Pre-operative Chemotherapy Versus Concurrent Chemoradiotherapy in Locally Advanced Non-small Cell Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2011-12-31

Brief Summary

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

This phase II trial is to compare neoadjuvant chemotherapy with concurrent chemoradiotherapy in patients with locally advanced non-small cell lung cancer (NSCLC) to address optimal induction strategy.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Split-course Hypofractionated Radiotherapy With Concurrent Chemotherapy in Locally Advanced Non-small Cell Lung Cancer

NCT04212052

Non-small Cell Lung Cancer

COMPLETED PHASE2

A Study Evaluating Neoadjuvant Chemotherapy, Concurrent Chemoradiotherapy Combined With Dual Immune Checkpoint Blockade in Patients With Locally Advanced Non-Small Cell Lung Cancer

NCT07103395

Lung Cancer (NSCLC)

RECRUITING PHASE2

Hypofractionated Versus Conventional Chemoradiotherapy Followed by Consolidative Immunotherapy in Locally Advanced NSCLC

NCT07052669

Locally Advanced Non-Small Cell Lung Cancer

RECRUITING PHASE3

Neoadjuvant Immunotherapy Plus Chemotherapy Followed by Concurrent Chemoradiotherapy and Consolidative Immunotherapy for Locally Advanced Non-small Cell Lung Cancer

NCT06734702

Neoadjuvant Therapy Concurrent Chemoradiotherapy Immunotherapy +1 more

RECRUITING PHASE3

Study of Split-course Chemoradiotherapy For Locally Advanced None-small Cell Lung Cancer

NCT02573506

Non-small Cell Lung Cancer

COMPLETED PHASE2

Detailed Description

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

Management of locally advanced non-small cell lung cancer (NSCLC) remains a challenge. Both local relapses and distant metastases are frequent, with 5-year survival of 3-17% for inoperable disease. Staging has historically subdivided stage III disease into clinical stage IIIA, thought to be potentially amenable to surgery, and stage IIIB, treated by defi nitive radiotherapy or radiochemotherapy. This phase II trial is to compare neoadjuvant chemotherapy with concurrent chemoradiotherapy in patients with locally advanced NSCLC to address optimal induction strategy.

Conditions

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

Non-small Cell Lung Cancer

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Pre-operative chemotherapy

Docetaxel 75 mg/m2 + Carboplatin AUC(area under the curve)=6 on D1, q3 weeks, Pre-Op \& Post-Op (total 4 cycles)

Group Type EXPERIMENTAL

Pre-operative chemotherapy

Intervention Type DRUG

Docetaxel 75 mg/m2 + Carboplatin AUC(area under the curve)=6 on D1, q3 weeks, Pre-Op \& Post-Op (total 4 cycles)

Pre-operative concurrent chemoradiation therapy

Group Type ACTIVE_COMPARATOR

Pre-operative concurrent chemoradiation therapy

Intervention Type OTHER

Chemotherapy: Docetaxel 20 mg/m2 + carboplatin area under the curve = 2 on D1 and 8, q3weeks, Pre-Op \& Post-Op: 2 cycles (total 4 cycles).

Concurrent thoracic radiotherapy: Preoperative Thoracic radiation: 180cGy/fx, total: 4500cGy, 25fx

Interventions

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

Pre-operative chemotherapy

Docetaxel 75 mg/m2 + Carboplatin AUC(area under the curve)=6 on D1, q3 weeks, Pre-Op \& Post-Op (total 4 cycles)

Intervention Type DRUG

Pre-operative concurrent chemoradiation therapy

Chemotherapy: Docetaxel 20 mg/m2 + carboplatin area under the curve = 2 on D1 and 8, q3weeks, Pre-Op \& Post-Op: 2 cycles (total 4 cycles).

Concurrent thoracic radiotherapy: Preoperative Thoracic radiation: 180cGy/fx, total: 4500cGy, 25fx

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Histopathologic diagnosis of non small-cell lung cancer
* Clinical stage IIIA and/or IIIB without pleural effusion
* ECOG functional status 0 or 1
* No renal function alteration (GFR \>50%)
* No hepatic function alteration (ALT and AST less than 2 times its normal value)
* Leucocytes more than 2,000/mcl
* Hemoglobin more than 10mg/dL
* Platelets more than 100,000/mcl

Exclusion Criteria

* Active uncontrolled infection.
* Serious concomitant disorders that would compromise the safety of patient or compromise the patient's ability to tolerate therapy.
* MI within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia.
* Significant neurological or mental disorder.
* Second primary malignancy.
* Pregnant or nursing.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No