search
Back to results

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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Hyperfractionated
Taxotere/Cisplatin
conventional surgery
Sponsored by
Swiss Group for Clinical Cancer Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring squamous cell lung cancer, large cell lung cancer, stage IIIB non-small cell lung cancer, adenosquamous cell lung cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire Vaudois

Outcomes

Primary Outcome Measures

Rate of event-free survival measured 1 year after registration

Secondary Outcome Measures

Operability after chemotherapy
Postoperative mortality 30 days after surgery
Complete resection rate after surgery
Toxicity
Response rate

Full Information

First Posted
February 14, 2002
Last Updated
May 13, 2019
Sponsor
Swiss Group for Clinical Cancer Research
search

1. Study Identification

Unique Protocol Identification Number
NCT00030810
Brief Title
Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB NSCLC
Official Title
Preoperative Chemoradiotherapy In Non-Small Cell Lung Cancer (NSCLC) Patients With Operable Stage IIIB Disease: A Prospective Phase II Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Group for Clinical Cancer Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
squamous cell lung cancer, large cell lung cancer, stage IIIB non-small cell lung cancer, adenosquamous cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
Hyperfractionated
Intervention Description
Hyperfractionated radiotherapy
Intervention Type
Drug
Intervention Name(s)
Taxotere/Cisplatin
Intervention Description
Taxotere/Cisplatin
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Description
conventional surgery
Primary Outcome Measure Information:
Title
Rate of event-free survival measured 1 year after registration
Secondary Outcome Measure Information:
Title
Operability after chemotherapy
Title
Postoperative mortality 30 days after surgery
Title
Complete resection rate after surgery
Title
Toxicity
Title
Response rate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Stupp, MD
Organizational Affiliation
Centre Hospitalier Universitaire Vaudois
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
19604722
Citation
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.
Results Reference
result
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): A-18021, 685s, 2007.
Results Reference
result
PubMed Identifier
30267838
Citation
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.
Results Reference
result
PubMed Identifier
27358380
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs