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

NCT01187290 | Unknown Phase 2 DMC

• 1 other identifier: chest1001
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer

Keywords

Preoperative chemoradiotherapy; stage IIIA, N2

Outcome Measures

Primary Outcomes (1)

• Event-free survival

  five years

Secondary Outcomes (3)

• 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

Study Arms (2)

neoadjuvant chemotherapy

NO INTERVENTION

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

neoadjuvant chemoradiotherapy

EXPERIMENTAL

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

Interventions

neoadjuvant chemoradiotherapy RADIATION

Radiotherapy (3 weeks after last chemotherapy administration) 44 Gy in 22 fractions concomitant boost technique in 3 weeks

neoadjuvant chemoradiotherapy; neoadjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• luo qingquan, M.D.

  Shanghai Chest Hospital

  STUDY CHAIR

Central Study Contacts

Luo qingquan, M.D

CONTACT

86-21-62821990; liziming1980@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: August 24, 2010
• Study Start: August 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: August 24, 2010

Record last verified: 2010-08