Preoperative Chemoradiotherapy vs. Chemotherapy Alone in NSCLC Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT00030771
First received: February 14, 2002
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: Chemotherapy
Radiation: Radiotherapy
Procedure: Surgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Preoperative Chemoradiotherapy vs. Chemotherapy Alone in Non-small Cell Lung Cancer (NSCLC) Patients With Mediastinal Lymph Node Metastases (Stage IIIA, N2): A Randomized Prospective Phase III Trial

Resource links provided by NLM:


Further study details as provided by Swiss Group for Clinical Cancer Research:

Primary Outcome Measures:
  • Event-free survival [ Time Frame: 1 month after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Postoperative mortality assessed [ Time Frame: 1 month after surgery ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: During treatment ] [ Designated as safety issue: Yes ]
  • Complete resection rate after surgery [ Time Frame: 1 month after surgery ] [ Designated as safety issue: No ]
  • Objective response rate measured after completion of chemoradiotherapy [ Time Frame: 43 days ] [ Designated as safety issue: No ]
  • Operability [ Time Frame: 1 month after chemo ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Follow-up until death of patient ] [ Designated as safety issue: Yes ]
  • Failure pattern [ Time Frame: Follow-up until death ] [ Designated as safety issue: No ]

Enrollment: 232
Study Start Date: April 2001
Estimated Study Completion Date: January 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A
Neoadjuvant Chemoradiotherapy + Chemotherapy + Surgery
Drug: Chemotherapy
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
Radiation: Radiotherapy
Radiotherapy (3 weeks after last chemotherapy administration) 44 Gy in 22 fractions concomitant boost technique in 3 weeks
Procedure: Surgery
3-4 weeks after termination of radiotherapy
Active Comparator: Arm B
Neoadjuvant Chemotherapy + Surgery
Drug: Chemotherapy
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
Procedure: Surgery
3-4 weeks after termination of radiotherapy

Detailed Description:

The main objective of this trial is to compare feasibility and efficacy of sequential neoadjuvant chemoradiotherapy with 44 Gy concomitant boost to neoadjuvant chemotherapy alone.

Secondary objectives are to assess the value of PET in predicting pathological response and eventfree survival in stage IIIA NSCLC, and a health economic analysis of the two regimens. Further to compare the amount of serum DNA in patients with stage IIIA, pN2 NSCLC before chemotherapy, before surgery and at the second follow-up visit (i.e. four months after surgery or treatment failure for patients who can not be operated) in patients randomized into the trial SAKK 16/00 and to correlate the DNA variation with tumor response, remission duration and overall survival.

OUTLINE: This is a prospective randomized phase III trial. Patients are stratified according to mediastinal bulk (5 cm or more vs less than 5 cm), weight loss in the past 6 months (5% or more vs less than 5%), and participating center. Patients are randomized to 1 of 2 treatment arms.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00030771

Locations
Germany
Klinik Loewenstein gGmbH
Loewenstein, Germany, 74245
Klinikum der Stadt Mannheim
Mannheim, Germany, D-68135
Serbia
Institut za plucne bolesti
Sremska Kamenica, Serbia, 21204
Institute of Oncology
Sremska Kamenica, Serbia, 21204
Switzerland
Kantonsspital Aarau
Aarau, Switzerland, CH-5001
Kantonsspital Baden
Baden, Switzerland, CH-5404
Kantonsspital
Baden, Switzerland, CH-5404
Saint Claraspital AG
Basel, Switzerland, CH-4016
Universitaetsspital-Basel
Basel, Switzerland, CH-4031
Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli
Bellinzona, Switzerland, 6500
Inselspital Bern
Bern, Switzerland, CH-3010
Kantonsspital Bruderholz
Bruderholz, Switzerland, CH-4101
Kantonsspital Graubuenden
Chur, Switzerland, CH-7000
Kantonsspital Freiburg
Freiburg, Switzerland, 1708
Hopital Cantonal Universitaire de Geneve
Geneva, Switzerland, CH-1211
Centre Pluridisciplinaire d' Oncologie
Lausanne, Switzerland, 1011
Kantonsspital Liestal
Liestal, Switzerland, CH-4410
Kantonsspital Olten
Olten, Switzerland, CH-4600
FMH Onkologie/Haematologie
Rheinfelden, Switzerland, 4310
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
Regionalspital
Thun, Switzerland, 3600
Kantonsspital Winterthur
Winterthur, Switzerland, CH-8400
City Hospital Triemli
Zurich, Switzerland, CH-8063
UniversitaetsSpital Zuerich
Zurich, Switzerland, CH-8091
Onkozentrum
Zurich, Switzerland, 8038
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
Study Chair: Miklos Pless, MD Kantonsspital Winterthur KSW
Principal Investigator: Hans-Beat Ris, MD Centre Hospitalier Universitaire Vaudois
Principal Investigator: Diana Naehrig, MD Universitaetsspital-Basel
Principal Investigator: Roger Stupp, MD Centre Hospitalier Universitaire Vaudoise
  More Information

Publications:
Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT00030771     History of Changes
Other Study ID Numbers: SAKK 16/00, SWS-SAKK-16/00, EU-20138
Study First Received: February 14, 2002
Last Updated: December 12, 2013
Health Authority: Switzerland: Swissmedic / Swiss Federal Health Office

Keywords provided by Swiss Group for Clinical Cancer Research:
squamous cell lung cancer
large cell lung cancer
stage IIIA non-small cell lung cancer
adenosquamous cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014