Preoperative Chemoradiotherapy Versus Chemotherapy Alone in Nonsmall Cell Lung Cancer (NSCLC) Patients With Mediastinal Lymph Node Metastases

Preoperative Chemoradiotherapy vs. Chemotherapy Alone in Nonsmall Cell Lung Cancer (NSCLC) Patients With Mediastinal Lymph Node Metastases (Stage IIIA, N2): A Randomized Prospective Phase II Trial

The main objective of this trial is to compare feasibility and efficacy of sequential neoadjuvant chemoradiotherapy with 44Gy concomitant boost to neoadjuvant chemotherapy alone. Secondary objectives are to assess the value of position emission tomography (PET）in predicting pathological response and event-free survival（EFS）in stage IIIA non-small cell lung cancer (NSCLC). Further to compare the amount of serum DNA in patients with stage IIIa NSCLC before, during and after chemotherapy, before and after radiotherapy (in arm A) and during follow-up in patients randomized into the trial and to correlate the Deoxyribonucleic acid (DNA) variation with tumor response, remission duration and overall survival.

Study Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer
• Intervention / Treatment: Radiation: neoadjuvant chemoradiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2

Contacts and Locations

Participation Criteria

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:

• Histologically proven NSCLC with nodal metastases: T1-3N2M0
• Performance status 0-1
• Patient medically fit enough for protocol therapy, including operability
• Age 18-75
• Written informed consent
• No previous chemo- or radiotherapy

Exclusion Criteria:

• Patients with prior or concomitant malignancies Allowed are: non-melanomatous skin cancer, adequately treated in situ cervical cancer or any other neoplastic diseases with disease-free interval ³ 5 years.
• Presence or history of any distant metastasis
• Unstable cardiac disease requiring treatment, congestive heart failure or angina pectoris even if medically controlled, significant arrhythmia, or prior history of myocardial infarction in the last 3 months
• History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent
• Active uncontrolled infection
• Uncontrolled diabetes mellitus
• Gastric ulcers
• Preexisting peripheral neuropathy (> grade 1)
• Other serious underlying medical condition which could impair the ability of the patient to participate in the trial
• Concurrent treatment with other experimental drugs
• Pretreatment with any other cytostatic therapy
• Previous radiotherapy to the chest
• Concurrent treatment with prednisone (or equivalent) except: for the prophylactic medication regimen before treatment, treatment of acute hypersensitivity reactions or chronic treatment (initiated > 6 months prior to trial entry) at low dose (£ 20 mg methylprednisolone or equivalent)
• Definite contraindications for the use of corticosteroids as premedication
• Treatment within a clinical trial within 30 days prior to trial entry
• Socioeconomic or geographic circumstances that may prohibit proper staging, treatment or follow-up procedures
• Pregnancy, lactation period

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: neoadjuvant chemotherapy; Chemotherapy Docetaxel 75 mg/m2 1 hour iv infusion d1 Cisplatin 100 mg/m2 1 hour iv infusion d1 Schedule: 3 cycles repeated every 21 days	Radiation: neoadjuvant chemoradiotherapy; Radiotherapy (3 weeks after last chemotherapy administration) 44 Gy in 22 fractions concomitant boost technique in 3 weeks
Experimental: neoadjuvant chemoradiotherapy; Docetaxel 75 mg/m2 1 hour iv infusion d1 Cisplatin 100 mg/m2 1 hour iv infusion d1 Schedule: 3 cycles repeated every 21 days	Radiation: neoadjuvant chemoradiotherapy; Radiotherapy (3 weeks after last chemotherapy administration) 44 Gy in 22 fractions concomitant boost technique in 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Event-free survival	five years

Secondary Outcome Measures

Outcome Measure	Time Frame
Operability	within the first 30 days (plus or minus 3 days) after surgery
Postoperative 30-day mortality	30 days after treatment
Toxicity	30 days after treatment

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Study Chair: luo qingquan, M.D., Shanghai Chest Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: August 19, 2010
• First Submitted That Met QC Criteria: August 23, 2010
• First Posted (Estimate): August 24, 2010

Study Record Updates

• Last Update Posted (Estimate): August 24, 2010
• Last Update Submitted That Met QC Criteria: August 23, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Preoperative chemoradiotherapy; stage IIIA, N2
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Lymphatic Metastasis
• Other Study ID Numbers: chest1001