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

NCT00921739 | Completed Phase 1

• 1 other identifier: Pro00017361
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD) of IMRT

  within 30 days of completing RT

Secondary Outcomes (2)

• The occurrence of RT-induced acute esophagitis

  One year

• To determine if biological predictors of esophagitis can identify patients who develop severe esophageal toxicity during radiation therapy

  Two years

Study Arms (1)

IMRT concurrent with chemotherapy

EXPERIMENTAL

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

Interventions

Esophageal sparing IMRT RADIATION

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).

IMRT concurrent with chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older.
• Negative pregnancy test in women of child-bearing potential

You may not qualify if:

• Prior thoracic irradiation
• Medical contraindications to thoracic irradiation

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (4)

• 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.

  PMID: 11571735 BACKGROUND

• 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.

  PMID: 16730134 BACKGROUND

• 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.

  PMID: 12243810 BACKGROUND

• 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.

  PMID: 34114913 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Thymoma; Thymus Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Christopher Kelsey, MD

  Duke University Medical Center, Dept Radiation Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2009
• First Posted: June 16, 2009
• Study Start: September 11, 2009
• Primary Completion: December 1, 2014
• Study Completion: November 1, 2016
• Last Updated: April 2, 2020

Record last verified: 2020-03

Locations

US (1)