A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours

PHASE3CompletedINTERVENTIONAL
Enrollment

231

Participants

Timeline

Start Date

September 6, 2012

Primary Completion Date

July 31, 2015

Study Completion Date

January 18, 2021

Conditions
Carcinoid Tumor of the Small BowelNeuroendocrine Tumour
Interventions
DRUG

Octreotide LAR

"In the experimental arm, 30 mg Octreotide LAR treatment was given to the participants until the end of study for symptom control purpose, unless the participant progressed or died.~In the active comparator arm, 60 mg Octreotide LAR treatment was given to the participants every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died."

DRUG

177Lu-DOTA0-Tyr3-Octreotate

Four administrations of 7.4 GBq (200 mCi) 177Lu-DOTA0-Tyr3-Octreotate administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity.

Trial Locations (39)

3000

Digestive Oncology, Leuven Cancer Institute, Leuven

13353

Charité, Virchow-Klinikum, Gastroentrology, Hepatology & Endocrinology, Berlin

13385

Hôpital la Timone /CHU Marseille, Marseille

19104

Perelman Center for Advanced Medicine, Philadelphia

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

20141

IEO Istituto Europeo di Oncologia, Milan

27710

Duke University Medical Center, Durham

28034

Ramon y Cajal University Hospital, Madrid

31100

Institut Claudius Regaud, Toulouse

33612

Moffitt Cancer Center, Tampa

37232

Henry-Joyce Cancer Clinic, Nashville

44093

Hotel Dieu/CHU Nantes, Nantes

45429

Kettering Medical Center, Kettering

47014

Istituto Oncologico Romagnolo per lo Studio dei Tumori, Meldola

52242

University of Iowa Hospitals and Clinics, Iowa City

55131

Universitätsmedizin Mainz, Medizinische Klinik I Schwerpunkt Endokrinologie, Mainz

55905

Mayo Clinic, Rochester

56126

Azienda Ospedaliero - Universitaria Pisana (Presidio Ospedaliero S. Chiara), Pisa

62100

Presidio Osp. Di Macerata, Macerata

69002

Centre Hospitalier Lyon-Sud, Lyon

77030

University of Texas MD Anderson Cancer Center, Houston

77042

Excel Diagnostics and Nuclear Oncology Center, Houston

81675

Klinikum Rechts Isar, Nuclear Medicine, Munich

90048

Cedars-Sinai Medical Center Samuel Oschin Cancer Center, Los Angeles

92118

Hôpital Beaujon AP-HP, Clichy

94304

Stanford Cancer Center, Palo Alto

94805

Institut Gustave Roussy, Villejuif

99437

Zentralklinik Bad Berka, Bad Berka

60611-3015

Northwestern Medical Faculty Foundation, Chicago

02215

Dana Farber Cancer Institute, Boston

00189

"Università Sapienza di Roma, Facoltà di Medicina e Psicologia, Ospedale S. Andrea-Roma", Roma

3000-075

Centro Hospitalar e Universitario de Coimbra, Coimbra

4200-072

Instituto Português de Oncologia, Porto

08907

University Hospital of Bellvitge, Hospitalet de Llobregat (Barcelona)

OX3 7LE

University of Oxford, Oxford

G12 0YN

Beatson Oncology Centre, Glasgow

NW3 2QG

Royal Free Hospital, London

W12 0HS

Imperial College Healthcare Trust, Hammersmith Hospital, London

M20 4BX

The Christie NHS foundation Trust, Manchester

All Listed Sponsors
lead

Advanced Accelerator Applications

INDUSTRY