NCT00978211

Brief Summary

The investigators aim to explore the efficacy of \[90Y-DOTA\]-TOC and \[177LuDOTA\]-TOC therapy in advanced neuroendocrine cancer. Therefore, the investigators assess response, survival and long-term safety profile of systemic \[90Y-DOTA\]-TOC and \[177LuDOTA\]-TOC treatment in metastasized neuroendocrine cancer patients. Adverse events are assessed according to the criteria of the National Cancer Institute. Survival analyses are performed using multiple regression models.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,499

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 1997

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 1997

Completed
12 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 7, 2015

Status Verified

August 1, 2015

Enrollment Period

16 years

First QC Date

September 15, 2009

Last Update Submit

August 5, 2015

Conditions

Neuroendocrine Tumors

Keywords

DOTATOCsomatostatinradiopeptideYttriumLutetiumneuroendocrinecancer

Outcome Measures

Primary Outcomes (1)

  • Response

    3 months

Secondary Outcomes (2)

  • Toxicity

    3 months

  • Survival

    life-long

Study Arms (1)

DOTA-TOC

EXPERIMENTAL

Treatment arm

Drug: DOTA-TOC Treatment

Interventions

DOTA-TOC TreatmentDRUG

Intravenous injections of DOTA-TOC. Repeated treatment cycles for responders, except in case of * renal toxicity * loss of patient transferability or * denial of further treatment.

Also known as: tetraazacyclododecanetetraacetic acid (DOTA) modified, somatostatin analog Tyr3-octreotide (TOC)
DOTA-TOC

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • histologically confirmed neuroendocrine cancer
  • stage IVc disease by definition of the American Joint Committee on Cancer, i.e. occurrence of distant metastases
  • visible tumor uptake in the pretherapeutic somatostatin receptor subtype 2 scintigraphy (111In-Octreoscan)

You may not qualify if:

  • concurrent anti-tumor treatment
  • secondary malignancies
  • pregnancy
  • breast-feeding
  • incontinence
  • severe concomitant illness including severe psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (4)

  • Otte A, Mueller-Brand J, Dellas S, Nitzsche EU, Herrmann R, Maecke HR. Yttrium-90-labelled somatostatin-analogue for cancer treatment. Lancet. 1998 Feb 7;351(9100):417-8. doi: 10.1016/s0140-6736(05)78355-0. No abstract available.

    PMID: 9482300BACKGROUND

  • 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

  • Iten F, Muller B, Schindler C, Rasch H, Rochlitz C, Oertli D, Maecke HR, Muller-Brand J, Walter MA. [(90)Yttrium-DOTA]-TOC response is associated with survival benefit in iodine-refractory thyroid cancer: long-term results of a phase 2 clinical trial. Cancer. 2009 May 15;115(10):2052-62. doi: 10.1002/cncr.24272.

    PMID: 19280592BACKGROUND

  • Marincek N, Jorg AC, Brunner P, Schindler C, Koller MT, Rochlitz C, Muller-Brand J, Maecke HR, Briel M, Walter MA. Somatostatin-based radiotherapy with [90Y-DOTA]-TOC in neuroendocrine tumors: long-term outcome of a phase I dose escalation study. J Transl Med. 2013 Jan 15;11:17. doi: 10.1186/1479-5876-11-17.

    PMID: 23320604DERIVED

MeSH Terms

Conditions

Neuroendocrine TumorsNeoplasms

Interventions

1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve Tissue

Study Officials

  • Martin A Walter, MD, Dr.

    Institute of Nuclear Medicine; Inselspital Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2009

First Posted

September 16, 2009

Study Start

September 1, 1997

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

August 7, 2015

Record last verified: 2015-08

Locations

CH(1)