Non-small Cell Lung CancerPhase 2TOLEDONCT00434668
Evaluation of Tolerability of Adjuvant Cisplatin/Docetaxel in Completely Resected Stage IB/II Non-Small Cell Lung Cancer
A Phase 2 study testing cisplatin/docetaxel and cisplatin/vinorelbine in people with Non-small Cell Lung Cancer, run by University Hospital, Antwerp at 3 sites in Belgium.
Trial summary
The aim of this study is to evaluate the tolerability (in terms of drug delivery and toxicity) of four cycles of adjuvant docetaxel plus cisplatin in patients with completely resected stage IB-II Non-Small Cell Lung Cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- cisplatin/docetaxel and cisplatin/vinorelbine
- How many people
- 99 participants
- Where
- 3 sitesBelgium
- Study dates
- Dec 2005to Nov 2010
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- completely resected pathological stage IB or II NSCLC
- adequate haematological, renal and liver function and condition
Who cannot join
- previous chemo or radiotherapy for NSCLC
- bronchoalveolar cell subtype
- second active primary malignancy or serious concomitant medical disease
- difficulties with adequate follow-up
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
ZNA Middelheim
Antwerp, Antwerp, 2020
University Hospital Antwerp
Edegem, Antwerp, 2650
St Augustinus ziekenhuis
Wilrijk, Antwerp, 2610
About this study
Official title: Randomized Phase II Study Evaluating The Tolerability Of Adjuvant Docetaxel-based Chemotherapy For Completely Resected Stage IB-II Non-Small Cell Lung Cancer (NSCLC): Toledo Trial
The aim of this study is to evaluate the tolerability (in terms of drug delivery and toxicity) of four cycles of adjuvant docetaxel plus cisplatin in patients with completely resected stage IB-II Non-Small Cell Lung Cancer. To avoid a selection bias, eligible patients will be randomised to receive cisplatin/docetaxel or cisplatin/vinorelbine.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- cisplatin/docetaxel, cisplatin/vinorelbine
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, Adjuvant chemotherapy for completely resected NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cisplatin/docetaxelDrug
cisplatin/vinorelbineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of delivery treatment; data collected during chemotherapy treatment
Toxicity (occurrence of any grade 4 toxicity); data collected at the end of each cycle
Secondary outcomes (2)
Overall toxicity
Progression free survival and overall survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2007 (estimated)
- Study startDec 2005
- Primary completionSep 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen, Sanofi
- Investigators
- Paul R. Germonpre, MD PhD, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00434668
- Sponsor's protocol ID
- TOGA 0501
- Other IDs
- Eudra CT 2005-004029-24
- Acronym
- TOLEDO
- Status last verified
- Nov 2010
- First submitted
- 12 Feb 2007
- Last updated
- 30 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study Evaluating The Tolerability Of Adjuvant Docetaxel-based Chemotherapy For Completely Resected Stage IB-II Non-Small Cell Lung Cancer (NSCLC): Toledo Trial
- ClinicalTrials.gov ID
- NCT00434668
- Acronym / sponsor ID
- TOLEDO / TOGA 0501
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Non-Small Cell Lung Cancer, NSCLC, Adjuvant chemotherapy for completely resected NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen, Sanofi
- Study start
- Dec 2005
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 13 Feb 2007 (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.
The aim of this study is to evaluate the tolerability (in terms of drug delivery and toxicity) of four cycles of adjuvant docetaxel plus cisplatin in patients with completely resected stage IB-II Non-Small Cell Lung Cancer. To avoid a selection bias, eligible patients will be randomised to receive cisplatin/docetaxel or cisplatin/vinorelbine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- completely resected pathological stage IB or II NSCLC
- adequate haematological, renal and liver function and condition
Key exclusion criteria (4 listed)
- previous chemo or radiotherapy for NSCLC
- bronchoalveolar cell subtype
- second active primary malignancy or serious concomitant medical disease
- difficulties with adequate follow-up
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 |
|---|---|---|
| cisplatin/docetaxel | Drug | – |
| cisplatin/vinorelbine | Drug | – |
Primary outcome
Success of delivery treatment; data collected during chemotherapy treatment
Toxicity (occurrence of any grade 4 toxicity); data collected at the end of each cycle
2 secondary outcomes
Overall toxicity
Progression free survival and overall survival
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 30 Nov 2010.
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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.
Paul R. Germonpre, MD PhD principal investigator
Universiteit Antwerpen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cisplatin/docetaxel and cisplatin/vinorelbine in people with Non-small Cell Lung Cancer, run by University Hospital, Antwerp at 3 sites in Belgium.
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 2 inclusion and 4 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 30 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. 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?
Success of delivery treatment; data collected during chemotherapy treatment. The study lists 2 primary outcomes in all. 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 30 Nov 2010.