Clinical trial NCT00921739: Esophageal Sparing Intensity-modulated Radiation Therapy (IMRT) for Locally-Advanced Thoracic Malignancies
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non Small Cell Lung Cancer
Small Cell Lung Cancer
Thymoma
Thymus Neoplasms
Keywords: Non small cell lung cancer
Small cell lung cancer
Thymoma unresectable
Thymic carcinoma unresectable
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2009-06-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum tolerated dose (MTD) of IMRT
timeFrame: within 30 days of completing RT
Secondary outcomes:
measure: The occurrence of RT-induced acute esophagitis
timeFrame: One year
measure: To determine if biological predictors of esophagitis can identify patients who develop severe esophageal toxicity during radiation therapy
timeFrame: Two years
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University Medical Center, Dept Radiation Oncology
name: Christopher Kelsey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1002/1097-0142(20010901)92:53.0.co;2-0.
citation: 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. doi: 10.1016/j.ijrobp.2006.02.046. Epub 2006 May 26.
citation: 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. doi: 10.1016/s0360-3016(02)02930-9.
citation: Lafata KJ, Corradetti MN, Gao J, Jacobs CD, Weng J, Chang Y, Wang C, Hatch A, Xanthopoulos E, Jones G, Kelsey CR, Yin FF. Radiogenomic Analysis of Locally Advanced Lung Cancer Based on CT Imaging and Intratreatment Changes in Cell-Free DNA. Radiol Imaging Cancer. 2021 Apr;3(4):e200157. doi: 10.1148/rycan.2021200157.