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

Last updated: December 8, 2021
Sponsor: Massachusetts General Hospital
Overall Status: Completed

Phase

N/A

Condition

Non-small Cell Lung Cancer

Carcinoma

Small Cell Lung Cancer

Treatment

N/A

Clinical Study ID

NCT02394548
15-023
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: Participants must meet the following criteria on screening examination to be eligible toparticipate 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, andfor SCLC, limited-stage patients are eligible, if documented to be a candidate fordefinitive radiation and concurrent chemotherapy in the radiation oncologist ormedical oncologist clinic note.
  • Stage IV NSCLC patients are eligible only if they have a solitary brainmetastasis
  • Patients with non-malignant pleural effusion are eligible. --- If a pleuraleffusion is present, the following criteria must be met to exclude malignantinvolvement:
  • When pleural fluid is visible on both the CT scan and on a chest x-ray, apleuracentesis is required to confirm that the pleural fluid iscytologically negative.
  • Exudative pleural effusions are excluded, regardless of cytology;
  • Effusions that are minimal (ie, not visible on chest x-ray) that are toosmall to safely tap are eligible.
  • Gross tumor (primary tumor or involved lymph node) must be within 1 cm of esophagus onthe 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 beingpregnant at the time of enrollment or have a negative serum pregnancy test prior tothe initiation of radiation therapy.
  • Women of childbearing potential and male participants must practice adequatecontraception.
  • Patient must provide study-specific informed consent prior to study entry.

Exclusion

Exclusion Criteria: Participants who exhibit any of the following conditions at screening will not be eligiblefor 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 forprotocol treatment. Note that induction chemotherapy is allowed as long as concurrentchemotherapy is possible.
  • Prior radiotherapy to the region of the study cancer that would result in overlap ofradiation 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 toexclude patients with AIDS from this protocol is necessary because the treatmentsinvolved in this protocol may be significantly immunosuppressive. Protocol-specificrequirements may also exclude immuno-compromised patients.
  • Pregnancy or women of childbearing potential and men who are sexually active and notwilling/able to use medically acceptable forms of contraception; this exclusion isnecessary because the treatment involved in this study may be significantlyteratogenic.
  • Any history of allergic reaction to chemotherapies used

Study Design

Total Participants: 27
Study Start date:
June 01, 2015
Estimated Completion Date:
March 31, 2021

Study Description

This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied.

The U.S. Food and Drug Administration (FDA) has approved radiation with chemotherapy as a treatment option for your disease.

Currently, there are no established rules to avoid esophagitis in the treatment of lung cancer with radiation therapy. We have developed an IMRT-based technique, termed CEST, to reduce the radiation dose to the part of the esophagus that is located opposite to the tumor. The reason behind this approach is that a lower radiation dose causes less esophagus inflammation and irritation and, therefore, may preserve the swallowing function of the esophagus better. In our clinical experience, reducing the radiation dose to part of the esophagus in this fashion has shown the potential to dramatically decrease the likelihood of severe esophagitis in many though not all people with lung cancer. We therefore wish to analyze this technique further.

There is no firm data to indicate that different chemotherapy regimens given at the same time of radiation therapy result in different rates of esophagitis. The Investigators will, therefore, allow any type of standard-of-care chemotherapy regimen at the discretion of the patient's medical oncologist.

Connect with a study center

  • Massachusetts General Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Newton-Wellesley Hospital

    Newton, Massachusetts 02462
    United States

    Site Not Available

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