Preoperative Chemoradiotherapy vs. Chemotherapy Alone in NSCLC Patients

NCT00030771 | Completed Phase 3 DMC

• 3 other identifiers: SAKK 16/00SWS-SAKK-16/00EU-20138
• Study Type: interventional
• Target: 232
• Locations: 3 countries
• Sites: 25

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, 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. Giving chemotherapy with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known if chemotherapy plus radiation therapy is more effective than chemotherapy alone before surgery in treating non-small cell lung cancer. PURPOSE: This randomized phase III trial is studying docetaxel and cisplatin with or without radiation therapy to see how well they work when given before surgery in treating patients with stage IIIA non-small cell lung cancer that has spread to lymph nodes in the chest.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Event-free survival

  Time from randomization to relapse/progression/second tumor/death, whichever occurs first (for all randomized patients). If no event is observed, the patients will be censored at the last time they were known to be alive.

  1 month after surgery

Secondary Outcomes (7)

• Postoperative mortality assessed

  1 month after surgery

• Toxicity (hematological, renal and neurological toxicities, nausea and vomiting, weight changes as well as esophageal toxicities)

  During treatment

• Complete resection rate after surgery

  1 month after surgery

• Objective response rate measured after completion of chemoradiotherapy

  43 days

• Operability

  1 month after chemo

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Neoadjuvant Chemoradiotherapy + Chemotherapy + Surgery

Drug: Chemotherapy; Radiation: Radiotherapy; Procedure: Surgery

Arm B

ACTIVE COMPARATOR

Neoadjuvant Chemotherapy + Surgery

Drug: Chemotherapy; Procedure: Surgery

Interventions

Chemotherapy DRUG

Docetaxel (Taxotere®) 85 mg/m2 1 hour iv infusion d1 Cisplatin 100 mg/m2 1 hour iv infusion d1 Schedule: 3 cycles repeated every 21 days

Arm A; Arm B

Radiotherapy RADIATION

Radiotherapy (3 weeks after last chemotherapy administration) 44 Gy in 22 fractions concomitant boost technique in 3 weeks

Arm A

Surgery PROCEDURE

3-4 weeks after termination of radiotherapy

Arm A; Arm B

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer * Squamous, adenosquamous, large cell, or poorly differentiated * Stage IIIA (T1-3, N2, M0) * N2 disease confirmed by 1 of the following: * Mediastinoscopy * Bronchoscopy with fine-needle aspiration or esophagoscopy * All N3 lymph nodes must be negative by positron-emission tomography (PET) AND CT scan (\< 1 cm in the largest diameter) * PET scan * Both the primary tumor and at least 1 N2 lymph node must be positive in PET scan * At least 1 of the PET scan positive N2 lymph nodes is positive in the CT scan (\> 1 cm in the largest diameter) * All N3 lymph nodes negative in PET scan 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/ALT no greater than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine clearance greater than 60 mL/min Cardiovascular: * Cardiac function normal * No unstable cardiac disease requiring treatment * No congestive heart failure * No angina pectoris even if medically controlled * No significant arrhythmia * No myocardial infarction in the past 3 months Pulmonary: * Lung function appropriate Neurologic: * No history of significant neurologic or psychiatric disorders * No psychotic disorders * No dementia * No seizures Other: * No other prior or concurrent malignancies except nonmelanoma skin cancer, adequately treated carcinoma in situ of the cervix, or any other neoplastic disease with a disease-free interval ≥ 5 years * No active uncontrolled infection * No uncontrolled diabetes mellitus * No gastric ulcers * No pre-existing peripheral neuropathy greater than grade 1 * No contraindications to corticosteroids * No other serious underlying medical condition that would preclude study participation * No socioeconomic or geographic condition that would preclude study participation * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior cytostatic chemotherapy Endocrine therapy: * No concurrent prednisone except for treatment of acute hypersensitivity reactions or chronic low-dose treatment initiated more than 6 months prior to study entry (i.e., no greater than 20 mg methylprednisolone or equivalent) Radiotherapy: * No prior radiotherapy to chest Surgery: * Not specified Other: * At least 30 days since participation in another clinical study * 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 (25)

Klinik Loewenstein gGmbH

Löwenstein, 74245, Germany

Location

Klinikum der Stadt Mannheim

Mannheim, D-68135, Germany

Location

Institut za plucne bolesti

Kamenitz, 21204, Serbia

Location

Institute of Oncology

Kamenitz, 21204, Serbia

Location

Kantonsspital Aarau

Aarau, CH-5001, Switzerland

Location

Kantonsspital Baden

Baden, CH-5404, Switzerland

Location

Kantonsspital

Baden, CH-5404, Switzerland

Location

Saint Claraspital AG

Basel, CH-4016, Switzerland

Location

Universitaetsspital-Basel

Basel, CH-4031, Switzerland

Location

Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli

Bellinzona, 6500, Switzerland

Location

Inselspital Bern

Bern, CH-3010, Switzerland

Location

Kantonsspital Bruderholz

Bruderholz, CH-4101, Switzerland

Location

Kantonsspital Graubuenden

Chur, CH-7000, Switzerland

Location

Kantonsspital Freiburg

Fribourg, 1708, Switzerland

Location

Hopital Cantonal Universitaire de Geneve

Geneva, CH-1211, Switzerland

Location

Centre Pluridisciplinaire d' Oncologie

Lausanne, 1011, Switzerland

Location

Kantonsspital Liestal

Liestal, CH-4410, Switzerland

Location

Kantonsspital Olten

Olten, CH-4600, Switzerland

Location

FMH Onkologie/Haematologie

Rheinfelden, 4310, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Regionalspital

Thun, 3600, Switzerland

Location

Kantonsspital Winterthur

Winterthur, CH-8400, Switzerland

Location

Onkozentrum

Zurich, 8038, Switzerland

Location

City Hospital Triemli

Zurich, CH-8063, Switzerland

Location

UniversitaetsSpital Zuerich

Zurich, CH-8091, Switzerland

Location

Related Publications (2)

• Tieu BH, Sanborn RE, Thomas CR Jr. Neoadjuvant therapy for resectable non-small cell lung cancer with mediastinal lymph node involvement. Thorac Surg Clin. 2008 Nov;18(4):403-15. doi: 10.1016/j.thorsurg.2008.07.004.

  PMID: 19086609 BACKGROUND

• Pless M, Stupp R, Ris HB, Stahel RA, Weder W, Thierstein S, Gerard MA, Xyrafas A, Fruh M, Cathomas R, Zippelius A, Roth A, Bijelovic M, Ochsenbein A, Meier UR, Mamot C, Rauch D, Gautschi O, Betticher DC, Mirimanoff RO, Peters S; SAKK Lung Cancer Project Group. Induction chemoradiation in stage IIIA/N2 non-small-cell lung cancer: a phase 3 randomised trial. Lancet. 2015 Sep 12;386(9998):1049-56. doi: 10.1016/S0140-6736(15)60294-X. Epub 2015 Aug 11.

  PMID: 26275735 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Drug Therapy; Radiotherapy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Miklos Pless, MD

  Kantonsspital Winterthur KSW

  STUDY CHAIR

• Hans-Beat Ris, MD

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

• Diana Naehrig, MD

  Universitaetsspital-Basel

  PRINCIPAL INVESTIGATOR

• Roger Stupp, MD

  Centre Hospitalier Universitaire Vaudoise

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2002
• First Posted: January 27, 2003
• Study Start: April 4, 2001
• Primary Completion: April 9, 2014
• Study Completion: September 15, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); SE (2); CH (21)