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

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00921739
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arm: 1
• Actual Duration (Months): 85.7
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer; Small Cell Lung Cancer; Thymoma; Thymus Neoplasms	Radiation: Esophageal sparing IMRT	Phase 1

Detailed Description

Prospective phase I study designed to determine the maximum tolerated dose of radiation therapy given in an accelerated fashion (2 Gy/fraction, 6 fractions/week) with concurrent chemotherapy. Intensity-modulated radiation therapy (IMRT) will be utilized to spare the esophagus. All patients on the dose escalation study will participate in additional assessments evaluating esophageal motion and esophageal toxicity from radiation therapy.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I Dose Escalation Study of Accelerated Fractionation With Esophageal Sparing Using Intensity-Modulated Radiation Therapy for Locally-Advanced Thoracic Malignancies Including a Prospective Assessment of Esophageal Motion and Radiation-Induced Esophageal Injury
• Actual Study Start Date: Sep 11, 2009
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Nov 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IMRT concurrent with chemotherapy 6 fractions of esophageal sparing IMRT weekly for 5-6 weeks (dependent on dose cohort) concurrent with standard chemotherapy: Cisplatin 50 mg/m2 /d intravenously (IV) on days 1, 8, 29, and 36. Etoposide 50 mg/m2 /d IV on days 1 through 5 and 29 through 33.	Radiation: Esophageal sparing IMRT; 6 fractions/week of 2Gy each for 29 fx (58 Gy), 31 fx (62 Gy), 33 fx (66 Gy), 35 fx (70 Gy), or 37 fx (74 Gy).

Outcome Measures

Primary Outcome Measures

1. Maximum tolerated dose (MTD) of IMRT [within 30 days of completing RT]

Secondary Outcome Measures

1. The occurrence of RT-induced acute esophagitis [One year]

2. To determine if biological predictors of esophagitis can identify patients who develop severe esophageal toxicity during radiation therapy [Two years]

   Blood will be drawn at specific time intervals, plasma will be analysed for Glutathione Oxidation, Citrulline, Lipid peroxidation, DNA oxidation, and Tetrahydrobiopterin.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27710

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Christopher Kelsey, MD, Duke University Medical Center, Dept Radiation Oncology

Study Documents (Full-Text)

None provided.

More Information

Publications

• Schild SE, McGinnis WL, Graham D, Hillman S, Fitch TR, Northfelt D, Garces YI, Shahidi H, Tschetter LK, Schaefer PL, Adjei A, Jett J. Results of a Phase I trial of concurrent chemotherapy and escalating doses of radiation for unresectable non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2006 Jul 15;65(4):1106-11. Epub 2006 May 26.
• Schild SE, Stella PJ, Geyer SM, Bonner JA, Marks RS, McGinnis WL, Goetz SP, Kuross SA, Mailliard JA, Kugler JW, Schaefer PL, Jett JR. Phase III trial comparing chemotherapy plus once-daily or twice-daily radiotherapy in Stage III non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2002 Oct 1;54(2):370-8.
• Socinski MA, Rosenman JG, Halle J, Schell MJ, Lin Y, Russo S, Rivera MP, Clark J, Limentani S, Fraser R, Mitchell W, Detterbeck FC. Dose-escalating conformal thoracic radiation therapy with induction and concurrent carboplatin/paclitaxel in unresectable stage IIIA/B nonsmall cell lung carcinoma: a modified phase I/II trial. Cancer. 2001 Sep 1;92(5):1213-23.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT00921739
• Other Study ID Numbers: Pro00017361
• First Posted: Jun 16, 2009
• Last Update Posted: Apr 2, 2020
• Last Verified: Mar 1, 2020

• Keywords provided by Duke University: Non small cell lung cancer; Small cell lung cancer; Thymoma unresectable; Thymic carcinoma unresectable
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Thymoma; Thymus Neoplasms

Study Results

No Results Posted as of Apr 2, 2020