A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours (NETTER-1)
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| ClinicalTrials.gov Identifier: NCT01578239 |
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Recruitment Status :
Active, not recruiting
First Posted : April 16, 2012
Results First Posted : October 2, 2017
Last Update Posted : January 21, 2020
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Sponsor:
Advanced Accelerator Applications
Information provided by (Responsible Party):
Advanced Accelerator Applications
- Study Details
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Conditions |
Carcinoid Tumor of the Small Bowel Neuroendocrine Tumour |
| Interventions |
Drug: Octreotide LAR Drug: 177Lu-DOTA0-Tyr3-Octreotate |
| Enrollment | 231 |
Participant Flow
| Recruitment Details | Overall Study Table includes all subjects who were enrolled prior to the primary endpoint data cutoff when 74 events of progression free survival were reached (24 July 2015). |
| Pre-assignment Details |
| Arm/Group Title | 177Lu-DOTA0-Tyr3-Octreotate | Octreotide LAR |
|---|---|---|
 Arm/Group Description |
Cumulative dose of 29.6 GBq (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate delivered over 4 doses Dosing regimen: - 4 doses of 7.4 GBq (200 mCi) 177Lu-DOTA0-Tyr3-Octreotate administered in 8±1-week intervals. Intervals could be extended up to 16 weeks to accommodate resolving acute toxicity (see Dose Modifying Toxicity (DMT) below) - amino acids will be given with each administration for kidney protection; Patients experiencing clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, were given 30 mg Octreotide LAR s.c. rescue injections for symptom control purpose, unless the patient progresses or dies. | 60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the patient progresses or dies (see Dose Modifying Toxicity (DMT)); In case patients experience clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections are allowed. |
| Period Title: Overall Study | ||
| Started | 116 | 113 |
| Completed | 94 | 88 |
| Not Completed | 22 | 25 |
Baseline Characteristics
| Arm/Group Title | 177Lu-DOTA0-Tyr3-Octreotate | Octreotide LAR | Total | |
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Arm/Group Description |
Cumulative dose of 29.6 GBq (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate delivered over 4 doses Dosing regimen: - 4 doses of 7.4 GBq (200 mCi) 177Lu-DOTA0-Tyr3-Octreotate administered in 8±1-week intervals. Intervals could be extended up to 16 weeks to accommodate resolving acute toxicity (see Dose Modifying Toxicity (DMT) below) - amino acids will be given with each administration for kidney protection; Patients experiencing clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, were given 30 mg Octreotide LAR s.c. rescue injections for symptom control purpose, unless the patient progresses or dies. | 60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the patient progresses or dies (see Dose Modifying Toxicity (DMT)); In case patients experience clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections are allowed. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 116 | 113 | 229 | |
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Baseline Analysis Population Description |
All patients who were randomized in the study.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 116 participants | 113 participants | 229 participants | |
| 63.3 (9.4) | 64.1 (9.7) | 63.7 (9.53) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 116 participants | 113 participants | 229 participants | |
| Female |
53 45.7%
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60 53.1%
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113 49.3%
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| Male |
63 54.3%
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53 46.9%
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116 50.7%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 116 participants | 113 participants | 229 participants |
| Belgium |
4 3.4%
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2 1.8%
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6 2.6%
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| United States |
66 56.9%
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69 61.1%
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135 59.0%
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| Italy |
5 4.3%
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9 8.0%
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14 6.1%
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| United Kingdom |
13 11.2%
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11 9.7%
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24 10.5%
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| France |
12 10.3%
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9 8.0%
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21 9.2%
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| Portugal |
1 0.9%
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0 0.0%
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1 0.4%
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| Germany |
10 8.6%
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7 6.2%
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17 7.4%
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| Spain |
5 4.3%
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6 5.3%
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11 4.8%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Paola Santoro, Ph.D., Senior Clinical Study Manager |
| Organization: | Advanced Accelerator Applications |
| Phone: | 917-854-1313 |
| EMail: | paola.santoro@adacap.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Advanced Accelerator Applications |
| ClinicalTrials.gov Identifier: | NCT01578239 |
| Other Study ID Numbers: |
AAA-III-01 2011-005049-11 ( EudraCT Number ) CAAA601A12301 ( Other Identifier: Novartis ) |
| First Submitted: | April 10, 2012 |
| First Posted: | April 16, 2012 |
| Results First Submitted: | August 29, 2017 |
| Results First Posted: | October 2, 2017 |
| Last Update Posted: | January 21, 2020 |