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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


Phase 2
18 Years
75 Years
Not Enrolling
Both
Non-small Cell Lung Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Event-free survival

Outcome Time Frame:

five years

Safety Issue:

No

Principal Investigator

luo qingquan, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Shanghai Chest Hospital

Authority:

China: Ethics Committee

Study ID:

chest1001

NCT ID:

NCT01187290

Start Date:

August 2010

Completion Date:

June 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Preoperative chemoradiotherapy
  • stage IIIA, N2
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasm Metastasis

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