Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Neuroendocrine Tumors

Carcinoid Tumor

Insulinoma

Gastrinoma

Vipoma

Zollinger-Ellison Syndrome

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Adenoma

Adenoma, Islet Cell

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Carcinoma, Islet Cell

Neuroendocrine Tumor

Gastro-enteropancreatic Neuroendocrine Tumor

VIPoma

Neuroepithelioma

Pancreatic Cancer

All Drugs and Chemicals

Somatostatin

Edotreotide

Edotreotide lutetium LU-177

Radiopharmaceuticals

For standard PRRT 177Lu-DOTATOC therapy, the administered activity will be 7.4 GBq ± 10% as an intravenous infusion over a time of 10 to 30 minutes.

For 177Lu-DOTATOC therapy, for the first cycle the administered activity will be 7.4 GBq ± 10% as an intravenous infusion over a time of 10 to 30 minutes.Subsequent cycles will be adjusted based on dosimetry calculations.

Subjects will receive 177Lu-DOTATOC PRRT treatment over 4 cycles, each cycle occurs every 8 weeks.

177Lu-DOTATOC

Francois Benard, MD

This study is to assess if personalized peptide receptor radionuclide therapy (PRRT) with 177Lu-DOTATOC results in fewer adverse events than standard PRRT. Subjects will be randomized to either receive personalized or standard PRRT. Personalized PRRT will be determined based on dosimetry calculations after the first cycle. In addition comparisons, will be made with progression-free survival, serial CT imaging, ctDNA, and quality of life questionnaires. Subjects will be followed for 5 years or until they have progression and are switched to another systemic treatment (not including treatment with somatostatin analogues).

Overall, 200 subjects will be randomized (1:1 randomization ratio) to receive standard injected activities of 177Lu-DOTATOC PRRT or personalized injection of 177Lu-DOTATOC PRRT. Randomization will be stratified for grade and primary location.

Screening Phase: Subjects will be screened against the inclusion and exclusion criteria. Screening by SSR imaging will be completed to determine expression of SSR and feasibility of treatment by PRRT. Once eligibility has been confirmed they will be randomized. Subjects will undergo a physical exam, complete a medical history questionnaire, quality of life questionnaires, blood work, and a diagnostic CT.

Treatment Phase: During the treatment phase, subjects will undergo 4 cycles of treatment. Each treatment cycle will be followed by 2 dosimetry SPECT/CT scans on day 1 (18 - 32 hours after treatment administration) and day 2 (64 - 80h after treatment administration) After cycle 3 quality of life questionnaires will be completed again.

Follow up Phase: At the end of treatment or after discontinuation of any cause, subjects will be followed for 5 years to continue data collection for the other objectives. Objective tumour response will be assessed every 6 months by diagnostic CT according to the RECIST 1.1 criteria.

This is a prospective randomized phase II study two-arm study of efficacy and safety of 177Lu-DOTATOC for treatment of patients with NETs who are referred to BC Cancer - Vancouver for treatment of progressive tumours.

177Lu-DOTATOC for the Treatment of Patients With Somatostatin Receptor Positive NETs

A Prospective Randomized Study of the Efficacy and Safety of 177Lu-DOTATOC With Either Standard or Personalized Dosing for the Treatment of Patients With Somatostatin Receptor Positive NETs

To assess correlation of PFS and QoL scores (EORTC QLQ30) to ctDNA levels (ctDNA allele frequency change from pre-treatment to on-treatment), the following tests will be used, Spearman correlation for quality of life and Kaplan- Meier curves stratified at a median for PFS.

Frequency of AEs, will be compared between the two treatment arms.

PFS will be determined by RECIST1.1 criteria on serial CT, and analysed independently. The 12-month PFS will be evaluated by univariate analysis but different criteria for determination of PFS will be compared.

PFS will be determined by biochemical criteria (ITMO) on serial CT, and analysed independently. The 12-month PFS will be evaluated by univariate analysis but different criteria for determination of PFS will be compared.

PFS will be determined by Choi criteria on serial CT, and analysed independently. The 12-month PFS will be evaluated by univariate analysis but different criteria for determination of PFS will be compared.

Response rate as determined by structural criteria RECIST1.1

Response rate as determined by structural criteria Choi.

Response rate as determined by structural criteria biochemical markers (ITMO criteria) (chromogranin A, 24h urinary HIAA).

For QoL questionnaire scores (EORTC QLQ30) before, during, and after treatment

For QoL questionnaire scores (EORTC GINET21) before, during, and after treatment

For QoL questionnaire scores (EQ-5D) before, during, and after treatment

To assess correlation of QoL scores (EORTC QLQ30) to ctDNA allele frequency change from pre-treatment to on-treatment, using spearman correlation

To assess correlation of QoL scores (EORTC GINET21) to ctDNA allele frequency change from pre-treatment to on-treatment, using spearman correlation

To assess correlation of QoL scores (EQ-5D) to ctDNA allele frequency change from pre-treatment to on-treatment, using spearman correlation

British Columbia Cancer Agency

Antineoplastic Agents

Epothilones

Epothilone B

Tubulin Modulators

Antimitotic Agents

EPO906 epothilone B

Novartis Pharmaceuticals

This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause metastatic carcinoid and other neuroendocrine tumors.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
177Lu-DOTATOC for the Treatment of Patients With Somatostatin Receptor Positive NETs	NCT04915144	Neuroendocrine ... Carcinoid Tumor Pulmonary Carci... Gastroenteropan... Vipoma Insulinoma Gastrinoma	177Lu-DOTATOC	19 Years -	British Columbia Cancer Agency
EPO906 in Carcinoid and Other Neuroendocrine Tumors	NCT00050349	Carcinoid Neuroendocrine ...	EPO906 epothilo...	18 Years -	Novartis
EPO906 in Carcinoid and Other Neuroendocrine Tumors	NCT00050349	Carcinoid Neuroendocrine ...	EPO906 epothilo...	18 Years -	Novartis
177Lu-DOTATOC for the Treatment of Patients With Somatostatin Receptor Positive NETs	NCT04915144	Neuroendocrine ... Carcinoid Tumor Pulmonary Carci... Gastroenteropan... Vipoma Insulinoma Gastrinoma	177Lu-DOTATOC	19 Years -	British Columbia Cancer Agency

Spots Global Cancer Trial Database for vipoma

Every month we try and update this database with for vipoma cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for vipoma

Every month we try and update this database with for vipoma cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for vipoma cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.