NCT01915485

Brief Summary

Medullary thyroid cancer is a neuroendocrine tumour. As so, it has somatostatin receptors in its membrane. Furthermore, very little is available to treat patients who have disease progression. The investigators hypothesized that those tumors may respond to 177-Lu-DOTA Tyr3-octreotate which is a ligand to somatostatin receptors.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 1, 2013

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

September 7, 2016

Status Verified

September 1, 2016

Enrollment Period

3.3 years

First QC Date

August 1, 2013

Last Update Submit

September 2, 2016

Conditions

Medullary Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

  • Tumour Shrinkage

    RECIST 1.1 criteria

    6-8 months

Secondary Outcomes (1)

  • Quality of life improvement

    6-8 months

Study Arms (1)

Lu 177

EXPERIMENTAL

progressive metastatic medullary thyroid cancer

Radiation: Lu 177

Interventions

Lu 177RADIATION

Patients will be submitted to 4 cycles of 177-Lu with 200mCi each

Lu 177

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medullary Thyroid Cancer
  • Doubling time calcitonin and CEA less than 6 months
  • Measurable disease by cross- sectional imaging
  • Irresectable tumors masses
  • \> 18 years of age

You may not qualify if:

  • \< 18 years of age
  • Disease that can be treated with new surgical procedure
  • Stable disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional do Cancer do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, Brazil

RECRUITING

Related Publications (1)

  • Iten F, Muller B, Schindler C, Rochlitz C, Oertli D, Macke HR, Muller-Brand J, Walter MA. Response to [90Yttrium-DOTA]-TOC treatment is associated with long-term survival benefit in metastasized medullary thyroid cancer: a phase II clinical trial. Clin Cancer Res. 2007 Nov 15;13(22 Pt 1):6696-702. doi: 10.1158/1078-0432.CCR-07-0935.

    PMID: 18006770BACKGROUND

MeSH Terms

Conditions

Carcinoma, Medullary

Interventions

Lutetium-177

Condition Hierarchy (Ancestors)

Carcinoma, NeuroendocrineNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms, Ductal, Lobular, and MedullaryNeoplasms, Nerve Tissue

Study Officials

  • Fernanda Vaisman, MD, PhD

    National Cancer Institute, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernanda Vaisman, MD, PhD

CONTACT

(5521) 32071387fevaisman@globo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2013

First Posted

August 5, 2013

Study Start

August 1, 2013

Primary Completion

November 1, 2016

Study Completion

February 1, 2017

Last Updated

September 7, 2016

Record last verified: 2016-09

Locations

BR(1)