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Tests treatment safety and results for Carcinoma, Neuroendocrine
Official title A Trial to Assess the Safety and Effectiveness of Lutetium-177 Octreotate Therapy in Neuroendocrine Tumours
ClinicalTrials.gov ID: NCT01876771
What this study is testing
What is [177]Lu-DOTA-TATE?
[177]Lu-DOTA-TATE is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for carcinoma, neuroendocrine.
Also referred to as Lu-DOTA-TATE.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Neuroendocrine tumours (NETs) are rare, slow growing, and diagnosis is often delayed with advanced metastases at presentation. In select patient populations, radioisotope therapy with Lutetium-177 (Lu-DOTA-TATE) has been shown to be a safe and effective palliative therapy, and has been widely used by research groups in Europe.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 90
You may be able to join if
- Group A (Primary Therapy)
- Male or female ≥ 14 - 90 years of age.
- At least 1 tumour site reliably evaluable by CT or magnetic resonance imaging (MRI) of at least 1.0 cm (smallest dimension) or ≥ 1.5 cm lymph node...
- Histologically confirmed diagnosis of neuroendocrine tumor.
- Progressive disease documented by anatomic imaging and/or presence of new lesions on somatostatin receptor imaging assessed by comparable studies. In...
You likely can't join if
- Have previously received Lu-DOTA-TATE therapy.
- Potential for surgery with curative intent. Local surgery for symptomatic relief permitted as long as target lesion unaffected.
- Major surgery within 12 weeks of enrolment. Minor surgeries such as removal of superficial skin lesions, laser eye surgery, cataract surgery...
- Liver embolization [transcatheter arterial embolization (TAE), TACE, or TARE] within 4 weeks of enrolment.
- Radioisotope therapy within 12 weeks of enrolment.
- Systemic therapy: mTOR inhibitors and tyrosine kinase inhibitors within 6 weeks of enrolment; chemotherapy and interferon within 8 weeks of enrolment.
See the full eligibility criteria
- Group A (Primary Therapy)
- Male or female ≥ 14 - 90 years of age.
- At least 1 tumour site reliably evaluable by CT or magnetic resonance imaging (MRI) of at least 1.0 cm (smallest dimension) or ≥ 1.5 cm lymph node disease (smallest dimension) (the target lesion) within 26 weeks of...
- Histologically confirmed diagnosis of neuroendocrine tumor.
- Progressive disease documented by anatomic imaging and/or presence of new lesions on somatostatin receptor imaging assessed by comparable studies. In the opinion of the investigator, patients with no progression on...
- 18F-FDG PET/CT whole-body imaging within 26 weeks of enrolment.
- Life expectancy greater than 12 weeks from enrollment.
- Serum creatinine ≤ 150 µmol/L, and a calculated (Cockcroft-Gault) or estimated GFR of ≥ 50 mL/min measured within 2 weeks of enrollment.
- Haemoglobin concentration ≥ 90 g/L; white blood cell (WBC) count ≥ 2 x 10\^9/L; platelets ≥ 100 x 10\^9/L measured within 2 weeks of enrolment.
- Liver function tests (total bilirubin, alanine transaminase (ALT), aspartate transaminase (AST)) ≤ 3X the limit of normal measured within 2 weeks of enrolment. Serum albumin ≥ 23 g/L within 2 weeks of enrolment.
- Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 2 measured within 2 weeks of enrolment.
- Provide written informed consent prior to enrolment. Group B (Maintenance Therapy)
- Male or female ≥ 14 - 90 years of age.
- Have previously received Lu-DOTA-TATE treatment under the SAP.
- Life expectancy greater than 12 weeks from enrolment.
- Serum creatinine ≤ 150 μmol/L, and a calculated (Cockcroft-Gault) or estimated glomerular filtration rate (GFR) of ≥ 50 mL/min measured within 2 weeks of enrolment.
- Haemoglobin concentration ≥ 90 g/L; white blood cell (WBC) count ≥ 2 x 10\^9/L; platelets ≥ 100 x 10\^9/L measured within 2 weeks of enrolment.
- Liver function tests (total bilirubin, alanine transaminase (ALT), aspartate transaminase (AST)) ≤ 3X the limit of normal measured within 2 weeks of enrolment. Serum albumin ≥ 23 g/L within 2 weeks of enrolment.
- Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 2 measured within 2 weeks of enrolment.
- Provide written informed consent prior to enrolment. Group A (Primary Therapy)
- Have previously received Lu-DOTA-TATE therapy.
- Potential for surgery with curative intent. Local surgery for symptomatic relief permitted as long as target lesion unaffected.
- Major surgery within 12 weeks of enrolment. Minor surgeries such as removal of superficial skin lesions, laser eye surgery, cataract surgery, laparoscopic procedures and other procedures that are minimally invasive are...
- Liver embolization [transcatheter arterial embolization (TAE), TACE, or TARE] within 4 weeks of enrolment.
- Radioisotope therapy within 12 weeks of enrolment.
- Systemic therapy: mTOR inhibitors and tyrosine kinase inhibitors within 6 weeks of enrolment; chemotherapy and interferon within 8 weeks of enrolment.
- Change in long-acting somatostatin analogues, dosage, or dosage frequency within 12 weeks of enrolment unless changes are required to manage uncontrolled symptoms.
- Localized external beam irradiation with target lesion(s) in the radiation field. Other localized external beam therapy is permitted.
- Known brain metastases unless these metastases have been treated and stabilized (confirmed by CT) for ≥ 4 months prior to enrolment
- Uncontrolled diabetes mellitus defined as random glucose ≥ 2X the upper limit of normal (or HbA1c \> 10%, if results available) within 12 weeks of enrolment.
- Another significant medical, psychiatric or surgical condition uncontrolled by treatment, which may interfere with completion or conduct of the study (such as urinary incontinence, co-existing malignancies).
- Pregnancy.
- Breast feeding.
- Prior radiation therapy to more than 25% of the bone marrow.
- If, in the opinion of the investigator, other treatments are considered more appropriate than the investigational therapy, based on patient and disease characteristics.
- Known allergy to somatostatin analogues or any components of the study medication. Group B (Maintenance Therapy) Exclusion Criteria:
- Another significant medical, psychiatric or surgical condition uncontrolled by treatment, which may interfere with completion or conduct of the study (such as urinary incontinence or co-existing malignancies).
- Pregnancy.
- Breast feeding.
- Known allergy to somatostatin analogues or any components of the study medication.
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.