Condition category
Cancer
Date applied
07/03/2007
Date assigned
07/03/2007
Last edited
07/03/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.prrt.nl

Contact information

Type

Scientific

Primary contact

Dr M van Essen

ORCID ID

Contact details

Erasmus Medical Centre
Dr Molewaterplein 40
Rotterdam
3015 GD
Netherlands
+31 (0)10 463 5963
d.j.kwekkeboom@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Chemosensitisation with capecitabine improves the percentage of patients with objective tumour responses who are also treated with [177Lu-DOTA0,Tyr3]octreotate.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised, active controlled, parallel group, multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Neuroendocrine gastro-entero-pancreatic tumours

Intervention

Arm one: Treatment with the radioactive somatostatin analogue [177Lu-DOTA0,Tyr3]octreotate
Arm two: Treatment with [177Lu-DOTA0,Tyr3]octreotate and capecitabine

Intervention type

Drug

Phase

Not Specified

Drug names

[177Lu-DOTA0,Tyr3]octreotate

Primary outcome measures

Efficacy and safety assessments:
Objective response as determined by SWOG criteria is the main efficacy endpoint. Upon entry, subjects must have at least one measurable site of disease based on the SWOG response criteria. All lesions must be identified at baseline by physical exam, CT or Magnetic Resonance Imaging (MRI) within two months prior to the start of treatment. Changes from baseline will be assessed six weeks after the last treatment, and three, six, and 12 months after the last treatment, and then every six months, until progression occurs. Patients who discontinue early due to clinical disease progression (unsatisfactory therapeutic effect) do not require a tumour assessment.

The overall survival of patients treated with radio-labelled somatostatin analogue will be calculated from the first day of treatment until the day of death. In patients who change to other anti-tumour treatments or who are lost to follow-up censored survival will be determined by the last regular visit. The time to progression is calculated from the first day of treatment to the day of documented progression.

Tumour Assessment/SWOG:
For CT imaging at entry, a triphasic, contrast enhanced study should be performed with a slice distance of 5 or 8 mm, and continuous slices. For follow-up CT imaging, triphasic imaging is not mandatory: the imaging phase at which the lesions are best recognised can be repeated instead.

Tumour response will be recorded according to the SWOG criteria by the investigators. Bidimensional tumour measurements from CT or MRI scans that were performed before treatment enrolment and after completing the therapy will be recorded.

End of Study:
The completion of the last day of the last study period or the date and reasons of premature discontinuation from the study will be recorded. End-point of the follow-up period is disease progression or death. The follow-up may be ended five years after the conclusion of treatment. However, in all patients the collection of toxicity data (haematology, renal function) should be continued either by the investigator, referring physician, or general practitioner.

Survival Information:
Information regarding the status of the patient, date of last contact or date of death will be collected.

Secondary outcome measures

1. Changes in serum chromogranin-A concentrations
2. Safety of treatment as measured by the rate of adverse events and the monitoring of selected laboratory evaluations
3. Effect of the different treatment arms on Quality of Life as measured by the EORTC QLQ-C30 questionnaire
4. Effects on Tumour Growth Rate (TGR)

Overall trial start date

01/03/2007

Overall trial end date

01/03/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Presence of histology proven Gastro-Entero-Pancreatic (GEP) tumour(s), including bronchial carcinoids
2. Presence of somatostatin-receptors on the known tumour lesions demonstrated by OctreoScan® within six months of the first dose of radio-labelled octreotate/octreotide. The uptake on the OctreoScan® should be at least as high as normal liver uptake on planar imaging
3. Life expectancy greater than 12 weeks
4. Serum creatinine less than than 150 µmol/litre or 1.7 mg/dL, and a measured creatinine clearance (or measured Glomerular Filtration Rate [GFR] using plasma clearance methods, not gamma-camera based) of greater than or equal to 50 mL/min
5. Haemoglobin (Hgb) concentration greater than or equal to 5.5 mmol/L (greater than or equal to 8.9 g/dL); White Blood Cells (WBC) greater than or equal to 2 x 10^9/L (2000/mm^3); platelets greater than or equal to 100 x 10^9/L (100 x 10^3/mm^3)
6. Total bilirubin less than 3 x Upper Limit of Normal (ULN)
7. Serum albumin less than 30 g/L, or serum albumin greater than or equal to 30 g/L but normal prothrombin time
8. Karnofsky Performance Status greater than or equal to 60
9. Presence of at least one measurable site of disease
10. Patient’s written voluntary informed consent to participate in the study, obtained prior to enrolment into the study. The informed consent must be maintained in the investigator's study files

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

200

Participant exclusion criteria

1. Possible surgery with curative intent
2. Surgery, radiotherapy, chemotherapy, or other investigational therapy within three months of the start of therapy
3. Patients with known brain metastases unless these metastases have been treated and stabilised for at least six months prior to study start. Patients with a history of brain metastases must have a head Computed Tomography (CT) with contrast to document stable disease prior to study start
4. Uncontrolled congestive heart failure
5. Any subject who is taking concomitant medications which decrease renal function (such as aminoglycoside antibiotics)
6. Any subject receiving therapy with somatostatin analogues, unless the dose has been stable for at least three months prior to the first cycle in this study and the disease status during these three months has been documented by South West Oncology Group (SWOG) criteria as described in this study
7. Any subject receiving therapy with short-acting somatostatin analogues in whom these analogues cannot be interrupted for 12 hours before and 12 hours after the administration of the radio-labelled somatostatin analogues, or any subject receiving therapy with long-acting somatostatin analogues in whom these analogues cannot be interrupted for at least six weeks before the administration of the radio-labelled somatostatin analogues, unless the uptake on the OctreoScan® during continued somatostatin analogue medication is at least as high as normal liver uptake on planar imaging
8. In patients with unusual haematological parameters, including an increased Mean red Cell Volume (MCV) (greater than 105 fL), and especially in those who had previous chemotherapy, the advice of a haematologist should be sought, for adequate further work-up
9. Subjects with another significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study
10. Pregnancy
11. Prior radiation therapy to more than 25% of the bone marrow

Recruitment start date

01/03/2007

Recruitment end date

01/03/2010

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Centre
Rotterdam
3015 GD
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (The Netherlands)

Sponsor details

Department of Nuclear Medicine
Rotterdam
3015 GJ
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.erasmusmc.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Erasmus Medical Centre (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes