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Topical Mitomycin C for the Treatment of Complex Benign Esophageal Anastomotic Strictures, GI-108 Study

Trial Status: Temporarily Closed to Accrual

This phase II trial investigates how well mitomycin C works for the treatment of a condition called complex benign esophageal anastomotic stricture, in which the food pipe becomes narrow due to non-cancerous reasons and there is difficulty in swallowing (dysphagia). Endoscopic dilation is carried out without using mitomycin C as a standard care but the use of this drug may reduce the number of procedures needed to achieve dilation and to reduce dysphagia. Mitomycin C may also prevent recurrence of stricture.

Inclusion Criteria

  • Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent document
  • Patients must have symptomatic (dysphagia >= 2), treatment naïve complex esophageal anastomotic stricture (length > 2 cm or diameter =< 9mm) or a recurrent or refractory stricture following maximal 1-3 endoscopic dilations
  • Esophago-gastro or esophago-jejunal anastomosis with or without having undergone neoadjuvant or adjuvant radio-chemotherapy
  • Any patient taking antiplatelet agents such as Plavix, Effient, Brilinta, Aggrenox must be able to hold the drugs 5 days prior to dilation and may resume 3 days after the dilation
  • Any patient on vitamin K antagonists such as warfarin must be able to hold the drugs 5 days prior to dilation and may resume 3 days after the dilation. International normalized ratio (INR) should be checked for such patients at least 24 hours before dilation and it must be < 1.5
  • Patients taking direct thrombin inhibitors such as Pradaxa, Angiomax must be able to hold the drugs 5 days prior to dilation and may resume 3 days after the dilation
  • Patients taking Factor Xa inhibitors must be able to hold the drugs 2 days prior to dilation and may resume 3 days after dilation
  • Patients taking GIIB/IIIA inhibitors must be able to hold the drugs 1 day prior to dilation and resume 3 days after the dilation
  • Patients taking unfractionated heparin must be able to hold the drug 6 hours before dilation and low molecular weight heparin must be held 24 hours before dilation. Unfractionated heparin may resume immediately after the dilation while low molecular weight heparin may resume 3 days after dilation

Exclusion Criteria

  • Patients with malignant strictures
  • Patients with non-complex benign strictures
  • Patients with anastomosis creation within =< 2 weeks
  • Patients with suspected gastrointestinal perforation or leak that could result in extraluminal extravasation of mitomycin C
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant or breast feeding
  • Patients receiving systemic chemotherapy during the treatment of esophageal stricture

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Michael Bartel
Phone: 215-728-2577

PRIMARY OBJECTIVE:

I. To compare the rate of dysphagia >= grade 1 after the dilation procedure when 15mm dilation and zero dysphagia was achieved in patients treated with mitomycin C versus (vs) normal saline until 6 months after the first follow-up.

SECONDARY OBJECTIVES:

I. Number of procedures needed to reach dilation goal of at least 15mm and zero dysphagia in control vs mitomycin C treated patients.

II. Overall adverse events in mitomycin C vs control treated patients.

III. To evaluate the reliability of dysphagia symptoms by completing Mayo Dysphagia Questionnaire-30day (MDQ-30).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo standard of care esophagogastroduodenoscopy (EGD), then receive mitomycin C topically via endoscope over 3 minutes in each quadrant. If dilation of 15 mm is not achieved and dysphagia persists, patients undergo additional EGD every 2 weeks for a maximum of 4 EGD procedures.

ARM II: Patients undergo standard of care EGD, then receive normal saline topically via endoscope over 3 minutes in each quadrant. If dilation of 15 mm is not achieved and dysphagia persists, patients undergo additional EGD every 2 weeks for a maximum of 4 EGD procedures.

After completion of study treatment, patients are followed up at 30 days, 4 weeks, and 6 months.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Fox Chase Cancer Center

Principal Investigator
Michael Bartel

  • Primary ID GI-108
  • Secondary IDs NCI-2020-05889, 18-1022
  • Clinicaltrials.gov ID NCT04037072