MedDataX Logo

Safety Study of Adjuvant Docetaxel-Carboplatin Treatment for Resected Lung Cancer

NCT ID: NCT00883675

Last Updated: 2013-12-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine whether it is safe to treat lung cancer patients who have undergone an attempt at curative resection with the combination of docetaxel and carboplatin.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients with stage Ib - IIIa NSCLC participated in an open-label, single arm study to assess the safety and tolerability of docetaxel (75 mg/kg) and carboplatin (AUC 5.5) administered for 3 cycles after resection for curative intent. The primary endpoint of the study was safety, as reflected by a febrile neutropenia rate of \<10%. Other endpoints assessed protocol compliance and the impact of minimally invasive surgical technique.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-small Cell Lung Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Lung cancer Adjuvant therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment

Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses

Group Type EXPERIMENTAL

Docetaxel-Carboplatin

Intervention Type DRUG

Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin AUC 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Docetaxel-Carboplatin

Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin AUC 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Taxotere, Paraplatin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Non-small cell lung cancer stage IB - IIIA, complete resection with mediastinal lymph node dissection
* ECOG status 0-1
* \>14 and \<56 days since resection

Exclusion Criteria

* Prior chemotherapy and/or radiation therapy for lung cancer
* Peripheral neuropathy \> grade 1
* Concurrent other malignancies, other than basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
* Medical condition that will not permit treatment or follow up according to the protocol
* Prior treatment with docetaxel or carboplatin
* Hypersensitivity to polysorbate 80, platinum-containing compounds or mannitol
* Treatment with other investigational anti-cancer drugs within 30 days of registration
* Pregnant or nursing women
* HIV-positive patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sanofi

INDUSTRY

Sponsor Role collaborator

Michael Mann

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michael Mann

Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Jablons, MD

Role: PRINCIPAL_INVESTIGATOR

Maestro Clinical

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Beijing Chaoyang Hospital

Beijing, , China

Site Status

Beijing Tumor Hospital

Beijing, , China

Site Status

Beijing Youyi Hospital

Beijing, , China

Site Status

China-Japan Friendship Hospital

Beijing, , China

Site Status

Xuanwu Hospital

Beijing, , China

Site Status

First Affiliated Hospital, Guangzhou Medical College

Guangzhou, , China

Site Status

Sun Yat-sen Cancer Center

Guangzhou, , China

Site Status

Shanghai Chest Hopsital, Pulmonary Medicine

Shanghai, , China

Site Status

Shanghai Lung Cancer Center, Shanghai Chest Hospital

Shanghai, , China

Site Status

Shanghai Pulmonary Hospital

Shanghai, , China

Site Status

Tianjin Cancer Center

Tianjin, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States China

References

Explore related publications, articles, or registry entries linked to this study.

Zhi X, Gao W, Han B, Yang Y, Li H, Liu D, Wang C, Min G, Long H, Rigas JR, Carey M, Jahan T, Sammann A, Reza J, Wang D, Mann MJ, Jablons DM, He J; China Clinical Trials Consortium. VATS lobectomy facilitates the delivery of adjuvant docetaxel-carboplatin chemotherapy in patients with non-small cell lung cancer. J Thorac Dis. 2013 Oct;5(5):578-84. doi: 10.3978/j.issn.2072-1439.2012.02.05.

Reference Type DERIVED
PMID: 24255769 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IIT 12230

Identifier Type: -

Identifier Source: secondary_id

MC#08-002

Identifier Type: -

Identifier Source: org_study_id