Chemotherapy With or Without Radiation Therapy Before Surgery in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer - Full Text View

Sponsored by:	Swiss Group for Clinical Cancer Research
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00030771

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed. It is not yet known if chemotherapy plus radiation therapy is more effective than chemotherapy alone before surgery in treating non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy with or without radiation therapy followed by surgery in treating patients who have non-small cell lung cancer that has spread to lymph nodes in the chest.

Condition	Intervention	Phase
Lung Cancer	Drug: cisplatin Drug: docetaxel Procedure: conventional surgery Procedure: laboratory biomarker analysis Procedure: neoadjuvant therapy Procedure: radiation therapy	Phase III

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Cisplatin Docetaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	Preoperative Chemoradiotherapy Vs. Chemotherapy Alone In Non-Small Cell Lung Cancer (NSCLC) Patients With Mediastinal Lymph Node Metastases (Stage IIIA, N2): A Randomized Prospective Phase III Trial

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Event-free survival [ Designated as safety issue: No ]
Operability after chemotherapy [ Designated as safety issue: No ]

Secondary Outcome Measures:

Postoperative mortality assessed 30 days after surgery [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Complete resection rate after surgery [ Designated as safety issue: No ]
Objective response rate measured after completion of chemoradiotherapy [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	April 2001
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Compare the feasibility and efficacy of neoadjuvant chemotherapy with or without radiotherapy, in terms of event-free survival, in patients with stage IIIA non-small cell lung cancer with mediastinal lymph node metastases.
Determine the value of positron emission tomography scans for predicting pathological response and event-free survival in patients treated with these regimens.
Compare the toxicity of these regimens in these patients.
Compare the objective response rate, failure pattern, and overall survival in patients treated with these regimens.
Compare the amount of serum DNA of patients treated with these regimens.
Correlate the DNA variation with tumor response, remission duration, and overall survival.
Evaluate specific serum DNA markers (i.e., beta-tubulin-, p53-, ras-mutation, DAP kinase-, CDKN2 hypermethylation present in the primary tumors) for predictivity.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to mediastinal bulk (5 cm or more vs less than 5 cm), weight loss in the past 6 months (5% or more vs less than 5%), and participating center. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive docetaxel IV over 1 hour followed by cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Three weeks after the last chemotherapy administration, patients undergo radiotherapy once daily 5 days a week for 3 weeks and boost radiotherapy on days 2, 5, 9, 12, 15, 17, and 19 during the same 3 weeks.
Arm II: Patients receive chemotherapy as in arm I. All patients undergo surgical resection and mediastinal lymph node dissection within 21-28 days after completion of radiotherapy (arm I) or within 21 days after completion of chemotherapy (arm II).

All patients undergo blood collection periodically for translational research studies.

Patients are followed at 1 month and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 120 patients (60 per treatment arm) will be accrued for this study within 4 years.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed non-small cell lung cancer
- Squamous, adenosquamous, large cell, or poorly differentiated
Stage IIIA (T1-3, N2, M0)
- N2 disease confirmed by 1 of the following:
  - Mediastinoscopy
  - Bronchoscopy with fine-needle aspiration or esophagoscopy
    - All N3 lymph nodes must be negative by positron-emission tomography (PET) AND CT scan (< 1 cm in the largest diameter)
  - PET scan
    - Both the primary tumor and at least 1 N2 lymph node must be positive in PET scan
    - At least 1 of the PET scan positive N2 lymph nodes is positive in the CT scan (> 1 cm in the largest diameter)
    - All N3 lymph nodes negative in PET scan

PATIENT CHARACTERISTICS:

Age:

18 to 75

Performance status:

WHO 0-1

Life expectancy:

Not specified

Hematopoietic:

WBC at least 4,000/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Bilirubin normal
AST/ALT no greater than 1.5 times upper limit of normal (ULN)
Alkaline phosphatase no greater than 2.5 times ULN

Renal:

Creatinine clearance greater than 60 mL/min

Cardiovascular:

Cardiac function normal
No unstable cardiac disease requiring treatment
No congestive heart failure
No angina pectoris even if medically controlled
No significant arrhythmia
No myocardial infarction in the past 3 months

Pulmonary:

Lung function appropriate

Neurologic:

No history of significant neurologic or psychiatric disorders
No psychotic disorders
No dementia
No seizures

Other:

No other prior or concurrent malignancies except nonmelanoma skin cancer, adequately treated carcinoma in situ of the cervix, or any other neoplastic disease with a disease-free interval ≥ 5 years
No active uncontrolled infection
No uncontrolled diabetes mellitus
No gastric ulcers
No pre-existing peripheral neuropathy greater than grade 1
No contraindications to corticosteroids
No other serious underlying medical condition that would preclude study participation
No socioeconomic or geographic condition that would preclude study participation
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior cytostatic chemotherapy

Endocrine therapy:

No concurrent prednisone except for treatment of acute hypersensitivity reactions or chronic low-dose treatment initiated more than 6 months prior to study entry (i.e., no greater than 20 mg methylprednisolone or equivalent)

Radiotherapy:

No prior radiotherapy to chest

Surgery:

Not specified

Other:

At least 30 days since participation in another clinical study
No other concurrent experimental drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00030771

Locations

Switzerland
Hopital Cantonal Universitaire de Geneve	Recruiting
Geneva, Switzerland, CH-1211
Contact: Arnaud Roth, MD 41-22-372-7744 arnaud.roth@sim.hcuge.ch
Inselspital Bern	Recruiting
Bern, Switzerland, CH-3010
Contact: Adrian Ochsenbein, MD 41-31-632-8169 adrian.ochsenbein@insel.ch
Kantonspital Aarau	Recruiting
Aarau, Switzerland, CH-5001
Contact: Walter Mingrone, MD 41-62-838-6050
Kantonsspital Baden	Recruiting
Baden, Switzerland, CH-5404
Contact: Clemens B. Caspar, MD 41-56-486-2511
Kantonsspital Bruderholz	Recruiting
Bruderholz, Switzerland, CH-4101
Contact: Lorenz M. Jost, MD 41-61-436-3636 lorenz.jost@ksbh.ch
Universitaetsspital-Basel	Recruiting
Basel, Switzerland, CH-4031
Contact: Cornelia Droege, MD 41-61-265-5075 cdroege@uhbs.ch
Kantonsspital Winterthur	Recruiting
Winterthur, Switzerland, CH-8401
Contact: Miklos Pless, MD 41-52-266-2552 miklos.pless@ksw.ch
Regionalspital	Recruiting
Thun, Switzerland, 3600
Contact: Daniel Rauch 41-33-226-2626
Saint Claraspital AG	Recruiting
Basel, Switzerland, CH-4016
Contact: Christian U. Ludwig, MD 41-61-691-8585 christian.ludwig@claraspital.ch
	Recruiting
Baden, Switzerland, CH-5404
Contact: Antoinette Streit, MD 41-56-221-1474
Kantonsspital Liestal	Recruiting
Liestal, Switzerland, CH-4410
Contact: Andreas Lohri, MD 41-61-925-2710 andreas.lohri@ksli.ch

Sponsors and Collaborators

Swiss Group for Clinical Cancer Research

Investigators

Study Chair:

Miklos Pless, MD

Kantonsspital Winterthur

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000069196, SWS-SAKK-16/00, EU-20138
Study First Received:	February 14, 2002
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00030771
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

squamous cell lung cancer
large cell lung cancer
stage IIIA non-small cell lung cancer
adenosquamous cell lung cancer

Study placed in the following topic categories:

Docetaxel
Thoracic Neoplasms
Non-small cell lung cancer
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms

Lung Diseases
Neoplasm Metastasis
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 15, 2009