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A Randomized Clinical Trial of Surgery Versus Radiosurgery (Stereotactic Radiotherapy) in Patients With Stage IA NSCLC Who Are Fit to Undergo Primary Resection

Phase 3
18 Years
Not Enrolling
Lung Cancer

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Trial Information

A Randomized Clinical Trial of Surgery Versus Radiosurgery (Stereotactic Radiotherapy) in Patients With Stage IA NSCLC Who Are Fit to Undergo Primary Resection

Inclusion Criteria:

- Patients with a cytological or histological diagnosis of stage IA non-cell lung
cancer diagnosed in accordance with Dutch CBO guidelines [2004]. When no
pathological diagnosis is available, a patient with a new or growing pulmonary lesion
with radiological features consistent with malignancy AND a lesion showing uptake on
a FDG-PET scan will be eligible [Herder 2005].

- No evidence of regional or distant metastases on a standardized FDG-PET scan within 6
weeks of any protocol treatment .

- The medial extension of tumors should be least 2 cm away from main and lobar bronchi,
and also minimum of 1.5 cm from large peripheral blood vessels such as the aorta and
main pulmonary artery. Lesions of at least 2 cm from the mediastinal pleura will be
eligible if the responsible radiation oncologist judges that the specified normal
tissue tolerance doses specified in the protocol will not be exceeded.

- Patients who are judged by a multi-disciplinary team to have 2 primary lung tumors
(on the basis of clinical, radiological, FDG-PET and/or cyto-pathology findings) are
eligible for randomization provided that both surgery and SRT can be performed in
accordance with protocol requirements.

- Patient should be fit to undergo a complete surgical resection of the lesion in
accordance with Dutch CBO guidelines [2004]

- Performance score of ECOG ≤ 2 before any treatment.

- Able to comply with post-treatment follow-up

- Patients must sign and date a written Independent Ethics Committee approved informed
consent form.

Exclusion Criteria:

- Prior chemotherapy or radiotherapy for the present diagnosis of NSCLC.

- History of any active malignancy (other than NSCLC) unless treated more than 3 years
with curative intent and no recurrence, with the exception of non-melanoma skin
cancers or in-situ cervical cancers.

- Any unstable systemic disease (including active infection, uncontrolled hypertension,
unstable angina, congestive heart failure, myocardial infarction within the previous
year, severe cardiac arrhythmia requiring medication, hepatic, renal or metabolic

- Concomitant treatment with any other experimental drug under investigation.

- Pregnancy

- Men and women of child-bearing potential not using effective means of contraception
for 6 months after treatment has been completed.

Type of Study:


Study Design:

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

Outcome Measure:

local and regional control

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Suresh Senan, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

VU University Medical Center


Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:




Start Date:

October 2008

Completion Date:

December 2015

Related Keywords:

  • Lung Cancer
  • surgery
  • stereotactic radiotherapy
  • tumor control
  • quality of life
  • Lung Neoplasms