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

Non-small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01187290
• Other study ID #: chest1001
• Status: Not yet recruiting
• Phase: Phase 2
• First received: August 19, 2010
• Last updated: August 23, 2010
• Start date: August 2010
• Est. completion date: June 2013

Study information

• Verified date: August 2010
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Luo qingquan, M.D
• Phone: 86-21-62821990
• Email: liziming1980[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Radiation:
• neoadjuvant chemoradiotherapy
Radiotherapy (3 weeks after last chemotherapy administration) 44 Gy in 22 fractions concomitant boost technique in 3 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free survival		five years	No
Secondary	Operability		within the first 30 days (plus or minus 3 days) after surgery	No
Secondary	Postoperative 30-day mortality		30 days after treatment	Yes
Secondary	Toxicity		30 days after treatment	Yes