Spray Cryotherapy for Esophageal Cancer (ICE-CANCER)

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.

Sex

All

Minimum age

18 Years

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

• BACKGROUNDGreenwald BD, Dumot JA, Abrams JA, Lightdale CJ, David DS, Nishioka NS, Yachimski P, Johnston MH, Shaheen NJ, Zfass AM, Smith JO, Gill KR, Burdick JS, Mallat D, Wolfsen HC. Endoscopic spray cryotherapy for esophageal cancer: safety and efficacy. Gastrointest Endosc. 2010 Apr;71(4):686-93. doi: 10.1016/j.gie.2010.01.042. PMID 20363410
• BACKGROUNDGreenwald BD, et al. Spray cryotherapy for esophageal cancer: Long-term results. Am J Gastroenterol 2011;106:S7
• BACKGROUNDGreenwald BD, Dumot JA, Horwhat JD, Lightdale CJ, Abrams JA. Safety, tolerability, and efficacy of endoscopic low-pressure liquid nitrogen spray cryotherapy in the esophagus. Dis Esophagus. 2010 Jan;23(1):13-9. doi: 10.1111/j.1442-2050.2009.00991.x. Epub 2009 Jun 9. PMID 19515183
• BACKGROUNDRibeiro 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/
• BACKGROUNDGage AA, Baust J. Mechanisms of tissue injury in cryosurgery. Cryobiology. 1998 Nov;37(3):171-86. doi: 10.1006/cryo.1998.2115. PMID 9787063
• BACKGROUNDJohnston LR, Johnston MH. Cryo Spray Ablation (CSA) in the Esophagus: Optimization of Dosimetry. Am J Gastroenterol 2006;101:S532-533
• BACKGROUNDDas A, Singh V, Fleischer DE, Sharma VK. A comparison of endoscopic treatment and surgery in early esophageal cancer: an analysis of surveillance epidemiology and end results data. Am J Gastroenterol. 2008 Jun;103(6):1340-5. doi: 10.1111/j.1572-0241.2008.01889.x. Epub 2008 May 28. PMID 18510606
• BACKGROUNDEll C, May A, Pech O, Gossner L, Guenter E, Behrens A, Nachbar L, Huijsmans J, Vieth M, Stolte M. Curative endoscopic resection of early esophageal adenocarcinomas (Barrett's cancer). Gastrointest Endosc. 2007 Jan;65(1):3-10. doi: 10.1016/j.gie.2006.04.033.