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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

Phase 3
18 Years
75 Years
Open (Enrolling)
Lung Cancer

Thank you

Trial Information

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

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

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.

Inclusion Criteria


- 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



- 18 to 75

Performance status:

- WHO 0-1

Life expectancy:

- Not specified


- WBC at least 4,000/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin normal

- AST/ALT no greater than 1.5 times upper limit of normal (ULN)

- Alkaline phosphatase no greater than 2.5 times ULN


- Creatinine clearance greater than 60 mL/min


- 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


- Lung function appropriate


- No history of significant neurologic or psychiatric disorders

- No psychotic disorders

- No dementia

- No seizures


- 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


Biologic therapy:

- Not specified


- 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)


- No prior radiotherapy to chest


- Not specified


- At least 30 days since participation in another clinical study

- No other concurrent experimental drugs

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event-free survival

Outcome Time Frame:

1 month after surgery

Safety Issue:


Principal Investigator

Miklos Pless, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Kantonsspital Winterthur KSW


Switzerland: Swissmedic / Swiss Federal Health Office

Study ID:

SAKK 16/00



Start Date:

April 2001

Completion Date:

September 2013

Related Keywords:

  • Lung Cancer
  • squamous cell lung cancer
  • large cell lung cancer
  • stage IIIA non-small cell lung cancer
  • adenosquamous cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms