Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer - Full Text View

Sponsor:	Swiss Group for Clinical Cancer Research
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00030810

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 during surgery.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by radiation therapy before surgery in treating patients who have stage IIIB non-small cell lung cancer.

Condition	Intervention	Phase
Lung Cancer	Drug: cisplatin Drug: docetaxel Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Preoperative Chemoradiotherapy In Non-Small Cell Lung Cancer (NSCLC) Patients With Operable Stage IIIB Disease: A Prospective Phase II Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Surgery

Drug Information available for: Cisplatin Docetaxel

U.S. FDA Resources

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

Primary Outcome Measures:

Rate of event-free survival measured 1 year after registration [ Designated as safety issue: No ]

Secondary Outcome Measures:

Operability after chemotherapy [ Designated as safety issue: No ]
Postoperative mortality 30 days after surgery [ Designated as safety issue: No ]
Complete resection rate after surgery [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]
Response rate [ Designated as safety issue: No ]

Estimated Enrollment:	46
Study Start Date:	September 2001

Detailed Description:

OBJECTIVES:

Determine the feasibility and efficacy of sequential neoadjuvant docetaxel, cisplatin, and radiotherapy followed by surgery in patients with operable stage IIIB non-small cell lung cancer.
Determine the rate of event-free survival at 1 year in patients treated with this regimen.
Determine the operability and complete resection rate in patients treated with this regimen.
Determine the postoperative 30-day mortality in patients treated with this regimen.
Determine the response rate, failure pattern, and overall survival in patients treated with this regimen.
Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of unacceptable toxicity.

Beginning 3 weeks after the last chemotherapy dose, patients without progressive disease receive radiotherapy 1-2 times daily on days 1-5, 8-12, and 15-19.

Patients undergo surgery within 3-4 weeks after completion of radiotherapy.

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

PROJECTED ACCRUAL: A total of 15-46 patients will be accrued for this study.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed, operable stage IIIB non-small cell lung cancer
- T4 N0-3 M0 or T1-4 N3 M0 by bronchoscopy and mediastinoscopy (required for assessment of N3 disease) or CT scan or MRI of the thorax
- Squamous cell
- Adenosquamous cell
- Large cell
- Poorly differentiated
No prior or concurrent metastatic disease by CT scan or MRI of the brain, bone scan, and abdominal ultrasound or CT scan
No malignant pleural or pericardial effusion
No invasion of the aorta, esophagus, myocardium, or supraclavicular nodes

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

Renal:

Creatinine clearance at least 60 mL/min

Cardiovascular:

No unstable cardiac disease requiring treatment
No congestive heart failure
No angina pectoris (even if medically controlled)
No significant arrhythmia
No myocardial infarction within the past 3 months

Other:

Not pregnant or nursing
Fertile patients must use effective contraception
No definite contraindications for the use of corticosteroids as premedication
No preexisting grade 2 or greater peripheral neuropathy
No active uncontrolled infection
No uncontrolled diabetes mellitus
No other prior or concurrent malignancy except non-melanomatous skin cancer or adequately treated carcinoma in situ of the cervix
No prior significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures that would preclude informed consent
No other serious underlying medical condition that would preclude study participation
No socioeconomic or geographical circumstances that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

Not specified

Endocrine therapy:

No concurrent corticosteroids except as prophylactic pretreatment medication, treatment for acute hypersensitivity reactions, or chronic treatment (initiated more than 6 months ago) at low-dose (no more than 20 mg methylprednisolone or equivalent)

Radiotherapy:

No prior radiotherapy to the chest

Surgery:

See Disease Characteristics

Other:

At least 30 days since prior treatment in a clinical trial
No prior cytostatic therapy
No other concurrent experimental drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00030810

Locations

Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011

Sponsors and Collaborators

Swiss Group for Clinical Cancer Research

Investigators

Study Chair:

Roger Stupp, MD

Centre Hospitalier Universitaire Vaudois

More Information

Additional Information:

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

Publications:

Stupp R, Mayer M, Kann R, Weder W, Zouhair A, Betticher DC, Roth AD, Stahel RA, Majno SB, Peters S, Jost L, Furrer M, Thierstein S, Schmid RA, Hsu-Schmitz SF, Mirimanoff RO, Ris HB, Pless M. Neoadjuvant chemotherapy and radiotherapy followed by surgery in selected patients with stage IIIB non-small-cell lung cancer: a multicentre phase II trial. Lancet Oncol. 2009 Aug;10(8):785-93. Epub 2009 Jul 13.

Pless M, Stupp R, Kann R, et al.: Preoperative chemoradiotherapy in non-small cell lung cancer (NSCLC) patients with operable stage IIIB disease: a phase II trial of the Swiss Group for Clinical Cancer Research (SAKK). [Abstract] J Clin Oncol 25 (Suppl 18): A-18021, 685s, 2007.

Study ID Numbers:	CDR0000069199, SWS-SAKK-16/01, EU-20137
Study First Received:	February 14, 2002
Last Updated:	October 29, 2009
ClinicalTrials.gov Identifier:	NCT00030810 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Carcinoma
Docetaxel
Neoplasms

Neoplasms by Site
Radiation-Sensitizing Agents
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 05, 2009