CompletedPhase 1

Esophageal Sparing Intensity-modulated Radiation Therapy (IMRT) for Locally-Advanced Thoracic Malignancies

United States24 participantsStarted 2009-09-11

Plain-language summary

Hypothesis 1- Using IMRT, the radiation therapy (RT) dose can be safely escalated from 58 Gy to 74 Gy given as 6 fractions/week with concurrent chemotherapy. Hypothesis 2- Esophageal motion can be used to customize planning organ at risk volumes. Hypothesis 3- Biological predictors of acute esophagitis can be used to identify patients at high risk of developing esophageal toxicity from radiation therapy and chemotherapy.

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.

Inclusion Criteria: * Histologic documentation of one of the following thoracic malignancies: * Non-small cell lung cancer (stage III or X (recurrent) with disease confined to local/regional sites) * Small cell lung cancer (stage II-III) * Thymoma (unresectable) * Thymic carcinoma (unresectable) * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Weight loss \< 10% in preceding 3 months prior to diagnosis * ANC \> or = 1500 and platelet count \> or = 100,000. * Creatinine clearance greater than 50 ml/min * 18 years of age or older. * Negative pregnancy test in women of child-bearing potential Exclusion Criteria: * Prior thoracic irradiation * Medical contraindications to thoracic irradiation

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

Maximum tolerated dose (MTD) of IMRT

Timeframe: within 30 days of completing RT

Trial details

NCT IDNCT00921739

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-12

View on ClinicalTrials.gov More Non Small Cell Lung Cancer trials