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Radiopharmaceutical

177Lu-DOTATOC for Neuroendocrine Tumors

Phase 2

Waitlist Available

Led By Francois Benard, MD

Research Sponsored by British Columbia Cancer Agency

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial is to compare the effectiveness of two types of PRRT, personalized and standard, in treating neuroendocrine tumors.

Eligible Conditions

Neuroendocrine Tumors
Gastrinoma
Insulinoma
Carcinoid Tumor
Pulmonary Carcinoid Tumor
VIPoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Compare the 12-month progression-free survival (PFS) of subjects receiving personalized or standard injected activity PRRT with Choi criteria.

Compare the 12-month progression-free survival (PFS) of subjects receiving personalized or standard injected activity PRRT with ITMO criteria.

Compare the 12-month progression-free survival (PFS) of subjects receiving personalized or standard injected activity PRRT with RECIST criteria.

+1 more

Secondary outcome measures

Correlation of QoL scores (EORTC GINET21) to ctDNA

Correlation of QoL scores (EORTC QLQ30) to ctDNA

Correlation of QoL scores (EQ-5D) to ctDNA

+6 more

Other outcome measures

PFS and QoL scores to ctDNA levels

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Personalized PRRTExperimental Treatment1 Intervention

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.

Group II: Standard PRRTActive Control1 Intervention

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.

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Who is running the clinical trial?

British Columbia Cancer AgencyLead Sponsor

171 Previous Clinical Trials

90,511 Total Patients Enrolled

4 Trials studying Neuroendocrine Tumors

870 Patients Enrolled for Neuroendocrine Tumors

Francois Benard, MDPrincipal InvestigatorBC Cancer

9 Previous Clinical Trials

5,054 Total Patients Enrolled

2 Trials studying Neuroendocrine Tumors

860 Patients Enrolled for Neuroendocrine Tumors

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What safeguards exist to ensure that 177Lu-DOTATOC is harmless to those who receive it?

"Our team at Power gave 177Lu-DOTATOC a safety rating of 2, meaning there is evidence to suggest the drug's relative safety but no data on its efficacy."

Answered by AI

What is the projected participant count for this clinical trial?

"This clinical trial is no longer taking new participants. It was first posted on January 15th 2022 and the last update occured on November 2nd 2023. If you are searching for other studies, 177 trials involving vipoma-afflicted patients and 30 trials dealing with 177Lu-DOTATOC therapy currently have active recruitment campaigns."

Answered by AI

What further investigations have been conducted on the efficacy of 177Lu-DOTATOC?

"Currently, 30 clinical trials involving 177Lu-DOTATOC are active with 3 in Phase 3. Newcastle and Gateshead have the highest concentration of these studies; however, there are 238 locations worldwide running related research."

Answered by AI

Is recruitment for this research still underway?

"This trial is not recruiting new patients at this time. Last updated on November 2, 2022 and initially posted on January 15th 2023, it does not presently have any openings for participants. Those searching for other clinical trials may find 177 vipoma studies or 30 177Lu-DOTATOC studies actively seeking volunteers."

Answered by AI

What is the purpose of this trial's implementation?

"This 12-month trial aims to compare the progression-free survival of those undergoing personalized versus standard PRRT with Choi criteria. Additionally, the correlation between QoL scores and ctDNA will be investigated as well as quality of life questionnaire results (EORTC GINET21 & EQ-5D) before, during, and after treatment in both arms."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "177Lu-DOTATOC for the Treatment of Patients With Somatostatin Receptor Positive NETs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04915144.