A randomised phase II study comparing capecitabine plus streptozocin with or without cisplatin in the treatment of unresectable or metastatic gastroentero-neuroendocrine tumours of the foregut, pancreatic neuroendocrine tumours and neuroendocrine tumours of unknown primary site

ISRCTN	ISRCTN35124268
DOI	https://doi.org/10.1186/ISRCTN35124268
ClinicalTrials.gov (NCT)	NCT00602082
Clinical Trials Information System (CTIS)	2004-005202-71
Protocol serial number	N/A
Sponsor	Cambridge University Hospitals NHS Foundation Trust (UK)
Funders	Addenbrookes Hospital Oncology Centre (UK) - costs of trial administration, University of Glasgow Pathology Department (UK) - pathological study costs

Submission date: 09/12/2005
Registration date: 06/02/2006
Last edited: 19/10/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerhelp.org.uk/trials/a-trial-looking-at-chemotherapy-for-neuroendocrine-tumours-that-have-spread-or-cant-be-removed-with-an-operation

Contact information

Dr Pippa Corrie
Scientific

Oncology Centre
Box 193
Addenbrookes Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Phone	+44 (0)1223 274376
Email	pippa.corrie@addenbrookes.nhs.uk

Study information

Primary study design	Interventional
Study design	Interventional, randomised controlled trial, phase II trial
Secondary study design	Randomised controlled trial
Scientific title	A randomised phase II study comparing capecitabine plus streptozocin with or without cisplatin in the treatment of unresectable or metastatic gastroentero-neuroendocrine tumours of the foregut, pancreatic neuroendocrine tumours and neuroendocrine tumours of unknown primary site
Study acronym	NET 01
Study objectives	What are the objective response rates of two chemotherapy regimens being tested in patients with unresectable or metastatic NeuroEndocrine Tumours (NET) originating from the stomach, duodenum, pancreas or from an unknown primary site?
Ethics approval(s)	South West MREC on 23/08/2005 (ref: 05/MRE06/32)
Health condition(s) or problem(s) studied	Neuroendocrine tumour
Intervention	Patients will be randomised to one of two groups: 1. Streptozocin (Zanosar) injection on the first day of every three week cycle 2. Streptozocin (Zanosar) and cisplatin injections on the first day of each three week cycle Each patient will have up to six cycles of chemotherapy treatment over 18 weeks. One treatment cycle will last three weeks (21 days). Both groups will also be taking capecitabine (Xeloda) tablets continuously, twice a day, for 18 weeks. Patients will be asked to fill in a quality of life questionnaire before they start treatment, every nine weeks during the treatment and 12 weeks after the last treatment. Patients will also have CT and MRI scans every three cycles (nine weeks) while they are having the treatment.
Intervention type	Drug
Phase	Phase II
Drug / device / biological / vaccine name(s)	Streptozocin, cisplatin, capecitabine
Primary outcome measure(s)	Objective response rate.
Key secondary outcome measure(s)	1. Overall response rate, to include both objective and biochemical responses 2. Functional response 3. Toxicity of both combination regimens 4. To identify the optimal drug doses in each regimen to be recommended for a subsequent phase III trial 5. Progression-free survival 6. Overall survival 7. Quality of life 8. Molecular markers predictive of response to chemotherapy
Completion date	31/05/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	84
Key inclusion criteria	1. Patients with histological confirmation of resectable, advanced and/or metastatic: 1.1. Gastroentero-neuroendocrine tumour of the foregut 1.2. Pancreatic neuroendocrine tumour 1.3. Neuroendocrine tumour of unknown primary source 2. Measureable disease, defined by the presence of at least one lesion which can be accurately measured in at least one dimension with longest diameter more than 20 mm using conventional Computed Tomography (CT) scanning, or more than 10 mm with spiral CT or Magnetic Resonance Imaging (MRI) 3. No prior or concomitant chemotherapy or immunotherapy administered for this condition 4. Life expectancy more than 12 weeks 5. Performance status zero, one or two (Eastern Cooperative Oncology Group [ECOG] performance scale) 6. Aged over 18 years
Key exclusion criteria	1. Bronchial NETs 2. No previous systemic chemotherapy or chemotherapy administered as part of a chemo-embolisation regimen is allowed. Prior interferon is allowed. In this case, the time interval between the last dose of interferon and the date of commencing chemotherapy within this trial should be at least three weeks 3. Any previous investigational agent within the last four weeks. Patients may have previously received somatostatin analogues. Patients on somatostatin analogues are eligible to enter the study if their symptoms are no longer controlled by this treatment or there is documented measurable disease progression on serial CT scans performed up to six months apart, as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria. At the time of trial entry, it is acceptable for the patient to continue their somatostatin analogue therapy or to stop it, depending on individual circumstances 4. Palliative radiotherapy involving any of the lesion(s) being used to measure disease. Palliative radiotherapy to regions not involved in measurement of disease is permitted. 5. Any other serious or uncontrolled illness, which in the opinion of the investigator, makes it undesirable for the patient to enter the trial 6. Any medical or psychiatric condition which would influence the ability to provide informed consent 7. Pregnant or lactating women
Date of first enrolment	01/06/2005
Date of final enrolment	31/05/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Oncology Centre

Cambridge
CB2 2QQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2014		Yes	No
Plain English results				No	Yes

Editorial Notes

19/10/2018: Cancer Research UK lay results summary link added to Results (plain English)