Midgut Neuroendocrine TumoursPhase 2CONTROL NETSNCT02358356
Capecitabine ON Temozolomide Radionuclide Therapy Octreotate Lutetium-177 NeuroEndocrine Tumours Study
A Phase 2 study testing octreotate, Capecitabine and Temozolomide in people with Midgut Neuroendocrine Tumours and Pancreatic Neuroendocrine Tumours, run by Australasian Gastro-Intestinal Trials Group at 4 sites in Australia.
Trial summary
Two parallel phase II randomized open label trials of Lutetium-177 Octreotate (177Lu-Octreotate) peptide receptor radionuclide therapy (PRRT) and capecitabine (CAP)/temozolomide (TEM) chemotherapy (chemo): (i) versus CAPTEM alone in the treatment of low to intermediate grade pancreatic neuroendocrine tumours (pNETs)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Midgut Neuroendocrine Tumours, Pancreatic Neuroendocrine Tumours
- What is being tested?
- octreotate, Capecitabine and Temozolomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 4 sitesAustralia
- Study dates
- Nov 2015to 31 Oct 2021
- 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
- Adults ≥18 years old with histologically proven, moderate to well-differentiated G1/2 pancreatic or midgut NETs with Ki-67 < 20%;
- The presence of somatostatin receptor avidity suitable for PRRT demonstrated on 68Ga-octreotate PET scan;
- Progressive advanced/metastatic disease that has progressed during or after ≤ 2 prior systemic therapies;
- Unresectable disease, determined by an appropriately specialized surgeon or deemed not suitable for liver directed therapies where liver is the only site of disease;
- ECOG performance status 0-2;
- Ability to swallow oral medication;
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- Adequate renal function (measured creatinine clearance > 50 ml/min by DTPA or 51CR-EDTA), bone marrow function (Hb > 9 g/d/L, ANC > 1.5 x109L, and platelets > 100 x 10/L);
- Adequate liver function (serum total bilirubin ≤ 1.5 x ULN, and Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP) ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver metastases)). INR ≤ 1.5 (or on a stable dose of LMW heparin for >2 weeks at time of enrolment .);
- Life expectancy of at least 9 months;
- Study treatment both planned and able to start within 28 days of randomisation; )
- Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments;
- Signed, written informed consent.
Who cannot join
- Primary NETs other than small bowel (midgut) or pancreatic NETs;
- Cytotoxic chemotherapy, targeted therapy, or biotherapy within the last four weeks;
- Prior intrahepatic 90Y microspheres, such as SIR-Spheres in the past six months;
- Prior Peptide Receptor Radionuclide Therapy;
- Major surgery/surgical therapy for any cause within one month;
- Surgical therapy of loco-regional metastases within the last three months prior to randomisation;
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- Uncontrolled metastatic disease to the central nervous system. To be eligible, CNS metastases should have been treated with surgery and/or radiotherapy and the patient should have been receiving a stable dose of steroids for at least 2 weeks prior to randomisation, with no deterioration in neurological symptoms during this time;
- Poorly controlled concurrent medical illness. E.g. unstable diabetes (Note: optimal glycaemic control should be achieved before starting trial therapy); Symptomatic NYHA class III or IV congestive cardiac failure, myocardial infarction within 6 months of start of the study, serious uncontrolled cardiac arrhythmia, unstable angina, or any other clinically significant cardiac disease;
- History of other malignancies within 5 years except where treated with curative intent AND with no current evidence of disease AND considered not to be at risk of future recurrence Patients with a past history of adequately treated carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder are eligible;
- Any uncontrolled known active infection, including chronic active hepatitis B, hepatitis C, or HIV. Testing for these is not mandatory unless clinically indicated. Participants with known Hepatitis B/C infection will be allowed to participate providing evidence of viral suppression has been documented and the patient remains on appropriate anti-viral therapy;
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of capecitabine/temozolomide (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or substantial small bowel resection);
- Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, including alcohol dependence or drug abuse;
- Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. Men must have been surgically sterilised or use a (double if required) barrier method of contraception .
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
Peter MacCallum Cancer Centre
East Melbourne, Victoria, 8006
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Royal North Shore Hospital
St Leonards, New South Wales, 2065
About this study
Two parallel phase II randomized open label trials of Lutetium-177 Octreotate (177Lu-Octreotate) peptide receptor radionuclide therapy (PRRT) and capecitabine (CAP)/temozolomide (TEM) chemotherapy (chemo): (i) versus CAPTEM alone in the treatment of low to intermediate grade pancreatic neuroendocrine tumours (pNETs); (ii) versus PRRT alone in the treatment of low to intermediate grade mid gut neuroendocrine tumours (mNETs).
Read the detailed description
PROTOCOL SYNOPSIS
Background
Neuroendocrine tumours (NETs) are a heterogeneous group of malignancies that can arise at any site in the gastrointestinal tract, that are known by their ability to over express somatostatin receptors. Originally called carcinoid tumours, these tumours are rising in incidence. In patients with incurable disease, several systemic options have demonstrated activity but few have been compared in prospective, randomised controlled trials (RCTs). 177Lu-Octreotate peptide receptor radionuclide therapy (PRRT) and CAPTEM have shown promising activity in initial single arm trials. Prospective RCTs are needed to build on these early trials to determine the optimal role of these therapies in clinical practice.
CONTROL NETs is a parallel group phase II randomised open label trial of Lutetium-177 Octreotate (177Lu-Octreotate (Lutate)) peptide receptor radionuclide therapy (PRRT) and capecitabine (CAP)/temozolomide (TEM) chemotherapy (chemotherapy): (i) versus CAPTEM alone in the treatment of low to intermediate grade pancreatic neuroendocrine tumours (pNETs); (ii) versus PRRT alone in the treatment of low to intermediate grade midgut neuroendocrine tumours (mNETs).
General aim
- To determine the relative activity of CAPTEM/PRRT in biopsy-proven, low to intermediate grade, unresectable, metastatic 68Ga-octreotate PET-avid NETs in the following parallel phase II studies: Group A: pNETs and Group B: mNETs. ii) To inform future comparative phase III RCTs to determine the optimal therapies in pNETs and mNETs.
Design
Two parallel non-comparative group randomised, controlled, multi-centre phase II, 2 arm open-label controlled trials with 2:1 allocation (experimental : control)
- Study A: pNETs: PRRT/CAPTEM vs. CAPTEM (control)
- Study B: mNETs: PRRT/CAPTEM vs. PRRT (control)
Randomisation will be performed using the method of minimisation.
Patients will be stratified by:
- Previous systemic therapy regimens (0,1 v 2)
- WHO tumour grade: Low Grade - G1 (Ki67<3% (mitotic count <2)) vs. Intermediate Grade - G2 (Ki67 3-20% (mitotic count 2-20))
- visceral only vs. visceral with bone metastases
- Treating institution
Population
The target population for this study is consenting adult patients with advanced, unresectable low or intermediate grade (Ki-67<20%) midgut neuroendocrine tumours (mNETs) or pancreatic neuroendocrine tumours (pNETs ), who have received ≤ 2 prior systemic therapies for advanced unresectable disease (including long acting somatostatin analogues).
Assessments
- Patients will be assessed at each treatment cycle for toxicity
- CT including a 3 phase contrast CT of the liver will be undertaken at baseline, then every 2 months (pNET) or every 4 months (pNET) until radiologic progression by RECIST v1.1.
- 68Ga-DOTATATE PET CT Scan will be undertaken at baseline, then every 4 months until radiologic progression by RECIST v1.1.
- 18F-FDG PET Scan may be performed at the discretion of treating clinician at baseline, then every 2 months until radiologic progression by RECIST v1.1) for G2 NETS.
- 24-h whole-body planar gamma imaging will be undertaken on the day after administration of PRRT (every 2 months).
- Serum biomarkers will be undertaken every 4 months until disease progression.
- Quality of life assessments will be undertaken at every 2 months until disease progression using QLC C30 and QLQ-GINET21.
- Health utilities will be evaluated with EQ-5D-5L every 2 months until completion of study follow up.
Statistical considerations
Both studies are based on a Simon's two-stage design and are randomised using a 2:1 randomisation (Experimental: Control). A mix of approximately 30% G1 patients and 70% G2 patients is expected.
Study A, pNETs (n=90) will have 80% power with 95% confidence interval to exclude a 12 months PFS of 60% in favour of a more interesting rate of 77% in the experimental arm.
For Study B, mNETs (n=75), the PFS at 24 months in the control arm is expected to be 52%. Thus study B will have 80% power with 95% confidence interval to demonstrate a PFS rate at 24 months of 70% in experimental arm, a result that would warrant further investigation.
A total sample size of 165 patients for the two studies will be accrued over 2 years.
Patients will be followed up for a minimum of 2 years.
- Being tested
- octreotate, Capecitabine, Temozolomide
- Keywords
- midgut, pancreatic, neuroendocrine, advanced, unresectable low, intermediate grade, mNETs, pNETs
- Medical subject headings
- Neuroectodermal Tumors, Primitive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
octreotateDrug
Also called lutate
7.8GBq 177Lu Octreotate (Lutate) given intravenously (IV)
CapecitabineDrug
Also called Xeloda
oral capecitabine 750mg/m2 b.i.d.
TemozolomideDrug
temozolomide 75mg/m2 b.i.d.
| Study group | Role | What they receive |
|---|---|---|
| PRRT | Active comparator | 7.8GBq 177Lu Octreotate (Lutate) given intravenously (IV) on day 1 every 8 weeks for 4 cycles. Receives: Drug: octreotate |
| CAPTEM | Active comparator | Oral capecitabine 750mg/m2 b.i.d. days 1-14 and temozolomide 75mg/m2 b.i.d. days 10-14 every 28 day cycle, up to 8 cycles. Receives: Drug: Capecitabine; Drug: Temozolomide |
| PRRT/CAPTEM | Experimental | 7.8GBq 177Lu Octreotate (Lutate) given intravenously (IV) on day 10 every 8 weeks for 4 cycles, with concurrent oral capecitabine 750mg/m2 b.i.d. days 1-14 and temozolomide 75mg/m2 b.i.d. days 10-14 up to 4 cycles. Receives: Drug: octreotate; Drug: Capecitabine; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
To determine the rate of progression free survival (PFS) at 12 months in pNETs (Group A), and at 24 months in mNETs (Group B). (PFS defined from time of randomisation to disease progression as defined by RECIST criteria version 1.1).
Measured: 12 months for pNETs and 24 months for mNets
Secondary outcomes (6)
Objective tumour response rate (partial or complete response) as per RECIST v1.1 criteria
To determine objective tumour response rate (OTRR) (partial or complete response (PR/CR)).
Measured: 12 months or 24 months as appropriate
Overall survival (death from any cause)
To determine overall survival (OS) (death from any cause).
Measured: 12 months or 24 months as appropriate
Safety (rates of adverse events worst grade according to NCI CTCAE v4.0)
To determine safety (rates of adverse events).
Measured: 12 months or 24 months as appropriate
Quality of life (QOL scores determined at beginning, during treatment and until disease progression)
To determine Quality of Life (QoL) (QoL scores from EORTC QLQ C30 and QLQ-GINET21 questionnaires)
Measured: 12 months or 24 months as appropriate
Resource utilisation (use of healthcare resources) and cost-effectiveness (Health utility score determined at beginning, during treatment and until end of follow up, correlated with MBS & PBS data)
To determine resource utilization (costs associated with treatment regimen, MBS and PBS data, and health utilities scores from EQ-5D-5L).
Measured: 12 months or 24 months as appropriate
Clinical Benefit
To evaluate the proportion of patients who have experienced a clinical benefit of the regimen(s). (Clinical Benefit is defined as the proportion of patients who experience complete or partial response (using RECIST v1.1) or stable disease at 12 months or 24 months as appropriate).
Measured: 12 months or 24 months as appropriate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startNov 2015
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
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 Midgut Neuroendocrine TumoursStudies 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Australasian Gastro-Intestinal Trials Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Nick Pavlakis, Associate Professor, Study chair, Royal North Shore Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358356
- Sponsor's protocol ID
- CTC0120 / AG0114NET
- Acronym
- CONTROL NETS
- Status last verified
- Nov 2017
- First submitted
- 4 Nov 2014
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chan DL, Sjoquist KM, Ransom DT, Wyld D, Wilson K, Gebski V, Murray J, Kiberu AD, Burge ME, Macdonald W, Roach P, Pattison DA, Butler P, Price TJ, Michael M, Lawrence BJ, Bailey DL, Leyden J, Leyden S, Zalcberg JR, Turner JH, Pavlakis N. [177Lu]Lu-DOTATATE PRRT and CAPTEM chemotherapy for pancreas and small bowel neuroendocrine tumours: The AGITG CONTROL NETS Multi-centre randomized trial. Eur J Cancer. 2026 Jun 18;241:116781. doi: 10.1016/j.ejca.2026.116781. Epub 2026 May 9.
PubMed 42142431
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capecitabine ON Temozolomide Radionuclide Therapy Octreotate Lutetium-177 NeuroEndocrine Tumours Study
- ClinicalTrials.gov ID
- NCT02358356
- Acronym / sponsor ID
- CONTROL NETS / CTC0120 / AG0114NET
- Keywords
- midgut, pancreatic, neuroendocrine, advanced, unresectable low, intermediate grade, mNETs, pNETs
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Australasian Gastro-Intestinal Trials GroupResearch network
- Study start
- Nov 2015
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 9 Feb 2015 (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.
Two parallel phase II randomized open label trials of Lutetium-177 Octreotate (177Lu-Octreotate) peptide receptor radionuclide therapy (PRRT) and capecitabine (CAP)/temozolomide (TEM) chemotherapy (chemo): (i) versus CAPTEM alone in the treatment of low to intermediate grade pancreatic neuroendocrine tumours (pNETs); (ii) versus PRRT alone in the treatment of low to intermediate grade mid gut neuroendocrine tumours (mNETs).
Detailed description
PROTOCOL SYNOPSIS
Background
Neuroendocrine tumours (NETs) are a heterogeneous group of malignancies that can arise at any site in the gastrointestinal tract, that are known by their ability to over express somatostatin receptors. Originally called carcinoid tumours, these tumours are rising in incidence. In patients with incurable disease, several systemic options have demonstrated activity but few have been compared in prospective, randomised controlled trials (RCTs). 177Lu-Octreotate peptide receptor radionuclide therapy (PRRT) and CAPTEM have shown promising activity in initial single arm trials. Prospective RCTs are needed to build on these early trials to determine the optimal role of these therapies in clinical practice.
CONTROL NETs is a parallel group phase II randomised open label trial of Lutetium-177 Octreotate (177Lu-Octreotate (Lutate)) peptide receptor radionuclide therapy (PRRT) and capecitabine (CAP)/temozolomide (TEM) chemotherapy (chemotherapy): (i) versus CAPTEM alone in the treatment of low to intermediate grade pancreatic neuroendocrine tumours (pNETs); (ii) versus PRRT alone in the treatment of low to intermediate grade midgut neuroendocrine tumours (mNETs).
General aim
- To determine the relative activity of CAPTEM/PRRT in biopsy-proven, low to intermediate grade, unresectable, metastatic 68Ga-octreotate PET-avid NETs in the following parallel phase II studies: Group A: pNETs and Group B: mNETs. ii) To inform future comparative phase III RCTs to determine the optimal therapies in pNETs and mNETs.
Design
Two parallel non-comparative group randomised, controlled, multi-centre phase II, 2 arm open-label controlled trials with 2:1 allocation (experimental : control)
- Study A: pNETs: PRRT/CAPTEM vs. CAPTEM (control)
- Study B: mNETs: PRRT/CAPTEM vs. PRRT (control)
Randomisation will be performed using the method of minimisation.
Patients will be stratified by:
- Previous systemic therapy regimens (0,1 v 2)
- WHO tumour grade: Low Grade - G1 (Ki67<3% (mitotic count <2)) vs. Intermediate Grade - G2 (Ki67 3-20% (mitotic count 2-20))
- visceral only vs. visceral with bone metastases
- Treating institution
Population
The target population for this study is consenting adult patients with advanced, unresectable low or intermediate grade (Ki-67<20%) midgut neuroendocrine tumours (mNETs) or pancreatic neuroendocrine tumours (pNETs ), who have received ≤ 2 prior systemic therapies for advanced unresectable disease (including long acting somatostatin analogues).
Assessments
- Patients will be assessed at each treatment cycle for toxicity
- CT including a 3 phase contrast CT of the liver will be undertaken at baseline, then every 2 months (pNET) or every 4 months (pNET) until radiologic progression by RECIST v1.1.
- 68Ga-DOTATATE PET CT Scan will be undertaken at baseline, then every 4 months until radiologic progression by RECIST v1.1.
- 18F-FDG PET Scan may be performed at the discretion of treating clinician at baseline, then every 2 months until radiologic progression by RECIST v1.1) for G2 NETS.
- 24-h whole-body planar gamma imaging will be undertaken on the day after administration of PRRT (every 2 months).
- Serum biomarkers will be undertaken every 4 months until disease progression.
- Quality of life assessments will be undertaken at every 2 months until disease progression using QLC C30 and QLQ-GINET21.
- Health utilities will be evaluated with EQ-5D-5L every 2 months until completion of study follow up.
Statistical considerations
Both studies are based on a Simon's two-stage design and are randomised using a 2:1 randomisation (Experimental: Control). A mix of approximately 30% G1 patients and 70% G2 patients is expected.
Study A, pNETs (n=90) will have 80% power with 95% confidence interval to exclude a 12 months PFS of 60% in favour of a more interesting rate of 77% in the experimental arm.
For Study B, mNETs (n=75), the PFS at 24 months in the control arm is expected to be 52%. Thus study B will have 80% power with 95% confidence interval to demonstrate a PFS rate at 24 months of 70% in experimental arm, a result that would warrant further investigation.
A total sample size of 165 patients for the two studies will be accrued over 2 years.
Patients will be followed up for a minimum of 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PRRT | Active comparator | Drug: octreotate7.8GBq 177Lu Octreotate (Lutate) given intravenously (IV) on day 1 every 8 weeks for 4 cycles. |
| CAPTEM | Active comparator | Drug: Capecitabine, Drug: TemozolomideOral capecitabine 750mg/m2 b.i.d. days 1-14 and temozolomide 75mg/m2 b.i.d. days 10-14 every 28 day cycle, up to 8 cycles. |
| PRRT/CAPTEM | Experimental | Drug: octreotate, Drug: Capecitabine, Drug: Temozolomide7.8GBq 177Lu Octreotate (Lutate) given intravenously (IV) on day 10 every 8 weeks for 4 cycles, with concurrent oral capecitabine 750mg/m2 b.i.d. days 1-14 and temozolomide 75mg/m2 b.i.d. days 10-14 up to 4 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adults ≥18 years old with histologically proven, moderate to well-differentiated G1/2 pancreatic or midgut NETs with Ki-67 < 20%;
- The presence of somatostatin receptor avidity suitable for PRRT demonstrated on 68Ga-octreotate PET scan;
- Progressive advanced/metastatic disease that has progressed during or after ≤ 2 prior systemic therapies;
- Unresectable disease, determined by an appropriately specialized surgeon or deemed not suitable for liver directed therapies where liver is the only site of disease;
- ECOG performance status 0-2;
Key exclusion criteria (13 listed)
- Primary NETs other than small bowel (midgut) or pancreatic NETs;
- Cytotoxic chemotherapy, targeted therapy, or biotherapy within the last four weeks;
- Prior intrahepatic 90Y microspheres, such as SIR-Spheres in the past six months;
- Prior Peptide Receptor Radionuclide Therapy;
- Major surgery/surgical therapy for any cause within one month;
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 |
|---|---|---|
| octreotateAlso: lutate7.8GBq 177Lu Octreotate (Lutate) given intravenously (IV) | Drug | PRRT, PRRT/CAPTEM |
| CapecitabineAlso: Xelodaoral capecitabine 750mg/m2 b.i.d. | Drug | CAPTEM, PRRT/CAPTEM |
| Temozolomidetemozolomide 75mg/m2 b.i.d. | Drug | CAPTEM, PRRT/CAPTEM |
Primary outcome
Progression Free Survival
Time frame: 12 months for pNETs and 24 months for mNets
To determine the rate of progression free survival (PFS) at 12 months in pNETs (Group A), and at 24 months in mNETs (Group B). (PFS defined from time of randomisation to disease progression as defined by RECIST criteria version 1.1).
6 secondary outcomes
Objective tumour response rate (partial or complete response) as per RECIST v1.1 criteria
Time frame: 12 months or 24 months as appropriate
Overall survival (death from any cause)
Time frame: 12 months or 24 months as appropriate
Safety (rates of adverse events worst grade according to NCI CTCAE v4.0)
Time frame: 12 months or 24 months as appropriate
Quality of life (QOL scores determined at beginning, during treatment and until disease progression)
Time frame: 12 months or 24 months as appropriate
Resource utilisation (use of healthcare resources) and cost-effectiveness (Health utility score determined at beginning, during treatment and until end of follow up, correlated with MBS & PBS data)
Time frame: 12 months or 24 months as appropriate
Clinical Benefit
Time frame: 12 months or 24 months as appropriate
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 5 Jul 2022.
- Derived from this study: PubMed 42142431Chan DL, Sjoquist KM, Ransom DT, Wyld D, Wilson K, Gebski V, Murray J, Kiberu AD, Burge ME, Macdonald W, Roach P, Pattison DA, Butler P, Price TJ, Michael M, Lawrence BJ, Bailey DL, Leyden J, Leyden S, Zalcberg JR, Turner JH, Pavlakis N. [177Lu]Lu-DOTATATE PRRT and CAPTEM chemotherapy for pancreas and small bowel neuroendocrine tumours: The AGITG CONTROL NETS Multi-centre randomized trial. Eur J Cancer. 2026 Jun 18;241:116781. doi: 10.1016/j.ejca.2026.116781. Epub 2026 May 9.
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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.
Nick Pavlakis, Associate Professor study chair
Royal North Shore Hospital
4 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 octreotate, Capecitabine and Temozolomide in people with Midgut Neuroendocrine Tumours and Pancreatic Neuroendocrine Tumours, run by Australasian Gastro-Intestinal Trials Group at 4 sites in Australia.
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 12 inclusion and 13 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 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. 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 (time frame: 12 months for pNETs and 24 months for mNets). 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 NCT02358356, 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 5 Jul 2022.