Esophageal CancerPhase 2CONKO-101NCT00759226
Chemotherapeutic Trial With Gemcitabine, Cisplatin, 5-FU and Folinic Acid in Esophageal Cancer
A Phase 2 study testing Gemcitabine, Cisplatin and 5-FU in people with Esophageal Cancer, run by CONKO-Studiengruppe at 1 site in Germany.
Trial summary
This multicenter open labeled phase 2 trial examines the efficacy of a combination of Gemcitabine 1000 mg/m2 (30 min), Cisplatin 30 mg/m2 (90 min), Folinic Acid 200 mg/m2 (30 min) and 5-FU 750 mg/m2 (24h CI) all given day 1,8 q D22 in patients with inoperable esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Gemcitabine, Cisplatin and 5-FU
- How many people
- 92 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2002to Aug 2007
- Phase
- Phase 2
- 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
- Age>=18
- Histologically proven inoperable esophageal cancer
- Karnofsky Performance status >=60%
- Estimated life expectancy of > 12 weeks
- Measurable disease
- No other oncologic therapy
Show all 11Show fewer
- Measurable disease
- Adequate bone marrow function
- Geographic proximity and compliance
- Informed consent
- Negative pregnancy test and adequate contraception
Who cannot join
- Insufficient hepatic or renal function
- Elevated serum calcium
- Pregnancy/breast feeding
- Active infection
- Other malignancies
- Systemic tumour complications requiring emergency interventions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Labeled Phase 2 Study of Gemcitabine in Combination With Cisplatin, 5-FU (24h CI) and Folinic Acid in Patients With Inoperable Esophageal Cancer
This multicenter open labeled phase 2 trial examines the efficacy of a combination of Gemcitabine 1000 mg/m2 (30 min), Cisplatin 30 mg/m2 (90 min), Folinic Acid 200 mg/m2 (30 min) and 5-FU 750 mg/m2 (24h CI) all given day 1,8 q D22 in patients with inoperable esophageal cancer. The combination was considered to be suitable for further evaluation with a freedom of progression rate (PR+CR+SD) of more than 60% and not be be of further interest with a rate of less than 40%. Given an alpha error of 5% and an beta error of 10% at least 66 evaluable patients were needed based on a 2-Stage Simon design with a first evaluation after 25 evaluable patients.
- Conditions
- Esophageal Cancer
- Being tested
- Gemcitabine, Cisplatin, 5-FU, Folinic Acid
- Keywords
- esophageal cancer, Gemcitabine, Cisplatin, 5-FU, Folinic Acid, inoperable esophageal cancer
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar
Gemcitabine 1000 mg/m2 (30 min)
CisplatinDrug
Also called Cisplatin medac
Cisplatin 30 mg/m2 (90 min)
5-FUDrug
Also called 5-FU medac
5-FU 750 mg/m2 (24h CI)
Folinic AcidDrug
Also called Rescuvolin
Folinic Acid 200 mg/m2 (30 min)
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint rate of freedom of progression (PR+CR+SD).
Measured: Max. 8 cycles of therapy
Secondary outcomes (1)
Secondary endpoint median survival, progression free survival and toxicity.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startJul 2002
- Primary completionJul 2005
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- CONKO-Studiengruppe
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, medac GmbH
- Investigators
- Hanno Riess, MD, PhD, Principal investigator, Charite Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00759226
- Sponsor's protocol ID
- CONKO-101
- Acronym
- CONKO-101
- Status last verified
- Sep 2008
- First submitted
- 24 Sep 2008
- Last updated
- 26 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Labeled Phase 2 Study of Gemcitabine in Combination With Cisplatin, 5-FU (24h CI) and Folinic Acid in Patients With Inoperable Esophageal Cancer
- ClinicalTrials.gov ID
- NCT00759226
- Acronym / sponsor ID
- CONKO-101 / CONKO-101
- Conditions
- Esophageal Cancer
- Keywords
- esophageal cancer, Gemcitabine, Cisplatin, 5-FU, Folinic Acid, inoperable esophageal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- CONKO-StudiengruppeUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, medac GmbH
- Study start
- Jul 2002
- Primary completion
- Jul 2005 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 25 Sep 2008 (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.
This multicenter open labeled phase 2 trial examines the efficacy of a combination of Gemcitabine 1000 mg/m2 (30 min), Cisplatin 30 mg/m2 (90 min), Folinic Acid 200 mg/m2 (30 min) and 5-FU 750 mg/m2 (24h CI) all given day 1,8 q D22 in patients with inoperable esophageal cancer. The combination was considered to be suitable for further evaluation with a freedom of progression rate (PR+CR+SD) of more than 60% and not be be of further interest with a rate of less than 40%. Given an alpha error of 5% and an beta error of 10% at least 66 evaluable patients were needed based on a 2-Stage Simon design with a first evaluation after 25 evaluable patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age>=18
- Histologically proven inoperable esophageal cancer
- Karnofsky Performance status >=60%
- Estimated life expectancy of > 12 weeks
- Measurable disease
Key exclusion criteria (6 listed)
- Insufficient hepatic or renal function
- Elevated serum calcium
- Pregnancy/breast feeding
- Active infection
- Other malignancies
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 |
|---|---|---|
| GemcitabineAlso: GemzarGemcitabine 1000 mg/m2 (30 min) | Drug | – |
| CisplatinAlso: Cisplatin medacCisplatin 30 mg/m2 (90 min) | Drug | – |
| 5-FUAlso: 5-FU medac5-FU 750 mg/m2 (24h CI) | Drug | – |
| Folinic AcidAlso: RescuvolinFolinic Acid 200 mg/m2 (30 min) | Drug | – |
Primary outcome
Primary endpoint rate of freedom of progression (PR+CR+SD).
Time frame: Max. 8 cycles of therapy
1 secondary outcome
Secondary endpoint median survival, progression free survival and toxicity.
Time frame: 3 years
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 26 Sep 2008.
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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.
Hanno Riess, MD, PhD principal investigator
Charite Universitätsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine, Cisplatin and 5-FU in people with Esophageal Cancer, run by CONKO-Studiengruppe 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 11 inclusion and 6 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 26 Sep 2008. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Primary endpoint rate of freedom of progression (PR+CR+SD). (time frame: Max. 8 cycles of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2008.