Carcinoma, HepatocellularPhase 3NCT00386984
Hector-Study to Evaluate the Efficacy of Octreotide in Patients With Inoperable Hepatocellular Carcinoma
A Phase 3 study testing Somatostatin (octreotide) in people with Carcinoma, Hepatocellular, run by University Hospital Freiburg at 1 site in Germany.
Trial summary
A preliminary study has shown that the hormone-similar, growth-retarding drug octreotide can prolong survival time in patients with primary liver cancer. Due to methodological deficiencies of the preliminary study the results will be re-checked by the comparison of octreotide with an pseudo-drug (so-called placebo)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- Somatostatin (octreotide)
- How many people
- 108 participants
- Where
- 1 siteGermany
- Study dates
- Oct 1999to Feb 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inoperable patients
- histologically confirmed HCC or patients who refuse surgery and who otherwise (e.g. due to the advanced tumor stage) are not applicable for palliative local therapy (e.g. PEI, TACE, RFTA).
- Age: 18 years or older
Who cannot join
- General:
- Patient with symptomatic Cholecyst-/Choledocholithiasis
- Patient with severe psychiatric disease.
- Participation in another clinical trial within the last 4 weeks.
- Simultaneous participation in another clinical examination.
- Legally incapacitated patient, who is not able, to understand nature, meaning and consequence of the study.
Show all 20Show fewer
- Continuous drug or alcohol abuse.
- Patient with known HIV infection and antiretroviral therapy.
- Patient with not controllable infection disease.
- Pregnancy.
- Study- and indication-specific exclusion criteria:
- Secondary malignant tumor without complete remission.
- Secondary malignant tumor with complete remission but current adjuvant therapy.
- Preliminary or current therapy with tamoxifen
- Pretreatment of the HCC.
- First-time diagnosis > 6 months before inclusion into the study.
- Severe hepatic encephalopathy, refractory to any treatment.
- Patients with operable HCC.
- Contraindication to i.m. injections.
- Hypersensitivity to octreotide.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
About this study
Official title: Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III-Study to Evaluate the Efficacy of Octreotide in Patients With Inoperable Hepatocellular Carcinoma
A preliminary study has shown that the hormone-similar, growth-retarding drug octreotide can prolong survival time in patients with primary liver cancer. Due to methodological deficiencies of the preliminary study the results will be re-checked by the comparison of octreotide with an pseudo-drug (so-called placebo) primarily regarding to the survival time and secondarily concerning costs, side effects, patient cooperation and quality of life as well as specific conditions in the tumor tissue in both groups with 108 patients with primary liver cancer.
Read the detailed description
A pilot study showed that octreotide can prolong survival time of patients with HCC. Due to methodological deficiencies the results of this pilot study will be re-evaluated by comparison of octreotide versus placebo primarily regarding to the global survival time and secondarily concerning the costs, side effects, patient compliance and quality of life as well as the Somatostatin receptors in the tumor tissue and its prognostic relevance in both groups with 108 patients with hepatocellular carcinoma.
An interim analysis was done after occurrence of the half of the events (deaths). No significant effect could be shown.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- Somatostatin (octreotide)
- Keywords
- hepatocellular carcinoma; Sandostatin-LAR; RCT
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Somatostatin (octreotide)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival time
Secondary outcomes (6)
Costs of the treatment measured by days of in-patient treatment
Side effects
Patient compliance
Quality of life
Somatostatin receptors in the tumor tissue
Prognostic relevance of the Somatostatin receptors
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2006 (estimated)
- Study startOct 1999
- Study completionFeb 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 108 participants
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, Deutsche Krebshilfe e.V., Bonn (Germany), Novartis
- Investigators
- Hans-Peter Allgaier, PD, Principal investigator, Evangelischen Diakoniekrankenhaus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00386984
- Sponsor's protocol ID
- S 980916
- Status last verified
- Oct 2006
- First submitted
- 11 Oct 2006
- Last updated
- 12 Oct 2006
- Results posted
- No
Publications
Allgaier HP, Becker G, Blum HE. [A therapeutic study of hepatocellular carcinoma using octreotide (HECTOR). Hepatocellular Carcinoma: Treatment with Octreotide]. Dtsch Med Wochenschr. 2000 Mar 17;125(11):320. No abstract available. German.
PubMed 10761474
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III-Study to Evaluate the Efficacy of Octreotide in Patients With Inoperable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00386984
- Acronym / sponsor ID
- S 980916
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- hepatocellular carcinoma; Sandostatin-LAR; RCT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research, Deutsche Krebshilfe e.V., Bonn (Germany), Novartis
- Study start
- Oct 1999
- Study completion
- Feb 2003
- First posted
- 12 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A preliminary study has shown that the hormone-similar, growth-retarding drug octreotide can prolong survival time in patients with primary liver cancer. Due to methodological deficiencies of the preliminary study the results will be re-checked by the comparison of octreotide with an pseudo-drug (so-called placebo) primarily regarding to the survival time and secondarily concerning costs, side effects, patient cooperation and quality of life as well as specific conditions in the tumor tissue in both groups with 108 patients with primary liver cancer.
Detailed description
A pilot study showed that octreotide can prolong survival time of patients with HCC. Due to methodological deficiencies the results of this pilot study will be re-evaluated by comparison of octreotide versus placebo primarily regarding to the global survival time and secondarily concerning the costs, side effects, patient compliance and quality of life as well as the Somatostatin receptors in the tumor tissue and its prognostic relevance in both groups with 108 patients with hepatocellular carcinoma.
An interim analysis was done after occurrence of the half of the events (deaths). No significant effect could be shown.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Inoperable patients
- histologically confirmed HCC or patients who refuse surgery and who otherwise (e.g. due to the advanced tumor stage) are not applicable for palliative local therapy (e.g. PEI, TACE, RFTA).
- Age: 18 years or older
Key exclusion criteria (20 listed)
- Patient with symptomatic Cholecyst-/Choledocholithiasis
- Patient with severe psychiatric disease.
- Participation in another clinical trial within the last 4 weeks.
- Simultaneous participation in another clinical examination.
- Legally incapacitated patient, who is not able, to understand nature, meaning and consequence of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Somatostatin (octreotide) | Drug | – |
Primary outcome
Overall survival time
6 secondary outcomes
Costs of the treatment measured by days of in-patient treatment
Side effects
Patient compliance
Quality of life
Somatostatin receptors in the tumor tissue
Prognostic relevance of the Somatostatin receptors
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2006.
- Results publication: PubMed 10761474Allgaier HP, Becker G, Blum HE. [A therapeutic study of hepatocellular carcinoma using octreotide (HECTOR). Hepatocellular Carcinoma: Treatment with Octreotide]. Dtsch Med Wochenschr. 2000 Mar 17;125(11):320. No abstract available. German.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans-Peter Allgaier, PD principal investigator
Evangelischen Diakoniekrankenhaus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Somatostatin (octreotide) in people with Carcinoma, Hepatocellular, run by University Hospital Freiburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival time. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00386984, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2006.