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)

• ClinicalTrials.gov Identifier: NCT01578239
• Recruitment Status: Completed
• First Posted: April 16, 2012
• Results First Posted: October 2, 2017
• Last Update Posted: March 24, 2021
• Sponsor: Advanced Accelerator Applications
• Information provided by (Responsible Party): Advanced Accelerator Applications

• 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 [1]	116	113
Safety Set (SAF) [2]	112	111
Completed	94	88
Not Completed	22	25
[1] All randomized patients at the efficacy cut-off date were included in Full Analysis dataset (FAS); [2] All patients who received/took trial medication who were randomized up to the safety cut-off date of 30 June 2016 were included in the Safety Set (SAF)

Baseline Characteristics

Arm/Group Title		177Lu-DOTA0-Tyr3-Octreotate	Octreotide LAR	Total
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
Baseline Analysis Population Description		All patients who were randomized in the study.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	116 participants	113 participants	229 participants
		63.3 (9.4)	64.1 (9.7)	63.7 (9.53)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	116 participants	113 participants	229 participants
	Female	53 45.7%	60 53.1%	113 49.3%
	Male	63 54.3%	53 46.9%	116 50.7%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants	Number Analyzed	116 participants	113 participants	229 participants
Belgium		4	2	6
France		12	9	21
Germany		10	7	17
Italy		5	9	14
Portugal		1	0	1
Spain		5	6	11
United Kingdom		13	11	24
United States		66	69	135

Outcome Measures

1. Primary Outcome

Title	Progression Free Survival (PFS)
Description	Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. CT/MRI tumour assessment in both arms are performed every 12±1 weeks from the first treatment date.
Time Frame	after 74 centrally confirmed cases disease progression or death

Outcome Measure Data

Analysis Population Description

Full analysis data set

Arm/Group Title	177Lu-DOTA0-Tyr3-Octreotate	Octreotide LAR
Arm/Group Description:	[Not Specified]	[Not Specified]
Overall Number of Participants Analyzed	116	113
Median (95% Confidence Interval); Unit of Measure: months
	NA [1]; (NA to NA)	8.5; (5.8 to 9.1)

[1]

Median progression free survival was not yet reached for 177Lu-DOTA0-Tyr3-Octreotate arm at the time the primary endpoint was evaluated (after 74 events of disease progression or death across study).

2. Secondary Outcome

Title	Objective Response Rate (ORR)
Description	Objective Response Rate (ORR) is calculated as the proportion of patients whose best overall response is either complete response (CR) or partial response (PR) according to RECIST 1.1.
Time Frame	From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to 5 years (estimated final analysis)

Outcome Measure Data Not Reported

3. Secondary Outcome

Title	Overall Survival (OS)
Description	Overall Survival (OS) is defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died by the date of analysis cut-off, OS was censored at the date of last known date patient alive.
Time Frame	From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to 5 years (estimated final analysis)

Outcome Measure Data Not Reported

4. Secondary Outcome

Title	Time to Tumour Progression (TTP)
Description	Time to Tumour Progression (TTP) is defined as the time from randomization to progression centrally assessed. It includes patients who dropped out due to toxicity, but omits patients who died without measured progression (censored to last follow-up date or death date).
Time Frame	From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to 5 years (estimated final analysis)vidence of tumor progression, assessed for approximately 5 years

Outcome Measure Data Not Reported

5. Secondary Outcome

Title	Duration of Response (DoR)
Description	The Duration of Response (DoR) is defined as the time from initially meeting the criteria for response (CR or PR) until the time of progression by RECIST.
Time Frame	From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to 5 years (estimated final analysis)

Outcome Measure Data Not Reported

6. Secondary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events
Description	The distribution of adverse events will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
Time Frame	From date of randomization until 30 day post-treatment safety follow-up, assessed up to 5 years (estimated final OS analysis)

Outcome Measure Data Not Reported

7. Secondary Outcome

Title	EORTC QLQ-C30 Questionnaire
Description	The Quality of Life Questionnaire C30 (QLQ-C30) was developed by the European Organization for Research and Treatment of Cancer (EORTC) to assess quality of life in cancer patients. It includes five function domains (physical, emotional, social, role, cognitive), eight symptoms (fatigue, pain, nausea/vomiting, constipation, diarrhea, insomnia, dyspnea, and appetite loss), as well as global health/quality-of-life and financial impact. Subjects respond on a four-point scale from "not at all" to "very much" for most items. Raw scores are linearly converted to a 0-100 scale with higher scores reflecting higher levels of function and higher levels of symptom burden.
Time Frame	From date of randomization until 30 day post-treatment safety follow-up, assessed up to 5 years (estimated final OS analysis)

Outcome Measure Data Not Reported

8. Secondary Outcome

Title	EORTC Quality of Life Questionnaire - Neuroendocrine Carcinoid Module (EORTC QLQ-GINET21)
Description	The Quality of Life GI Neuroendocrine Tumor survey (QLQ GINET21) contains a total of 21 items: four single-item assessments relating to muscle and/or bone pain (MBP), body image (BI), information (INF) and sexual functioning (SX), together with 17 items organized into five proposed scales: endocrine symptoms (ED; three items), GI symptoms (GI; five items), treatment-related symptoms (TR; three items), social functioning (SF) and disease-related worries (DRW; three items). The response format of the questionnaire is a four-point Likert scale. Responses are linearly transformed to a 0-100 scale using EORTC guidelines, with higher scores reflecting more severe symptoms.
Time Frame	From date of randomization until 30 day post-treatment safety follow-up, assessed up to 5 years (estimated final OS analysis)

Outcome Measure Data Not Reported

Adverse Events

Time Frame	Adverse event listing based on cutoff date of 30 June 2016, and includes data for 2 patients randomized after primary endpoint cutoff (74 events of PFS) was achieved.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	177Lu-DOTA0-Tyr3-Octreotate		Octreotide LAR
Arm/Group Description	[Not Specified]		[Not Specified]
All-Cause Mortality
	177Lu-DOTA0-Tyr3-Octreotate		Octreotide LAR
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	177Lu-DOTA0-Tyr3-Octreotate		Octreotide LAR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	35/112 (31.25%)		27/111 (24.32%)
Blood and lymphatic system disorders
Lymphopenia † 1	2/112 (1.79%)	2	0/111 (0.00%)	0
Anemia † 1	0/112 (0.00%)	0	1/111 (0.90%)	1
Neutropenia † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Refractory cytopenia with unilineage dysplasia † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Cardiac disorders
Acute myocardial infarction † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Angina pectoris † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Arteriospasm coronary † 1	0/112 (0.00%)	0	1/111 (0.90%)	1
Atrioventricular block second degree † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Cardiac arrest † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Cardiac failure congestive † 1	0/112 (0.00%)	0	1/111 (0.90%)	1
Silent myocardial infarction † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Gastrointestinal disorders
Nausea † 1	0/112 (0.00%)	0	1/111 (0.90%)	1
Abdominal Pain † 1	3/112 (2.68%)	3	1/111 (0.90%)	1
Diarrhea † 1	0/112 (0.00%)	0	1/111 (0.90%)	1
Vomiting † 1	2/112 (1.79%)	2	2/111 (1.80%)	2
Ascites † 1	1/112 (0.89%)	1	1/111 (0.90%)	1
Haemotochezia † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Small intestinal obstruction † 1	1/112 (0.89%)	1	2/111 (1.80%)	2
Abdominal pain lower † 1	0/112 (0.00%)	0	2/111 (1.80%)	2
Gastrointestinal obstruction † 1	0/112 (0.00%)	0	1/111 (0.90%)	1
Anal hemorrhage † 1	0/112 (0.00%)	0	1/111 (0.90%)	1
Duodenal obstruction † 1	0/112 (0.00%)	0	1/111 (0.90%)	1
Ileus † 1	0/112 (0.00%)	0	1/111 (0.90%)	1
Impaired gastric emptying † 1	0/112 (0.00%)	0	1/111 (0.90%)	1
Intestinal obstruction † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Gastritis † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Malignant bowel obstruction † 1	0/112 (0.00%)	0	1/111 (0.90%)	1
Oesophagitis † 1	0/112 (0.00%)	0	1/111 (0.90%)	1
General disorders
General physical health deterioration † 1	2/112 (1.79%)	2	1/111 (0.90%)	1
Complication of device insertion † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Device occlusion † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Generalized edema † 1	0/112 (0.00%)	0	1/111 (0.90%)	1
Injection site hypersensitivity † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Pyrexia † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Hepatobiliary disorders
Cholecystitis † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Cholecystitis acute † 1	0/112 (0.00%)	0	1/111 (0.90%)	1
Cholestasis † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Hepatic encephalopathy † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Hepatocellular injury † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Infections and infestations
Clostridium difficile infection † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Device related infection † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Diverticulitis † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Pneumocystis jirovecii pneumonia † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Respiratory tract infection † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Sepsis † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Injury, poisoning and procedural complications
Femur fracture † 1	2/112 (1.79%)	2	0/111 (0.00%)	0
Limb injury † 1	0/112 (0.00%)	0	1/111 (0.90%)	1
Limb traumatic amputation † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Procedural complication † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Metabolism and nutrition disorders
Dehydration † 1	1/112 (0.89%)	2	1/111 (0.90%)	1
Fluid retention † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Hyperuricaemia † 1	0/112 (0.00%)	0	1/111 (0.90%)	1
Hypokalaemia † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Musculoskeletal and connective tissue disorders
Muscular weakness † 1	0/112 (0.00%)	0	1/111 (0.90%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression † 1	2/112 (1.79%)	2	5/111 (4.50%)	6
Basal cell carcinoma † 1	0/112 (0.00%)	0	1/111 (0.90%)	1
Carcinoid crisis † 1	0/112 (0.00%)	0	1/111 (0.90%)	1
Diffuse large B-cell lymphoma † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Neoplasm progression † 1	0/112 (0.00%)	0	1/111 (0.90%)	1
Oesophageal adenocarcinoma † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Refractory cytopenia with multilineage dysplasia † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Tumor invasion † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Nervous system disorders
Hemorrhage intracranial † 1	0/112 (0.00%)	0	1/111 (0.90%)	1
Syncope † 1	0/112 (0.00%)	0	1/111 (0.90%)	1
Thrombotic cerebral infarction † 1	0/112 (0.00%)	0	1/111 (0.90%)	1
Transient global amnesia † 1	0/112 (0.00%)	0	1/111 (0.90%)	1
Psychiatric disorders
Anxiety † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Delirium † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Renal and urinary disorders
Acute kidney injury † 1	4/112 (3.57%)	4	1/111 (0.90%)	1
Acute prerenal failure † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Renal impairment † 1	0/112 (0.00%)	0	1/111 (0.90%)	1
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Cough † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Pleural effusion † 1	0/112 (0.00%)	0	1/111 (0.90%)	1
Surgical and medical procedures
Coronary artery bypass † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Vascular disorders
Inferior vena cava † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Pulmonary embolism † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Shock † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
Syncope † 1	1/112 (0.89%)	1	0/111 (0.00%)	0
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA Version 18.0
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	177Lu-DOTA0-Tyr3-Octreotate		Octreotide LAR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	110/112 (98.21%)		101/111 (90.99%)
Blood and lymphatic system disorders
Anemia † 1	18/112 (16.07%)	23	8/111 (7.21%)	10
Lymphopenia † 1	18/112 (16.07%)	24	0/111 (0.00%)	0
Thrombocytopenia † 1	16/112 (14.29%)	29	0/111 (0.00%)	0
Haematuria † 1	7/112 (6.25%)	9	2/111 (1.80%)	2
Gastrointestinal disorders
Nausea † 1	72/112 (64.29%)	161	13/111 (11.71%)	16
Vomiting † 1	58/112 (51.79%)	125	9/111 (8.11%)	12
Diarrhoea † 1	29/112 (25.89%)	41	19/111 (17.12%)	24
Abdominal pain † 1	27/112 (24.11%)	40	20/111 (18.02%)	22
Abdominal distension † 1	18/112 (16.07%)	22	14/111 (12.61%)	17
Constipation † 1	11/112 (9.82%)	12	6/111 (5.41%)	6
Dyspepsia † 1	7/112 (6.25%)	11	7/111 (6.31%)	13
Flatulence † 1	6/112 (5.36%)	6	6/111 (5.41%)	6
Abdominal pain upper † 1	6/112 (5.36%)	9	2/111 (1.80%)	4
General disorders
Fatigue † 1	42/112 (37.50%)	61	29/111 (26.13%)	31
Oedema peripheral † 1	18/112 (16.07%)	25	10/111 (9.01%)	10
Asthenia † 1	8/112 (7.14%)	11	8/111 (7.21%)	8
Pyrexia † 1	8/112 (7.14%)	10	3/111 (2.70%)	3
Influenza like illness † 1	6/112 (5.36%)	13	4/111 (3.60%)	5
Infections and infestations
Urinary tract infection † 1	7/112 (6.25%)	7	7/111 (6.31%)	8
Investigations
Weight decreased † 1	9/112 (8.04%)	11	8/111 (7.21%)	10
Gamma-glutamyltransferase increased † 1	7/112 (6.25%)	10	9/111 (8.11%)	10
Blood alkaline phosphatase increased † 1	7/112 (6.25%)	8	8/111 (7.21%)	10
Platelet count decreased † 1	13/112 (11.61%)	18	2/111 (1.80%)	2
Lymphocyte count decreased † 1	12/112 (10.71%)	24	2/111 (1.80%)	2
Blood creatinine increased † 1	7/112 (6.25%)	10	6/111 (5.41%)	6
Alanine aminotransferase increased † 1	5/112 (4.46%)	5	7/111 (6.31%)	10
Aspartate aminotransferase increased † 1	4/112 (3.57%)	5	8/111 (7.21%)	12
Blood bilirubin increased † 1	7/112 (6.25%)	9	2/111 (1.80%)	3
White blood cell count decreased † 1	7/112 (6.25%)	12	1/111 (0.90%)	2
Hyperglycaemia † 1	10/112 (8.93%)	16	10/111 (9.01%)	16
Hypokalaemia † 1	8/112 (7.14%)	9	9/111 (8.11%)	11
Hyponatraemia † 1	7/112 (6.25%)	8	4/111 (3.60%)	6
Metabolism and nutrition disorders
Decreased appetite † 1	23/112 (20.54%)	35	12/111 (10.81%)	12
Musculoskeletal and connective tissue disorders
Back pain † 1	14/112 (12.50%)	19	11/111 (9.91%)	12
Arthralgia † 1	12/112 (10.71%)	16	11/111 (9.91%)	16
Pain in extremity † 1	12/112 (10.71%)	15	6/111 (5.41%)	7
Musculoskeletal pain † 1	5/112 (4.46%)	5	6/111 (5.41%)	8
Muscle spasms † 1	7/112 (6.25%)	11	2/111 (1.80%)	3
Headache † 1	19/112 (16.96%)	23	6/111 (5.41%)	28
Dysgeusia † 1	9/112 (8.04%)	9	2/111 (1.80%)	3
Syncope † 1	6/112 (5.36%)	6	2/111 (1.80%)	2
Nervous system disorders
Dizziness † 1	19/112 (16.96%)	23	9/111 (8.11%)	12
Psychiatric disorders
Anxiety † 1	12/112 (10.71%)	13	6/111 (5.41%)	7
Insomnia † 1	3/112 (2.68%)	3	7/111 (6.31%)	12
Respiratory, thoracic and mediastinal disorders
Dyspnoea † 1	12/112 (10.71%)	15	9/111 (8.11%)	11
Cough † 1	11/112 (9.82%)	13	7/111 (6.31%)	7
Skin and subcutaneous tissue disorders
Alopecia † 1	13/112 (11.61%)	14	2/111 (1.80%)	2
Vascular disorders
Flushing † 1	16/112 (14.29%)	19	10/111 (9.01%)	12
Hypertension † 1	13/112 (11.61%)	20	8/111 (7.21%)	8
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA Version 18.0

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.

Results Point of Contact

• Name/Title: Study Director
• Organization: Novartis Pharmaceuticals
• Phone: 862-778-8300
• EMail: Novartis.email@novartis.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Strosberg J, Kunz PL, Hendifar A, Yao J, Bushnell D, Kulke MH, Baum RP, Caplin M, Ruszniewski P, Delpassand E, Hobday T, Verslype C, Benson A, Srirajaskanthan R, Pavel M, Mora J, Berlin J, Grande E, Reed N, Seregni E, Paganelli G, Severi S, Morse M, Metz DC, Ansquer C, Courbon F, Al-Nahhas A, Baudin E, Giammarile F, Taïeb D, Mittra E, Wolin E, O'Dorisio TM, Lebtahi R, Deroose CM, Grana CM, Bodei L, Öberg K, Polack BD, He B, Mariani MF, Gericke G, Santoro P, Erion JL, Ravasi L, Krenning E; NETTER-1 study group. Impact of liver tumour burden, alkaline phosphatase elevation, and target lesion size on treatment outcomes with (177)Lu-Dotatate: an analysis of the NETTER-1 study. Eur J Nucl Med Mol Imaging. 2020 Sep;47(10):2372-2382. doi: 10.1007/s00259-020-04709-x. Epub 2020 Mar 2.

Strosberg J, Wolin E, Chasen B, Kulke M, Bushnell D, Caplin M, Baum RP, Kunz P, Hobday T, Hendifar A, Oberg K, Sierra ML, Thevenet T, Margalet I, Ruszniewski P, Krenning E; NETTER-1 Study Group. Health-Related Quality of Life in Patients With Progressive Midgut Neuroendocrine Tumors Treated With (177)Lu-Dotatate in the Phase III NETTER-1 Trial. J Clin Oncol. 2018 Sep 1;36(25):2578-2584. doi: 10.1200/JCO.2018.78.5865. Epub 2018 Jun 7.

Strosberg J, El-Haddad G, Wolin E, Hendifar A, Yao J, Chasen B, Mittra E, Kunz PL, Kulke MH, Jacene H, Bushnell D, O'Dorisio TM, Baum RP, Kulkarni HR, Caplin M, Lebtahi R, Hobday T, Delpassand E, Van Cutsem E, Benson A, Srirajaskanthan R, Pavel M, Mora J, Berlin J, Grande E, Reed N, Seregni E, Öberg K, Lopera Sierra M, Santoro P, Thevenet T, Erion JL, Ruszniewski P, Kwekkeboom D, Krenning E; NETTER-1 Trial Investigators. Phase 3 Trial of (177)Lu-Dotatate for Midgut Neuroendocrine Tumors. N Engl J Med. 2017 Jan 12;376(2):125-135. doi: 10.1056/NEJMoa1607427.

• 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: March 24, 2021