I, Mouradov D, Yip S, Day D, Jeffery M, Zielinski R, Nott L, Sun Y, Christie M, Ho GF, Chao TY, Rahman N, Foo E, Chia J, Gebski V, Toh HC, Sieber OM, Simes J. Adjuvant aspirin for colorectal cancer with PIK3CA-mutated and COX-2 overexpressed tumours: the ASCOLT translational research study and meta-analysis. EBioMedicine. 2026 Aug;130:106389. doi: 10.1016/j.ebiom.2026.106389. Epub 2026 Jul 20.
PubMed 42475879Chia JWK, Segelov E, Deng Y, Ho GF, Wang W, Han S, Sharma A, Ding K, Chen G, Jeffery MG, Tham CK, Ahn JB, Nott L, Zielinski R, Chao TY, van Hagen T, Wei PL, Day F, Mehta S, Yau T, Peng J, Hayes TM, Li Y, Gandhi M, Foo EMJ, Rahman N, Rothwell P, Ali R, Simes J, Toh HC. Aspirin after completion of standard adjuvant therapy for colorectal cancer (ASCOLT): an international, multicentre, phase 3, randomised, double-blind, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2025 Mar;10(3):198-209. doi: 10.1016/S2468-1253(24)00387-X. Epub 2025 Jan 14.
PubMed 39824200Ali R, Toh HC, Chia WK; ASCOLT Trial Investigators. The utility of Aspirin in Dukes C and High Risk Dukes B Colorectal cancer--the ASCOLT study: study protocol for a randomized controlled trial. Trials. 2011 Dec 14;12:261. doi: 10.1186/1745-6215-12-261.
PubMed 22168568
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspirin for Dukes C and High Risk Dukes B Colorectal Cancers - An International, Multi-Center, Double Blind, Randomized Placebo Controlled Phase III Trial
- ClinicalTrials.gov ID
- NCT00565708
- Acronym / sponsor ID
- ASCOLT / CDR0000577892
- Conditions
- Colorectal Cancer
- Keywords
- stage II colon cancer, stage III colon cancer, stage II rectal cancer, stage III rectal cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,587 participants (actual)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Collaborators
- Australasian Gastro-Intestinal Trials Group, INDOX Cancer Research Network, University of Sydney
- Study start
- Dec 2008 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 30 Nov 2007 (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.
We hypothesize through this randomized, placebo-controlled adjuvant study, that Aspirin in patients with dukes C or high risk dukes B colorectal cancer (ASCOLT) can improve survival in this patient population over placebo control. If indeed found to be beneficial, because aspirin is cheap and easy to administer, it will positively impact the lives of many individuals in Asia and globally.
STUDY OBJECTIVE
To assess the effectiveness of Aspirin against placebo control in patients with dukes C or high risk dukes B colorectal cancer in terms of Disease Free Survival (DFS) and Overall Survival (OS)
Primary endpoints
- DFS among all eligible subjects (high risk Dukes B colon cancer, Dukes C colon cancer and rectal cancer patient sub-groups);
- DFS among patients with colon cancer (high-risk Dukes B and Dukes C colon cancer).
Secondary endpoints
- Overall survival (OS) over 5 years
- DFS and OS in
- Chinese, Malay, Indian and other ethnic groups
- Resected high risk Dukes B colon cancer, Dukes C colon cancer and rectal cancer sub-groups, individually
- Compliant versus non-compliant subjects
- PIK3CA mutated tumors (where samples are available)
Detailed description
Aspirin in patients with dukes C or high risk dukes B colorectal cancer can improve survival in this patient population over placebo control.
Eligible patients will be randomized to treatment arms, using the following stratification factors:
- Study Centre
- Tumour Type
- Type of adjuvant chemotherapy received(exposed/not exposed to oxaliplatin
Patients will be randomized over a 5 years' time period. After randomization, patient will have 3 monthly assessments with treatment for 3 years followed by 6 monthly assessments for additional 2 years follow-up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acetylsalicylic acid | Experimental | Drug: Acetylsalicylic acid200mg OD for 3 years |
| Placebo | Placebo comparator | Other: placebo200mg OD for 3 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female outpatient of ≥ 18 years of age or ≥ country's legal age for adult consent
- Dukes C colon cancer, high risk Dukes B colon cancer, Dukes B rectal cancer or Dukes C rectal cancer (see Appendix 1 for definition of High Risk Dukes B)
- Undergone complete resection of primary tumour
- Completed standard therapy ( at least 3 months of chemotherapy ± radiotherapy )
- Within 120 days of completion of standard therapy (surgery, chemotherapy ± radiotherapy)
Key exclusion criteria (17 listed)
- Pre-existing Familial adenomatous polyposis, inflammatory bowel disease or ulcerative colitis
- Active gastritis or active peptic ulcer
- History of continuous daily use of PPI more than 1 year prior to consent
- Gastrointestinal bleeding within the past one year
- Haemorrhagic diathesis (i.e. haemophilia)
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 |
|---|---|---|
| placeboPlacebo Comparator | Other | Placebo |
| Acetylsalicylic acidAlso: AspirinAdjuvant Therapy | Drug | acetylsalicylic acid |
Primary outcome
Disease-free survival
Time frame: 5 years
Recurrence data documented
1 secondary outcome
Overall survival
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 2 Feb 2024.
- Background: PubMed 32293940Segelov E, Prenen H, Day D, Macintyre CR, Foo EMJ, Ali R, Wang Q, Wei X, Lopes GL Jr, Ding K, Chen G, Chia JWK, Toh HC; ASCOLT Investigators. Impact of the COVID-19 Epidemic on a Pan-Asian Academic Oncology Clinical Trial. JCO Glob Oncol. 2020 Apr;6:585-588. doi: 10.1200/GO.20.00072. No abstract available.
- Background: PubMed 37364220Day D, Toh HC, Ali R, Foo EMJ, Simes J, Chia JWK, Segelov E; ASCOLT Investigators. Operational Challenges of an Asia-Pacific Academic Oncology Clinical Trial. JCO Glob Oncol. 2023 Jun;9:e2300040. doi: 10.1200/GO.23.00040.
- Derived from this study: PubMed 42475879Segelov E, Li S, Li I, Mouradov D, Yip S, Day D, Jeffery M, Zielinski R, Nott L, Sun Y, Christie M, Ho GF, Chao TY, Rahman N, Foo E, Chia J, Gebski V, Toh HC, Sieber OM, Simes J. Adjuvant aspirin for colorectal cancer with PIK3CA-mutated and COX-2 overexpressed tumours: the ASCOLT translational research study and meta-analysis. EBioMedicine. 2026 Aug;130:106389. doi: 10.1016/j.ebiom.2026.106389. Epub 2026 Jul 20.
- Derived from this study: PubMed 39824200Chia JWK, Segelov E, Deng Y, Ho GF, Wang W, Han S, Sharma A, Ding K, Chen G, Jeffery MG, Tham CK, Ahn JB, Nott L, Zielinski R, Chao TY, van Hagen T, Wei PL, Day F, Mehta S, Yau T, Peng J, Hayes TM, Li Y, Gandhi M, Foo EMJ, Rahman N, Rothwell P, Ali R, Simes J, Toh HC. Aspirin after completion of standard adjuvant therapy for colorectal cancer (ASCOLT): an international, multicentre, phase 3, randomised, double-blind, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2025 Mar;10(3):198-209. doi: 10.1016/S2468-1253(24)00387-X. Epub 2025 Jan 14.
- Derived from this study: PubMed 22168568Ali R, Toh HC, Chia WK; ASCOLT Trial Investigators. The utility of Aspirin in Dukes C and High Risk Dukes B Colorectal cancer--the ASCOLT study: study protocol for a randomized controlled trial. Trials. 2011 Dec 14;12:261. doi: 10.1186/1745-6215-12-261.
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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.
John Chia, MBBS, MRCP study chair
National Cancer Centre, Singapore
Raghib Ali, MBBS,MRCP study chair
NYU
Han Chong Toh, MD,MBBS,MRCP study chair
National Cancer Centre, Singapore
67 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetylsalicylic acid in people with Colorectal Cancer, run by National Cancer Centre, Singapore at 67 sites in 10 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 16 inclusion and 17 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 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in Australia, China, India, Malaysia, Indonesia and 5 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Disease-free survival (time frame: 5 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 NCT00565708, which also lists 5 linked publications.
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 2 Feb 2024.