Trial of Either Surgery or Stereotactic Radiotherapy for Early Stage (IA) Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-02-28

Brief Summary

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The standard treatment for an early stage I lung cancer is surgery. However, surgery can be associated with complications and long-term impairment of the quality of life of patients. Stereotactic radiotherapy (SRT) is a outpatient technique which allows for local control rates that are comparable to those achieved using surgery. In this study, patients with stage IA non-small cell lung cancer will be randomized to either surgery or SRT in order to study the local and regional tumor control, quality of life and treatment costs at 2- and 5-years.

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Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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primary surgery

primary surgical resection

Group Type ACTIVE_COMPARATOR

primary surgery

Intervention Type PROCEDURE

an anatomical surgical resection with lymph node dissection

stereotactic radiotherapy

primary stereotactic radiotherapy

Group Type EXPERIMENTAL

stereotactic radiotherapy

Intervention Type RADIATION

Either 3 fractions of 20 Gray or 5 fractions of 12 Gy

Interventions

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stereotactic radiotherapy

Either 3 fractions of 20 Gray or 5 fractions of 12 Gy

Intervention Type RADIATION

primary surgery

an anatomical surgical resection with lymph node dissection

Intervention Type PROCEDURE

Other Intervention Names

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radiotherapy operation

Eligibility Criteria

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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 disease).
* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No