Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB NSCLC

Lung Cancer Clinical Trial

Official title:

Preoperative Chemoradiotherapy In Non-Small Cell Lung Cancer (NSCLC) Patients With Operable Stage IIIB Disease: A Prospective Phase II Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00030810
• Other study ID #: SAKK 16/01
• Secondary ID: EU-20137
• Status: Completed
• Phase: Phase 2
• Start date: September 2001
• Est. completion date: May 2006

Study information

• Verified date: May 2019
• Source: Swiss Group for Clinical Cancer Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Radiation:
• Hyperfractionated
Hyperfractionated radiotherapy

Drug:
• Taxotere/Cisplatin
Taxotere/Cisplatin

Procedure:
• conventional surgery
conventional surgery

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Group for Clinical Cancer Research

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

Früh M, Betticher DC, Stupp R, Xyrafas A, Peters S, Ris HB, Mirimanoff RO, Ochsenbein AF, Schmid R, Matzinger O, Stahel RA, Weder W, Guckenberger M, Rothschild SI, Lardinois D, Mach N, Mark M, Gautschi O, Thierstein S, Biaggi Rudolf C, Pless M; Swiss Grou — View Citation

Früh M, Ris HB, Xyrafas A, Peters S, Mirimanoff RO, Gautschi O, Pless M, Stupp R. Preoperative chemoradiotherapy with cisplatin and docetaxel for stage IIIB non-small-cell lung cancer: 10-year follow-up of the SAKK 16/01 trial. Ann Oncol. 2016 Oct;27(10): — View Citation

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

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of event-free survival measured 1 year after registration
Secondary	Operability after chemotherapy
Secondary	Postoperative mortality 30 days after surgery
Secondary	Complete resection rate after surgery
Secondary	Toxicity
Secondary	Response rate