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

NCT00030810 | Completed Phase 2 DMC

• 2 other identifiers: SAKK 16/01EU-20137
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Rate of event-free survival measured 1 year after registration

Secondary Outcomes (5)

• Operability after chemotherapy

• Postoperative mortality 30 days after surgery

• Complete resection rate after surgery

• Toxicity

• Response rate

Interventions

Hyperfractionated RADIATION

Hyperfractionated radiotherapy

Taxotere/Cisplatin DRUG

Taxotere/Cisplatin

conventional surgery PROCEDURE

conventional surgery

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Related Publications (4)

• 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.

  PMID: 19604722 RESULT

• 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.

  RESULT

• 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.

  PMID: 30267838 RESULT

• 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.

  PMID: 27358380 RESULT

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel; Cisplatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Roger Stupp, MD

  Centre Hospitalier Universitaire Vaudois

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2002
• First Posted: January 27, 2003
• Study Start: September 1, 2001
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: May 15, 2019

Record last verified: 2019-05

Locations

CH (1)