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 range18 Years

SexALL

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

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

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