Active — Not RecruitingPhase 1

Radiation Dose Intensification With Accelerated Hypofractionated Intensity Modulated Radiation Therapy and Concurrent Carboplatin and Paclitaxel for Inoperable Esophageal Cancer

United States12 participantsStarted 2019-11-07

Plain-language summary

Rates of local disease control in patients with locally advanced esophageal cancer who are not candidates for surgical resection are suboptimal. Despite treatment with chemotherapy and radiation therapy approximately half of patients will develop recurrence of their cancer at the site of the original primary cancer. Salvage therapy options are largely ineffective and nearly all patients who develop local disease recurrence will succumb to their cancer. Recent clinical trials for lung cancer have demonstrated that local tumor control can be improved safely with accelerated hypofractionated radiation therapy regimens in order to achieve radiation dose intensification. This clinical trial aims to adapt those techniques and assess the safety of such a regimen for the treatment of inoperable thoracic esophageal cancers.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Biopsy-proven carcinoma of the thoracic esophagus, or gastroesophageal junction (GEJ). * Amenable to definitive chemoradiation. * Unresectable esophageal cancer or not a surgical candidate as determined by a surgeon or multidisciplinary tumor board. * At least 18 years of age. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Complete blood count (CBC) with differential obtained within 30 days prior to registration with adequate bone marrow function: * Absolute neutrophil count (ANC) ≥1,500 cells/mm3 * Platelets ≥100,000 cells/ mm3 * Hemoglobin ≥9 g/dL (transfusion or other intervention to achieve hemoglobin ≥9 g/dL is acceptable). * Adequate renal function within 30 days prior to registration: Serum creatinine ≤ 1.5x upper limit of normal or calculated creatinine clearance ≥ 50 mL/min within 30 days prior to registration estimated by the Cockcroft-Gault formula: Creatinine Clearance (male) = \[(140 - age) x (wt in kg)\] \[(Serum Creatinine mg/dl) x (72)\] Creatinine Clearance (female) = 0.85 x Creatinine Clearance (male) \*Adequate hepatic function within 30 days prior to registration: bilirubin ≤ 1.5x upper limit of normal, ALT/AST ≤3 x upper limit of normal (ULN). * Negative pregnancy test within 14 days of registration or otherwise be determined to not be of childbearing potential. Postmenopausal women must be amenorrheic for 12 months or more. Women of childbearing potential must agree to perform appropriate contracepti…

What they're measuring

Maximum tolerated dose (MTD) of hypofractionated IMRT with chemotherapy

Timeframe: Through 6 month follow-up for all enrolled patients (estimated to be 65 months)

Trial details

NCT IDNCT04046575

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-02