Status:
TERMINATED
Spray Cryotherapy for Esophageal Cancer (ICE-CANCER)
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 (T1...
Detailed Description
Background Endoscopic modalities have been reported to be effective in definitive treatment of early stage esophageal cancer. A study comparing endoscopic treatment to surgery in early esophageal can...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01868139
Start Date
June 1 2013
End Date
December 1 2014
Last Update
March 7 2022
Active Locations (1)
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1
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201