Phase I Trial Of IMRT Using A Contralateral Esophagus Sparing Technique (CEST) In Locally Advanced Lung Cancer

NCT02394548 | Completed Results DMC

• 1 other identifier: 15-023
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief Summary

This research study is examining the benefit of a novel radiation planning approach on the likelihood of developing severe esophagitis (irritation and inflammation of the esophagus) during the course of radiation therapy with concurrent chemotherapy which is associated with very painful and difficult swallowing.

Conditions

Non-small Cell Lung Carcinoma; Small Cell Lung Carcinoma

Keywords

Locally advanced, inoperable non-small cell lung carcinoma; Limited stage small cell lung carcinoma; Acute esophagitis; Intensity-modulated radiation therapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Grade 3 or Higher Acute Esophagitis (CTCAE)

  Esophagitis will be measured using the Common Toxicity Criteria for Adverse Effects (CTCAE) v4 scoring scale

  up to 3 months

Secondary Outcomes (4)

• Number of Participants With Grade 3 or Higher Acute Esophagitis (RTOG)

  Baseline , up to 3 Months

• Number of Participants With Adverse Events

  Baseline, up to 2 Years

• Rate of Local and Regional Failure

  Median follow-up of up to 2 years

• Overall Survival Rate

  2 Years

Study Arms (1)

Contralateral Esophagus Sparing Technique (CEST)

EXPERIMENTAL

IMRT with CEST and concurrent chemotherapy (any standard-of-care regimen)

Radiation: Contralateral Esophageal Sparing Technique (CEST)

Interventions

Contralateral Esophageal Sparing Technique (CEST) RADIATION

Determine whether CEST decreases rate of severe acute esophagitis

Contralateral Esophagus Sparing Technique (CEST)

Eligibility Criteria

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

You may qualify if:

• Participants must meet the following criteria on screening examination to be eligible to participate in the study.
• Histologically or cytologically proven diagnosis of NSCLC or SCLC
• NSCLC, patients with clinical stage IIB-IV patients (AJCC, 7th ed.) are eligible, and for SCLC, limited-stage patients are eligible, if documented to be a candidate for definitive radiation and concurrent chemotherapy in the radiation oncologist or medical oncologist clinic note.
• Stage IV NSCLC patients are eligible only if they have a solitary brain metastasis
• Patients with non-malignant pleural effusion are eligible. --- If a pleural effusion is present, the following criteria must be met to exclude malignant involvement:
• When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative.
• Exudative pleural effusions are excluded, regardless of cytology;
• Effusions that are minimal (ie, not visible on chest x-ray) that are too small to safely tap are eligible.
• Gross tumor (primary tumor or involved lymph node) must be within 1 cm of esophagus on the most recent chest CT scan.
• ECOG performance status 0-1 within 30 days prior to registration;
• Age ≥18
• Women of childbearing potential must indicate that there is not a possibility of being pregnant at the time of enrollment or have a negative serum pregnancy test prior to the initiation of radiation therapy.
• Women of childbearing potential and male participants must practice adequate contraception.
• Patient must provide study-specific informed consent prior to study entry.

You may not qualify if:

• Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
• Greater than minimal, exudative, or cytologically positive pleural effusions
• Tumor suspected or known to invade the esophagus
• Prior chemotherapy if this precludes administration of concurrent chemotherapy for protocol treatment. Note that induction chemotherapy is allowed as long as concurrent chemotherapy is possible.
• Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
• Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients.
• Any history of allergic reaction to chemotherapies used

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Newton-Wellesley Hospital

Newton, Massachusetts, 02462, United States

Location

Related Publications (1)

• Kamran SC, Yeap BY, Ulysse CA, Cronin C, Bowes CL, Durgin B, Gainor JF, Khandekar MJ, Tansky JY, Keane FK, Olsen CC, Willers H. Assessment of a Contralateral Esophagus-Sparing Technique in Locally Advanced Lung Cancer Treated With High-Dose Chemoradiation: A Phase 1 Nonrandomized Clinical Trial. JAMA Oncol. 2021 Jun 1;7(6):910-914. doi: 10.1001/jamaoncol.2021.0281.

  PMID: 33830168 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

This protocol received IRB approval on 7/20/21 to remove secondary outcome "Median Survival Time" so this pre-specified outcome was subsequently deleted from the CT.gov record. The reason is that the secondary outcome of median survival time was not reached at time of analysis and final publication.

Results Point of Contact

• Title: Dr. Henning Willers
• Organization: Massachusetts General Hospital

hwillers@mgh.harvard.edu

617-726-5184

Study Officials

• Henning Willers, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: March 20, 2015
• Study Start: June 1, 2015
• Primary Completion: February 1, 2019
• Study Completion: March 1, 2021
• Last Updated: December 9, 2021
• Results First Posted: February 24, 2020

Record last verified: 2021-12

Locations

US (2)