- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00030810
Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB NSCLC
Preoperative Chemoradiotherapy In Non-Small Cell Lung Cancer (NSCLC) Patients With Operable Stage IIIB Disease: A Prospective Phase II Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Lausanne, Switzerland, CH-1011
- Centre Hospitalier Universitaire Vaudois
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Rate of event-free survival measured 1 year after registration
|
Secondary Outcome Measures
Outcome Measure |
---|
Toxicity
|
Response rate
|
Operability after chemotherapy
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Postoperative mortality 30 days after surgery
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Complete resection rate after surgery
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Fruh 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 Group for Clinical Cancer Research (SAKK). Multimodal Treatment in Operable Stage III NSCLC: A Pooled Analysis on Long-Term Results of Three SAKK trials (SAKK 16/96, 16/00, and 16/01). J Thorac Oncol. 2019 Jan;14(1):115-123. doi: 10.1016/j.jtho.2018.09.011. Epub 2018 Sep 26.
- 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. doi: 10.1016/S1470-2045(09)70172-X. 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.
- Fruh 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):1971-3. doi: 10.1093/annonc/mdw251. Epub 2016 Jun 29. No abstract available.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAKK 16/01
- EU-20137
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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