To hear about similar clinical trials, please enter your email below
Trial Title:
Preoperative Chemoradiotherapy Versus Chemotherapy Alone in Nonsmall Cell Lung Cancer (NSCLC) Patients With Mediastinal Lymph Node Metastases
NCT ID:
NCT01187290
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Lymphatic Metastasis
Conditions: Keywords:
Preoperative chemoradiotherapy
stage IIIA, N2
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
neoadjuvant chemoradiotherapy
Description:
Radiotherapy (3 weeks after last chemotherapy administration) 44 Gy in 22 fractions
concomitant boost technique in 3 weeks
Arm group label:
neoadjuvant chemoradiotherapy
Arm group label:
neoadjuvant chemotherapy
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
August 2010
Completion date:
June 2013
Lead sponsor:
Agency:
Shanghai Jiao Tong University School of Medicine
Agency class:
Other
Source:
Shanghai Jiao Tong University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01187290
