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Spray Cryotherapy for Esophageal Cancer (ICE-CANCER) (ICE-CANCER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01868139
Recruitment Status : Terminated (insufficient accrual)
First Posted : June 4, 2013
Results First Posted : October 17, 2019
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Bruce Greenwald, University of Maryland, College Park

Brief Summary:

The goal of this study is to evaluate the safety and efficacy of endoscopic spray cryotherapy using the CSA Medical, Inc. truFreeze System for patients with previously untreated early-stage cancer (T1a, N0, M0) who are ineligible or refuse conventional therapy including surgery, chemotherapy, radiation therapy, and endoscopic resection.

It is hypothesized that one of the two following outcomes will occur:

  1. Complete response to therapy: complete tumor eradication confirmed through histologic examination of biopsy specimens from the targeted esophageal tissue site;
  2. Stable disease: tumor remission is not attained, but disease progression is halted.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Device: Liquid nitrogen spray cryotherapy with the truFreeze device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Multi-Center Study of Interventional Spray Cryotherapy for Early-Stage Esophageal Cancer (ICE-CANCER)
Study Start Date : June 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cryotherapy
Liquid nitrogen spray cryotherapy with the truFreeze device
Device: Liquid nitrogen spray cryotherapy with the truFreeze device
Low-pressure liquid nitrogen is sprayed through an upper endoscope on the diseased esophageal tissue to freeze and destroy it. The upper endoscope enables direct visualization of mucosal freeze during spray of the liquid nitrogen onto the mucosa and avoids the need for direct contact with the tissues. The target area is frozen and thawed for several consecutive cycles. The treated tissue becomes necrotic and sloughs, with new, healthy tissue regenerating in its place.
Other Name: truFreeze




Primary Outcome Measures :
  1. Response Rate to Therapy [ Time Frame: 5 years ]

    The primary endpoint is to determine the response rate to spray cryotherapy.

    It is hypothesized that one of the two following outcomes will occur:

    1. Complete response to therapy: complete tumor eradication confirmed through histologic examination of biopsy specimens from the targeted esophageal tissue site;
    2. Stable disease: tumor remission is not attained, but disease progression is halted.


Secondary Outcome Measures :
  1. Disease-free Survival at 12 Months After Treatment [ Time Frame: 12 months ]
  2. Cancer Recurrence Rate at 12 Months After Treatment [ Time Frame: 12 months ]
  3. Estimate Overall Survival [ Time Frame: 12 months ]
  4. Estimate Progression-free Survival in Those Who do Not Achieve Complete Pathologic Response [ Time Frame: 36 months ]
  5. Number of Treatment Sessions Needed for Complete Response in Subjects in Whom the Primary Endpoint is Attained; [ Time Frame: 12 months ]
  6. Safety of Spray Cryotherapy in This Setting; [ Time Frame: 36 months ]
    Number of participants with adverse events; Number of adverse events within the study



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • T1aN0M0 esophageal cancer (tumor invades no deeper than lamina propria or muscularis mucosa, no regional lymph node or distant metastases), with the following minimum diagnostic workup:
  • History/physical exam within 6 weeks prior to enrollment
  • PET and CT scan of the chest and abdomen within 12 weeks prior to enrollment
  • Endoscopy with histology or cytology confirming carcinoma
  • Endoscopic ultrasound (EUS) with evaluation of the esophageal wall, mediastinum, and upper abdomen for evidence of abnormal lymph nodes. Suspicious lymph nodes will undergo EUS-guided fine needle aspiration if appropriate, as determined by the investigator.
  • Endoscopic resection of focal lesions with histologic confirmation of positive deep margin or residual cancer within the esophagus
  • Not a candidate for or refuses conventional therapies (surgery, radiation, chemotherapy, endoscopic resection) as determined by evaluation by the investigator, discussion with the patient, and review in Thoracic or Gastrointestinal Tumor Board.
  • For females: not pregnant (negative pregnancy test within 14 days of starting study treatment), on acceptable means of contraception (oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, intrauterine device or tubal ligation), or not of child bearing potential. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
  • 18 years of age or older
  • ECOG Performance Status 0 - 2

Exclusion Criteria:

  • Medically unfit or other contraindication to tolerate upper endoscopy with ablation
  • Contraindication to endoscopic spray cryotherapy as outlined in the directions for use for the device
  • Other malignancy (except nonmelanoma skin cancer) within the past 1 year
  • Co-morbid illness expected to cause death within 6 months
  • Esophageal stricture preventing passage of endoscope or catheter
  • Concurrent enrollment in an investigational drug or device trial that clinically interferes with this study's endpoints throughout the study
  • Inability to provide informed consent or comply with this protocol
  • Concurrent or previous cancer therapy for current esophageal malignancy by esophagectomy, chemotherapy, radiation therapy, and photodynamic therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01868139


Locations
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United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, Baltimore
Investigators
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Principal Investigator: Bruce D Greenwald, MD University of Maryland, College Park
Publications:
Greenwald BD, et al. Spray cryotherapy for esophageal cancer: Long-term results. Am J Gastroenterol 2011;106:S7
Ribeiro A, et al. First report of spray cryosurgery depth of injury to the human esophagus. 2010. http://www.sages.org/meetings/annual_meeting/2010/resources/
Johnston LR, Johnston MH. Cryo Spray Ablation (CSA) in the Esophagus: Optimization of Dosimetry. Am J Gastroenterol 2006;101:S532-533

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Responsible Party: Bruce Greenwald, Professor of Medicine, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT01868139    
Other Study ID Numbers: HP-00052885
First Posted: June 4, 2013    Key Record Dates
Results First Posted: October 17, 2019
Last Update Posted: February 25, 2020
Last Verified: September 2019
Keywords provided by Bruce Greenwald, University of Maryland, College Park:
Cryotherapy
Esophageal cancer
Esophageal carcinoma
Liquid nitrogen
Esophageal adenocarcinoma
Esophageal squamous cell carcinoma
Endoscopy
Ablation
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases