CompletedNot Applicable

Radiation in Stage I or Stage II Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

Canada80 participantsStarted 2006-08-02

Plain-language summary

RATIONALE: Radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This phase II trial is studying how well radiation therapy works in treating patients with stage I or stage II non-small cell lung cancer that cannot be removed by surgery.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) * Stage I or II peripheral disease * T1, N0, M0 * T2 (≤ 5 cm), N0, M0 * T3 (≤ 5 cm, chest wall primary tumor only), N0, M0 * No T2-T3 primary tumors \> 5 cm or any T1-T3 tumor of the mainstem bronchus involvement * No T1-T3 tumor in the lung apex (i.e., tumor in a position that will result in irradiation of the brachial plexus to the prescribed dose) * Hilar or mediastinal lymph nodes ≤ 1 cm considered N0 * Any of the following primary cancer types: * Squamous cell carcinoma * Adenocarcinoma * Large cell carcinoma * Bronchioloalveolar cell carcinoma * Non-small cell carcinoma not otherwise specified * Underlying physiological medical condition that prohibits surgery due to a low probability of tolerating general anesthesia, the operation, the postoperative recovery period, or the removal of adjacent functional lung (i.e., medically inoperable) * Cytologic specimens obtained by brushing, washing, or needle aspiration of defined lesion allowed * If sputum cytology alone is used for diagnosis, it must be confirmed on a second specimen * Must develop a radiotherapy plan that meets the dose-volume constraints for critical organs * No ataxia telangiectasia PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Not pregnant or nursing * Able and willing to complete a quality of life questionnaire unless not literate in eit…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Local tumor control rate at 2 years

Timeframe: 2 years

Trial details

NCT IDNCT00346320

SponsorNCIC Clinical Trials Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2012-02-28

View on ClinicalTrials.gov More Lung Cancer trials