- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00434668
Evaluation of Tolerability of Adjuvant Cisplatin/Docetaxel in Completely Resected Stage IB/II Non-Small Cell Lung Cancer (TOLEDO)
November 29, 2010 updated by: University Hospital, Antwerp
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
99
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Antwerp
-
Antwerpen, Antwerp, Belgium, 2020
- ZNA Middelheim
-
Edegem, Antwerp, Belgium, 2650
- University Hospital Antwerp
-
Wilrijk, Antwerp, Belgium, 2610
- St Augustinus ziekenhuis
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- completely resected pathological stage IB or II NSCLC
- adequate haematological, renal and liver function and condition
Exclusion Criteria:
- previous chemo or radiotherapy for NSCLC
- bronchoalveolar cell subtype
- second active primary malignancy or serious concomitant medical disease
- difficulties with adequate follow-up
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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 Outcome Measures
Outcome Measure |
---|
Overall toxicity
|
Progression free survival and overall survival
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Paul R. Germonpre, MD PhD, Universiteit Antwerpen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2005
Primary Completion (Actual)
September 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
February 12, 2007
First Submitted That Met QC Criteria
February 12, 2007
First Posted (Estimate)
February 13, 2007
Study Record Updates
Last Update Posted (Estimate)
November 30, 2010
Last Update Submitted That Met QC Criteria
November 29, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Docetaxel
- Cisplatin
- Vinorelbine
Other Study ID Numbers
- TOGA 0501
- Eudra CT 2005-004029-24
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non-small Cell Lung Cancer
-
WindMIL TherapeuticsBristol-Myers SquibbTerminatedNSCLC | Lung Cancer | Lung Cancer Metastatic | Lung Cancer, Non-small Cell | Non Small Cell Lung Cancer | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non Small Cell Lung Cancer MetastaticUnited States
-
University of California, San FranciscoAstraZenecaActive, not recruitingStage IIIA Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Cancer | Stage IB Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Cancer | Stage IIB Non-Small Cell Lung CancerUnited States
-
University of Wisconsin, MadisonNational Cancer Institute (NCI)CompletedStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Healthy, no Evidence of Disease | Limited Stage Small Cell Lung... and other conditionsUnited States
-
AIO-Studien-gGmbHBristol-Myers Squibb; Eli Lilly and Company; Merck Sharp & Dohme LLC; Pfizer; Gilead... and other collaboratorsRecruitingSmall-cell Lung Cancer | Non-small Cell Lung Cancer Metastatic | Non-small Cell Lung Cancer Stage I | Metastatic Non-small Cell Lung Cancer (NSCLC) | Non Small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer Stage IIGermany
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
-
Alexander ChiNot yet recruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Carcinoma | Non-small Cell Lung Cancer Stage IIChina
-
Karen KellyBristol-Myers Squibb; National Cancer Institute (NCI); TransgeneCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung CancerUnited States
-
National Cancer Institute (NCI)Not yet recruitingStage IIIA Non-small Cell Lung Cancer | Stage IA Non-small Cell Lung Cancer | Stage IB Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerCanada
-
Memorial Sloan Kettering Cancer CenterAstraZenecaRecruitingNSCLC | Lung Cancer | Non-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | PD-L1 Gene Mutation | Non-small Cell Lung Cancer Stage IIIA | Non-small Cell Lung Cancer Stage IIUnited States
-
Virginia Commonwealth UniversityNational Cancer Institute (NCI)WithdrawnStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States
Clinical Trials on cisplatin/docetaxel
-
SanofiCompletedLung NeoplasmsFrance, Netherlands, Spain, Turkey, Belgium, Finland, Italy, United Kingdom
-
Optimal Health ResearchCompletedBreast Cancer | Lung Cancer | Prostate CancerUnited States
-
Air Force Military Medical University, ChinaUnknown
-
National Cancer Center, KoreaSeoul National University Bundang Hospital; Gachon University Gil Medical Center and other collaboratorsUnknownGastric CancerKorea, Republic of
-
University of ChicagoTerminatedNon-small Cell Lung CancerUnited States
-
Spanish Lung Cancer GroupTerminatedNon Small Cell Lung Cancer | BRCA1 MutationSpain
-
Sun Yat-sen UniversityRecruitingNasopharyngeal CarcinomaChina
-
Asan Medical CenterCompletedResected Advanced Gastric CancerKorea, Republic of
-
Hospital of Stomatology, Wuhan UniversityJiangsu HengRui Medicine Co., Ltd.RecruitingOral Squamous Cell CarcinomaChina
-
Gyeongsang National University HospitalCompletedNon-small Cell Lung CancerKorea, Republic of