Pancreatic CancerPhase 2SCALOPNCT01032057
Gemcitabine, Capecitabine, and Radiation Therapy in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery
A Phase 2 study testing capecitabine, gemcitabine hydrochloride and quality-of-life assessment in people with Pancreatic Cancer, run by Lisette Nixon at 26 sites in United Kingdom.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- capecitabine, gemcitabine hydrochloride and quality-of-life assessment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 26 sitesUnited Kingdom
- Study dates
- Jul 2009to Jun 2013
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Locally advanced, nonmetastatic, inoperable, or operable (but medically unfit for surgery) disease
- Palliative bypass procedure allowed
- Common bile duct stenting allowed
- Primary pancreatic lesion ≤ 7 cm in diameter as measured by CT scan of the thorax and abdomen within 4 weeks prior to registration
- No recurrent cancer following definitive pancreatic surgery
PATIENT CHARACTERISTICS:
- WHO performance status (PS) 0-2
- Neutrophil count ≥ 1.5 x 10^9/L
- Platelet count ≥ 100 x 10^9/L
- Hemoglobin ≥ 10 g/dL
- Serum bilirubin < 35 μmol/L (50 μmol/L allowed for patients who have had a recent biliary drain and whose bilirubin is descending)
- AST/ALT ≤ 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 5 times ULN
- GFR > 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 12 weeks after completion of study therapy
- No evidence of severe uncontrolled systemic diseases including uncontrolled coronary artery disease
- No myocardial infarction or stroke within the past 6 months
- No prior malignancies within the past 5 years except for carcinoma in situ of the cervix, adequately treated basal cell skin carcinoma, or any early-stage malignancy
- No suspected DPD deficiency
- No renal abnormalities (e.g., adult polycystic kidney disease, hydronephrosis, or ipsilateral single kidney)
- Must meet the following additional criteria for randomization:
- WHO PS 0-1
- Loss of weight no greater than 10% of that at baseline
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 4 weeks since prior and no concurrent sorivudine or analogues
- No prior radiotherapy to the upper abdomen
- No concurrent methotrexate
- No concurrent allopurinol
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United Kingdom26 sites
Ysbyty Gwynedd
Bangor, Wales, LL57 2PW
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, B15 2TH
Bristol Haematology and Oncology Centre
Bristol, England, BS2 8ED
Addenbrooke's Hospital
Cambridge, England, CB2 2QQ
Velindre Cancer Center at Velindre Hospital
Cardiff, Wales, CF14 2TL
Queen Alexandra Hospital
Cosham, England, PO6 3LY
Castle Hill Hospital
Cottingham, England, HU16 5JQ
Ninewells Hospital
Dundee, Scotland, DD1 9SY
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, G12 0YN
Diana Princess of Wales Hospital
Grimsby, England, DN33 2BA
St. Luke's Cancer Centre at Royal Surrey County Hospital
Guildford, England, GU2 7XX
Raigmore Hospital
Inverness, Scotland, 1V2 3UJ
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Leicester Royal Infirmary
Leicester, England, LE1 5WW
Helen Rollason Cancer Care Centre at North Middlesex Hospital
London, England, N18 1QX
Royal Free Hospital
London, England, NW3 2QG
Hammersmith Hospital
London, England, W12 OHS
Northampton General Hospital
Northampton, England, NN1 5BD
Perth Royal Infirmary
Perth, Scotland, PH1 1NX
Edith Cavell Hospital
Peterborough, PE3 9EZ
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, LL 18 5UJ
Scarborough General Hospital
Scarborough, England, YO12 6QL
Cancer Research Centre at Weston Park Hospital
Sheffield, England, S10 2SJ
Southampton General Hospital
Southampton, England, SO16 6YD
Musgrove Park Hospital
Taunton, England, TA1 5DA
Wrexham Maelor Hospital
Wrexham, Wales, LL13 7TD
About this study
Official title: A Multi-Center Randomized Phase II Study of Induction Chemotherapy Followed by Gemcitabine or Capecitabine Based Chemoradiotherapy for Locally Advanced Non-Metastatic Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy that uses a 3-dimensional image of the tumor to help focus thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter period of time, may kill more tumor cells and have fewer side effects. It is not yet known which regimen of chemotherapy given together with radiation therapy is more effective in treating pancreatic cancer.
PURPOSE: This randomized phase II trial is comparing the side effects of two regimens of gemcitabine and capecitabine given together with radiation therapy and to see how well they work in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.
Read the detailed description
OBJECTIVES:
- To evaluate the activity, safety, and feasibility of induction chemotherapy comprising gemcitabine and capecitabine followed by two different schedules of chemoradiotherapy comprising gemcitabine or capecitabine and radiotherapy in patients with locally advanced, nonmetastatic, unresectable pancreatic cancer.
- To determine which of the two experimental arms gives the highest generic and disease-specific aspects of health-related quality of life (HRQL) following treatment.
- To determine how HRQL varies during treatment and follow up in both arms.
OUTLINE: This is a multicenter study.
All patients receive a first induction therapy comprising gemcitabine IV on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Following the first induction therapy, patients with a WHO performance status of 0-1 who are responding or have stable disease that can be encompassed within a radically treatable radiotherapy volume are randomized to 1 of 2 treatment arms.
- Arm I:
- Second induction therapy (weeks 13-16): Patients receive gemcitabine IV once daily on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21.
- Chemoradiotherapy (weeks 17-22): Patients receive gemcitabine IV once weekly on day 1 and undergo conformal radiotherapy 5 days a week for 5.5 weeks.
- Arm II:
- Second induction therapy (weeks 13-16): Patients receive gemcitabine IV once daily on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21.
- Chemoradiotherapy (weeks 17-22): Patients receive oral capecitabine twice daily on days 1-5 and undergo conformal radiotherapy 5 days a week for 5.5 weeks.
Patients complete quality-of-life questionnaires QLQ-C30 and PAN26 at baseline and at 17, 23, 26, 39, and 52 weeks.
After completion of study treatment, patients are followed every 3 months.
- Conditions
- Pancreatic Cancer
- Being tested
- capecitabine, gemcitabine hydrochloride, quality-of-life assessment, 3-dimensional conformal radiation therapy
- Keywords
- adenocarcinoma of the pancreas, stage II pancreatic cancer, stage III pancreatic cancer
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capecitabineDrug
quality-of-life assessmentProcedure or surgery
3-dimensional conformal radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine | Active comparator | GEMCAP induction chemotherapy (28 day cycle of IV gemcitabine 1000mg/m2 day 1, 8,15 and capecitabine 830mg/m2 bd for 21 days po) followed by gemcitabine 300mg/m2 weekly (IV) + 50.4Gy radiation over five and half weeks (1.8Gy per fraction, Monday-Friday) Receives: Drug: capecitabine; Drug: gemcitabine hydrochloride; Procedure: quality-of-life assessment; Radiation: 3-dimensional conformal radiation therapy |
| chemoradiotherpay with capecitabine | Active comparator | GEMCAP induction chemotherapy (28 day cycle of IV gemcitabine 1000mg/m2 day 1, 8,15 and capecitabine 830mg/m2 bd for 21 days po), followed by capecitabine 830mg/m2 bd (po, Mon-Fri) + 50.4Gy radiation over five and half weeks (1.8Gy per fraction, Monday-Friday) Receives: Drug: capecitabine; Drug: gemcitabine hydrochloride; Procedure: quality-of-life assessment; Radiation: 3-dimensional conformal radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival at 39 weeks (from registration) according to RECIST criteria
Measured: Assessed 39 weeks from registration
Secondary outcomes (6)
Toxicity according to NCI CTCAE v.3.0
Measured: Assessed throughout trial treatment and follow-up
Quality of life as measured by questionnaires QLQ-C30 and PAN26 at baseline and at 17, 23, 26, 39, and 52 weeks
Measured: Assessed throughout trial treatment and follow-up
Overall survival at 52 weeks and time from registration to death by any cause
Measured: Assessed 52 weeks post registration and during NHS flagging
Objective disease response according to RECIST criteria
Measured: 39 weeks post registration
Progression-free survival (time to event) according to RECIST criteria
Measured: Assessed during NHS flagging at the end of the trial
Radiotherapy quality assurance (adherence to protocol)
Measured: Upon completion of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startJul 2009
- Primary completionJan 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pancreatic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lisette Nixon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lisette Nixon, Cardiff University
- Investigators
- Somnath Mukherjee, Principal investigator, Northampton General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01032057
- Sponsor's protocol ID
- CDR0000660755
- Other IDs
- WCTU-SCALOP, EUDRACT-2008-001394-15, ISRCTN-96169987, WCTU-SPON-415-07, CRUK-07/040, EU-21114
- Acronym
- SCALOP
- Status last verified
- Oct 2018
- First submitted
- 13 Dec 2009
- Last updated
- 26 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mukherjee S, Hurt CN, Bridgewater J, Falk S, Cummins S, Wasan H, Crosby T, Jephcott C, Roy R, Radhakrishna G, McDonald A, Ray R, Joseph G, Staffurth J, Abrams RA, Griffiths G, Maughan T. Gemcitabine-based or capecitabine-based chemoradiotherapy for locally advanced pancreatic cancer (SCALOP): a multicentre, randomised, phase 2 trial. Lancet Oncol. 2013 Apr;14(4):317-26. doi: 10.1016/S1470-2045(13)70021-4. Epub 2013 Mar 6.
PubMed 23474363Fokas E, Spezi E, Patel N, Hurt C, Nixon L, Chu KY, Staffurth J, Abrams R, Mukherjee S. Comparison of investigator-delineated gross tumour volumes and quality assurance in pancreatic cancer: Analysis of the on-trial cases for the SCALOP trial. Radiother Oncol. 2016 Aug;120(2):212-6. doi: 10.1016/j.radonc.2016.07.002. Epub 2016 Aug 3.
PubMed 27497804Fokas E, Clifford C, Spezi E, Joseph G, Branagan J, Hurt C, Nixon L, Abrams R, Staffurth J, Mukherjee S. Comparison of investigator-delineated gross tumor volumes and quality assurance in pancreatic cancer: Analysis of the pretrial benchmark case for the SCALOP trial. Radiother Oncol. 2015 Dec;117(3):432-7. doi: 10.1016/j.radonc.2015.08.026. Epub 2015 Aug 29.
PubMed 26328939
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Randomized Phase II Study of Induction Chemotherapy Followed by Gemcitabine or Capecitabine Based Chemoradiotherapy for Locally Advanced Non-Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01032057
- Acronym / sponsor ID
- SCALOP / CDR0000660755
- Conditions
- Pancreatic Cancer
- Keywords
- adenocarcinoma of the pancreas, stage II pancreatic cancer, stage III pancreatic cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Lisette NixonUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 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.
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy that uses a 3-dimensional image of the tumor to help focus thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter period of time, may kill more tumor cells and have fewer side effects. It is not yet known which regimen of chemotherapy given together with radiation therapy is more effective in treating pancreatic cancer.
PURPOSE: This randomized phase II trial is comparing the side effects of two regimens of gemcitabine and capecitabine given together with radiation therapy and to see how well they work in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.
Detailed description
OBJECTIVES:
- To evaluate the activity, safety, and feasibility of induction chemotherapy comprising gemcitabine and capecitabine followed by two different schedules of chemoradiotherapy comprising gemcitabine or capecitabine and radiotherapy in patients with locally advanced, nonmetastatic, unresectable pancreatic cancer.
- To determine which of the two experimental arms gives the highest generic and disease-specific aspects of health-related quality of life (HRQL) following treatment.
- To determine how HRQL varies during treatment and follow up in both arms.
OUTLINE: This is a multicenter study.
All patients receive a first induction therapy comprising gemcitabine IV on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Following the first induction therapy, patients with a WHO performance status of 0-1 who are responding or have stable disease that can be encompassed within a radically treatable radiotherapy volume are randomized to 1 of 2 treatment arms.
- Arm I:
- Second induction therapy (weeks 13-16): Patients receive gemcitabine IV once daily on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21.
- Chemoradiotherapy (weeks 17-22): Patients receive gemcitabine IV once weekly on day 1 and undergo conformal radiotherapy 5 days a week for 5.5 weeks.
- Arm II:
- Second induction therapy (weeks 13-16): Patients receive gemcitabine IV once daily on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21.
- Chemoradiotherapy (weeks 17-22): Patients receive oral capecitabine twice daily on days 1-5 and undergo conformal radiotherapy 5 days a week for 5.5 weeks.
Patients complete quality-of-life questionnaires QLQ-C30 and PAN26 at baseline and at 17, 23, 26, 39, and 52 weeks.
After completion of study treatment, patients are followed every 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine | Active comparator | Drug: capecitabine, Drug: gemcitabine hydrochloride, Procedure: quality-of-life assessment, Radiation: 3-dimensional conformal radiation therapyGEMCAP induction chemotherapy (28 day cycle of IV gemcitabine 1000mg/m2 day 1, 8,15 and capecitabine 830mg/m2 bd for 21 days po) followed by gemcitabine 300mg/m2 weekly (IV) + 50.4Gy radiation over five and half weeks (1.8Gy per fraction, Monday-Friday) |
| chemoradiotherpay with capecitabine | Active comparator | Drug: capecitabine, Drug: gemcitabine hydrochloride, Procedure: quality-of-life assessment, Radiation: 3-dimensional conformal radiation therapyGEMCAP induction chemotherapy (28 day cycle of IV gemcitabine 1000mg/m2 day 1, 8,15 and capecitabine 830mg/m2 bd for 21 days po), followed by capecitabine 830mg/m2 bd (po, Mon-Fri) + 50.4Gy radiation over five and half weeks (1.8Gy per fraction, Monday-Friday) |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| capecitabine | Drug | Gemcitabine, chemoradiotherpay with capecitabine |
| gemcitabine hydrochloride | Drug | Gemcitabine, chemoradiotherpay with capecitabine |
| quality-of-life assessment | Procedure or surgery | Gemcitabine, chemoradiotherpay with capecitabine |
| 3-dimensional conformal radiation therapy | Radiation | Gemcitabine, chemoradiotherpay with capecitabine |
Primary outcome
Progression-free survival at 39 weeks (from registration) according to RECIST criteria
Time frame: Assessed 39 weeks from registration
6 secondary outcomes
Toxicity according to NCI CTCAE v.3.0
Time frame: Assessed throughout trial treatment and follow-up
Quality of life as measured by questionnaires QLQ-C30 and PAN26 at baseline and at 17, 23, 26, 39, and 52 weeks
Time frame: Assessed throughout trial treatment and follow-up
Overall survival at 52 weeks and time from registration to death by any cause
Time frame: Assessed 52 weeks post registration and during NHS flagging
Objective disease response according to RECIST criteria
Time frame: 39 weeks post registration
Progression-free survival (time to event) according to RECIST criteria
Time frame: Assessed during NHS flagging at the end of the trial
Radiotherapy quality assurance (adherence to protocol)
Time frame: Upon completion of the trial
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 26 Oct 2018.
- Results publication: PubMed 23474363Mukherjee S, Hurt CN, Bridgewater J, Falk S, Cummins S, Wasan H, Crosby T, Jephcott C, Roy R, Radhakrishna G, McDonald A, Ray R, Joseph G, Staffurth J, Abrams RA, Griffiths G, Maughan T. Gemcitabine-based or capecitabine-based chemoradiotherapy for locally advanced pancreatic cancer (SCALOP): a multicentre, randomised, phase 2 trial. Lancet Oncol. 2013 Apr;14(4):317-26. doi: 10.1016/S1470-2045(13)70021-4. Epub 2013 Mar 6.
- Results publication: PubMed 27497804Fokas E, Spezi E, Patel N, Hurt C, Nixon L, Chu KY, Staffurth J, Abrams R, Mukherjee S. Comparison of investigator-delineated gross tumour volumes and quality assurance in pancreatic cancer: Analysis of the on-trial cases for the SCALOP trial. Radiother Oncol. 2016 Aug;120(2):212-6. doi: 10.1016/j.radonc.2016.07.002. Epub 2016 Aug 3.
- Results publication: PubMed 26328939Fokas E, Clifford C, Spezi E, Joseph G, Branagan J, Hurt C, Nixon L, Abrams R, Staffurth J, Mukherjee S. Comparison of investigator-delineated gross tumor volumes and quality assurance in pancreatic cancer: Analysis of the pretrial benchmark case for the SCALOP trial. Radiother Oncol. 2015 Dec;117(3):432-7. doi: 10.1016/j.radonc.2015.08.026. Epub 2015 Aug 29.
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
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.
Somnath Mukherjee principal investigator
Northampton General Hospital
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing capecitabine, gemcitabine hydrochloride and quality-of-life assessment in people with Pancreatic Cancer, run by Lisette Nixon at 26 sites 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?
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 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites 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.
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?
Progression-free survival at 39 weeks (from registration) according to RECIST criteria (time frame: Assessed 39 weeks from registration). 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 NCT01032057, which also lists 3 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 26 Oct 2018.