- CONTROL NETS
Trial Status
Completed
Cancer Type
NeuroEndocrine Tumours (NETs)
Protocol Title
Capecitabine ON Temozolomide Radionuclide therapy Octreotate Lutetium-177 NeuroEndocrine Tumours Study
Purpose of the Study
The aim of CONTROL NETS is to find the optimal treatment to improve disease control in patients with advanced NETs. More specifically, the purpose of the study is to determine the activity of capecitabine plus temozolomide (CAPTEM)/peptide receptor radionuclide therapy (PRRT), in combination, in both pancreatic neuroendocrine tumours (pNETS) and mid-gut (small bowel) neuroendocrine tumours (mNETS) patients.
Eligibility Criteria
Inclusion Criteria
- Adults greater than or equal to 18 years old with histologically proven pancreatic or midgut NETs
- The presence of somatostatin receptor avidity suitable for PRRT demonstrated on 68Ga-octreotate PET scan;
- Ability to swallow oral medication;
- Adequate renal function
- Adequate liver function
- 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.
Exclusion Criteria
- Primary NETs other than small bowel (midgut) or pancreatic NETs;
- Prior Peptide Receptor Radionuclide Therapy;
- Major surgery/surgical therapy for any cause within one month;
- Poorly controlled concurrent medical illness. E.g. unstable diabetes
- 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
- Any uncontrolled known active infection, including chronic active hepatitis B, hepatitis C, or HIV.
- 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.
CONTACT EMAIL
Study Chairs
Professor Nick Pavlakis
Professor J Harvey Turner
DETAILED INFORMATION AVAILABLE
Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) here
FUNDING
Unicorn Foundation
Trial Status
Completed
Cancer Type
NeuroEndocrine Tumours (NETs)
Protocol Title
“Capecitabine ON Temozolomide Radionuclide therapy Octreotate Lutetium-177 NeuroEndocrine Tumours Study”
Publication Reference
None to date
Conference Presentation Reference
None to date
Aim
The aim of CONTROL NETS is to find the optimal treatment to improve disease control in patients with advanced NETs. More specifically, the purpose of the study is to determine the activity of capecitabine plus temozolomide (CAPTEM)/peptide receptor radionuclide therapy (PRRT), in combination, in both pancreatic neuroendocrine tumours (pNETS) and mid-gut (small bowel) neuroendocrine tumours (mNETS) patients.
Background
Neuroendocrine tumours (NETs) that have metastasised or cannot be removed by surgery are incurable with currently available treatments. Standard therapies to help manage advanced NET and to improve survival in patients include chemotherapy, hormone treatment and radioactive (“radiopeptide”) treatments to help with the numerous and varies symptoms. Many patients will need to use more than one of these types of treatments for their cancer. However, there are still many questions about the best way of using these, and newer treatments, to help patients, particularly as some treatments have only been studied in small groups of patients.
CONTROL NETs aims to assess whether the combination of chemotherapy with CAPTEM, combined with radiopeptide treatment (PRRT: LuTate) evaluated in parallel in small bowel and pancreatic NETs, has sufficient activity to be subsequently explored in a Phase III trial. A control reference arm will be used in each tumour group as a calibration arm to ensure the assumptions, upon which the statistical plan is based, were accurate. These control arms are: CAPTEM alone (in pancreatic NET group) and LuTate alone (in mid-gut NET group).
All the treatments used in this trial have been looked at before in earlier trials. They have shown activity against this type of cancer but there is no comparative data.
The results will also help inform the design of larger, future clinical trials aimed at determining the best treatment for these diseases.
CLINICAL TRIAL DESIGN
CONTROL NETS is a Phase II, randomised, parallel group, multicentre trial.
Eligible participants will be entered into their respective study (by tumour type) then randomized to receive
- CAPTEM/LuTate combination or CAPTEM chemotherapy alone (pancreatic NETs)
- CAPTEM/LuTate combination or LuTate alone (small bowel NETs).
Combination chemotherapy (CAPTEM) involves taking 2 different types of tablets – capecitabine, given twice a day for 14 days, and temozolomide, given daily for 5 days – every 4 weeks. This treatment continues for 6 to 8 cycles (about 5 to 7 months). Patients who are randomised to chemotherapy alone and then have progressive disease will be able to access the radiopeptide treatment at that time.
Radiopeptide treatment (LuTate) involves receiving treatment intravenously once every 8 weeks, for a total of 4 treatments (about 6 months). Patients are given fluids through the drip as well for 4 hours to help protect their kidneys from any potential damage.
Patients in the CAPTEM chemotherapy plus LuTate arm will receive the same radiopeptide treatment, plus the combination chemotherapy every 8 weeks. 4 cycles will be given in total (about 6 months).
Treatment for all groups will continue for 32 weeks. Study participants will be required to visit the clinic, between 9 to 12 times during the treatment stage, depending on which treatment they receive. The visits will vary in length between 2 and 6 hours.
Afterwards, there will be 12 months of follow-up for pancreatic neuroendocrine tumour patients and 24 months for small bowel neuroendocrine tumour patients.
Contact Email
controlnets@ctc.usyd.edu.auPrincipal Investigator
Associate Prof. Nick Pavlakis
More Information
Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) here
Funding
Unicorn Foundation