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

Sponsor
Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Unknown status
CT.gov ID
NCT01187290
Collaborator
(none)
80
Enrollment
2
Arms
34
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: neoadjuvant chemoradiotherapy
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Aug 1, 2010
Anticipated Primary Completion Date :
Dec 1, 2012
Anticipated Study Completion Date :
Jun 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Event-free survival [five years]

Secondary Outcome Measures

  1. Operability [within the first 30 days (plus or minus 3 days) after surgery]

  2. Postoperative 30-day mortality [30 days after treatment]

  3. Toxicity [30 days after treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shanghai Jiao Tong University School of Medicine

Investigators

  • Study Chair: luo qingquan, M.D., Shanghai Chest Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01187290
Other Study ID Numbers:
  • chest1001
First Posted:
Aug 24, 2010
Last Update Posted:
Aug 24, 2010
Last Verified:
Aug 1, 2010
Keywords provided by , ,
Preoperative chemoradiotherapy
stage IIIA, N2
Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Lymphatic Metastasis

Study Results

No Results Posted as of Aug 24, 2010