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

A Randomized Phase II Study Preoperative Chemotherapy Versus Preoperative Concurrent Chemoradiotherapy for Patients With Locally Advanced Non-Small Cell Lung Cancer

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01054482

Enrollment

120

Registered

2010-01-22

Start date

2007-02-28

Completion date

2011-12-31

Last updated

2010-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

Neoadjuvant chemotherapy, neoadjuvant chemoradiotherapy

Brief summary

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.

Detailed description

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.

Interventions

DRUGPre-operative chemotherapy

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

OTHERPre-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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
To estimate the time to recurrence	Every 3 months

Secondary

Measure	Time frame
To assess the pathologic complete response rate and the complete resection rate	Every 4 weeks
To estimate toxicities	Every 4 weeks

Countries

China

Contacts

Primary ContactJianxing He, MD, FACS

drjianxing.he@gmail.com+86-20-83337792

Backup ContactDaoyuan Wang, MD

ghealth2008@gmail.com+86-20-83337792

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026