Neuroendocrine (NE) TumorsPhase 2NCT07012330
Comparing 177Lu-Dotatate/Capecitabine Combination Treatment With 177Lu-Dotatate in Neuroendocrine Tumor Patients
A Phase 2 study testing Capecitabine (Xeloda) and 177Lu-DOTATATE in people with Neuroendocrine (NE) Tumors, run by Erasmus Medical Center.
Trial summary
Peptide receptor radionuclide therapy (PRRT) with [177Lu]Lu-[DOTA0,Tyr3]octreotate (177Lu-Dotatate) is an effective and safe treatment for patients with metastatic gastroenteropancreatic neuroendocrine tumors (GEP NET). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine (NE) Tumors
- What is being tested?
- Capecitabine (Xeloda) and 177Lu-DOTATATE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2007to 31 Dec 2015
- 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
- Presence of histology proven GEP tumor(s), including bronchial carcinoids.
- Presence of somatostatin-receptors on the known tumor lesions demonstrated by OctreoScan® within 6 months of the first dose of radiolabelled octreotate/octreotide. The uptake on the octreoscan should be at least as high as normal liver uptake on planar imaging.
- Life expectancy greater than 12 weeks
- Serum creatinine ≤150 μmol/liter or 1.7 mg/dL, and a measured creatinine clearance (or measured GFR using plasma clearance methods, not gamma-camera based) of ≥50 mL/min.
- Hemoglobin (Hgb) concentration ≥5.5 mmol/L (≥8.9 g/dL); WBC ≥ 2*109/L (2000/mm3); platelets ≥ 100*109/L (100*103/mm3).
- Total bilirubin ≤3 x ULN.
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- Serum albumin > 30 g/L, or serum albumin ≤ 30 g/L but normal prothrombin time.
- Karnofsky Performance Status ≥ 60.
- Presence of at least 1 measurable site of disease.
- Patient's written voluntary informed consent to participate in the study, obtained prior to enrollment into the study. The informed consent must be maintained in the investigator's study files.
Who cannot join
- Possible surgery with curative intent.
- Surgery, radiotherapy, chemotherapy, or other investigational therapy within 3 months of the start of therapy.
- Patients with known brain metastases unless these metastases have been treated and stabilized for at least six months prior to study start. Patients with a history of brain metastases must have a head CT with contrast to document stable disease prior to study start.
- Uncontrolled congestive heart failure.
- Any subject who is taking concomitant medications which decrease renal function (such as aminoglycoside antibiotics).
- Any subject receiving therapy with somatostatin analogues, unless the dose has been stable for at least 3 months prior to the first cycle in this study and the disease status during these 3 months has been documented by SWOG criteria as described in this study.
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- 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 radiolabelled somatostatin analogues, or any subject receiving therapy with long-acting somatostatin analogues in whom these analogues cannot be interrupted for at least 6 weeks before the administration of the radiolabelled 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.
- In patients with unusual hematological parameters, including an increased MCV (>105 fL), and especially in those who had previous chemotherapy, the advice of a hematologist should be seeked, for adequate further work-up.
- Subjects with another significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study.
- Pregnancy.
- Prior radiation therapy to more than 25% of the bone marrow.
About this study
Official title: A Multicenter Phase II Randomized Controlled Trial Comparing 177Lu-Dotatate/Capecitabine Combination Treatment With 177Lu-Dotatate in Neuroendocrine Tumor Patients
Peptide receptor radionuclide therapy (PRRT) with [177Lu]Lu-[DOTA0,Tyr3]octreotate (177Lu-Dotatate) is an effective and safe treatment for patients with metastatic gastroenteropancreatic neuroendocrine tumors (GEP NET). While 177Lu-Dotatate prolongs progression-free survival (PFS) and preserves quality of life (QoL), objective response rates (ORR) remain limited. Capecitabine, as radiosensitizer, could increase efficacy without increasing 177Lu-Dotatate activity. This phase II randomized controlled trial investigated the additional cytotoxic or radiosensitizing effect of capecitabine in combination with 177Lu-Dotatate.
Patients with advanced somatostatin receptor positive GEP NET or bronchopulmonary NET were included to receive four cycles of 7.4 GBq 177Lu-Dotatate and capecitabine or 177Lu-Dotatate alone. Capecitabine (1650 mg/m2/day) was administered for two weeks from the start of each PRRT cycle. Primary endpoints were ORR, PFS and median overall survival (OS). Secondary endpoints included biochemical response, adverse events and QoL.
- Conditions
- Neuroendocrine (NE) Tumors
- Being tested
- Capecitabine (Xeloda), 177Lu-DOTATATE
- Keywords
- neuroendocrine tumor, peptide receptor radionuclide therapy, capecitabine, RCT
- Medical subject headings
- Neoplasms, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine (Xeloda)Drug
Capecitabine (1650 mg/m2/day) was administered for two weeks from the start of each PRRT cycle.
177Lu-DOTATATEDrug
Patients with advanced somatostatin receptor positive GEP NET or bronchopulmonary NET were included to receive four cycles of 7.4 GBq 177Lu-Dotatate.
| Study group | Role | What they receive |
|---|---|---|
| 177Lu-Dotatate and capecitabine | Experimental | Patients with advanced somatostatin receptor positive gastroenteropancreatic (GEP) neuroendocrine tumors (NET) or bronchopulmonary NET were included to receive four cycles of 7.4 GBq 177Lu-Dotatate and capecitabine (1650 mg/m2/day) was administered for two weeks from the start of each peptide receptor radionuclide therapy (PRRT) cycle. Receives: Drug: Capecitabine (Xeloda); Drug: 177Lu-DOTATATE |
| 177Lu-Dotatate | Active comparator | Patients with advanced somatostatin receptor positive gastroenteropancreatic (GEP) neuroendocrine tumore (NET) or bronchopulmonary NET were included to receive four cycles of 7.4 GBq 177Lu-Dotatate. Receives: Drug: 177Lu-DOTATATE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rates
Radiological assessment
Measured: from enrollment until 2 years after treatment
Progression-free survival
Radiological assessment
Measured: from enrollment until 2 years after treatment
Overall survival
Measured: from enrollment until 2 years after treatment
Secondary outcomes (3)
Biochemical response
Chromogranin A and alkaline phosphatase in the blood
Measured: from enrollment until 2 years after treatment
Adverse events
Incidence and severity of adverse events according to CTCAE v5.0
Measured: from enrollment until 2 years after treatment
Quality of life, Questioner
EORTC QLQ-30
Measured: from enrollment until 2 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start1 Mar 2007
- Primary completion31 Dec 2013
- Study completion31 Dec 2015
Why it stopped: the number of dropouts and slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine (NE) TumorsStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morticia N. Becx, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012330
- Sponsor's protocol ID
- MEC-2005-266
- Status last verified
- May 2025
- First submitted
- 22 May 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase II Randomized Controlled Trial Comparing 177Lu-Dotatate/Capecitabine Combination Treatment With 177Lu-Dotatate in Neuroendocrine Tumor Patients
- ClinicalTrials.gov ID
- NCT07012330
- Acronym / sponsor ID
- MEC-2005-266
- Conditions
- Neuroendocrine (NE) Tumors
- Keywords
- neuroendocrine tumor, peptide receptor radionuclide therapy, capecitabine, RCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the number of dropouts and slow recruitment
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2007 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 10 Jun 2025 (actual)
- 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.
Peptide receptor radionuclide therapy (PRRT) with [177Lu]Lu-[DOTA0,Tyr3]octreotate (177Lu-Dotatate) is an effective and safe treatment for patients with metastatic gastroenteropancreatic neuroendocrine tumors (GEP NET). While 177Lu-Dotatate prolongs progression-free survival (PFS) and preserves quality of life (QoL), objective response rates (ORR) remain limited. Capecitabine, as radiosensitizer, could increase efficacy without increasing 177Lu-Dotatate activity. This phase II randomized controlled trial investigated the additional cytotoxic or radiosensitizing effect of capecitabine in combination with 177Lu-Dotatate.
Patients with advanced somatostatin receptor positive GEP NET or bronchopulmonary NET were included to receive four cycles of 7.4 GBq 177Lu-Dotatate and capecitabine or 177Lu-Dotatate alone. Capecitabine (1650 mg/m2/day) was administered for two weeks from the start of each PRRT cycle. Primary endpoints were ORR, PFS and median overall survival (OS). Secondary endpoints included biochemical response, adverse events and QoL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 177Lu-Dotatate and capecitabine | Experimental | Drug: Capecitabine (Xeloda), Drug: 177Lu-DOTATATEPatients with advanced somatostatin receptor positive gastroenteropancreatic (GEP) neuroendocrine tumors (NET) or bronchopulmonary NET were included to receive four cycles of 7.4 GBq 177Lu-Dotatate and capecitabine (1650 mg/m2/day) was administered for two weeks from the start of each peptide receptor radionuclide therapy (PRRT) cycle. |
| 177Lu-Dotatate | Active comparator | Drug: 177Lu-DOTATATEPatients with advanced somatostatin receptor positive gastroenteropancreatic (GEP) neuroendocrine tumore (NET) or bronchopulmonary NET were included to receive four cycles of 7.4 GBq 177Lu-Dotatate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Presence of histology proven GEP tumor(s), including bronchial carcinoids.
- Presence of somatostatin-receptors on the known tumor lesions demonstrated by OctreoScan® within 6 months of the first dose of radiolabelled octreotate/octreotide. The uptake on the octreoscan should be at least as high as normal liver uptake on planar imaging.
- Life expectancy greater than 12 weeks
- Serum creatinine ≤150 μmol/liter or 1.7 mg/dL, and a measured creatinine clearance (or measured GFR using plasma clearance methods, not gamma-camera based) of ≥50 mL/min.
- Hemoglobin (Hgb) concentration ≥5.5 mmol/L (≥8.9 g/dL); WBC ≥ 2*109/L (2000/mm3); platelets ≥ 100*109/L (100*103/mm3).
Key exclusion criteria (11 listed)
- Possible surgery with curative intent.
- Surgery, radiotherapy, chemotherapy, or other investigational therapy within 3 months of the start of therapy.
- Patients with known brain metastases unless these metastases have been treated and stabilized for at least six months prior to study start. Patients with a history of brain metastases must have a head CT with contrast to document stable disease prior to study start.
- Uncontrolled congestive heart failure.
- Any subject who is taking concomitant medications which decrease renal function (such as aminoglycoside antibiotics).
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 (Xeloda)Capecitabine (1650 mg/m2/day) was administered for two weeks from the start of each PRRT cycle. | Drug | 177Lu-Dotatate and capecitabine |
| 177Lu-DOTATATEPatients with advanced somatostatin receptor positive GEP NET or bronchopulmonary NET were included to receive four cycles of 7.4 GBq 177Lu-Dotatate. | Drug | 177Lu-Dotatate, 177Lu-Dotatate and capecitabine |
Primary outcome
Objective response rates
Time frame: from enrollment until 2 years after treatment
Radiological assessment
Progression-free survival
Time frame: from enrollment until 2 years after treatment
Radiological assessment
Overall survival
Time frame: from enrollment until 2 years after treatment
3 secondary outcomes
Biochemical response
Time frame: from enrollment until 2 years after treatment
Adverse events
Time frame: from enrollment until 2 years after treatment
Quality of life, Questioner
Time frame: from enrollment until 2 years after treatment
Results and safety
The study was stopped early (reason given: the number of dropouts and slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capecitabine (Xeloda) and 177Lu-DOTATATE in people with Neuroendocrine (NE) Tumors, run by Erasmus Medical Center.
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 10 inclusion and 11 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: stopped early, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: the number of dropouts and slow recruitment). Results are not available in the source record.
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?
Objective response rates (time frame: from enrollment until 2 years after treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2025.