Spray Cryotherapy for Esophageal Cancer (ICE-CANCER)

NCT01868139 | Terminated Results DMC

• 1 other identifier: HP-00052885
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Conditions

Esophageal Cancer

Keywords

Cryotherapy; Esophageal cancer; Esophageal carcinoma; Liquid nitrogen; Esophageal adenocarcinoma; Esophageal squamous cell carcinoma; Endoscopy; Ablation

Outcome Measures

Primary Outcomes (1)

• Response Rate to Therapy

  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.

  5 years

Secondary Outcomes (6)

• Disease-free Survival at 12 Months After Treatment

  12 months

• Cancer Recurrence Rate at 12 Months After Treatment

  12 months

• Estimate Overall Survival

  12 months

• Estimate Progression-free Survival in Those Who do Not Achieve Complete Pathologic Response

  36 months

• Number of Treatment Sessions Needed for Complete Response in Subjects in Whom the Primary Endpoint is Attained;

  12 months

Study Arms (1)

Cryotherapy

EXPERIMENTAL

Liquid nitrogen spray cryotherapy with the truFreeze device

Device: Liquid nitrogen spray cryotherapy with the truFreeze device

Interventions

Liquid nitrogen spray cryotherapy with the truFreeze device 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.

Also known as: truFreeze

Cryotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years of age or older
• ECOG Performance Status 0 - 2

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Related Publications (13)

• Greenwald 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 BACKGROUND

• Greenwald BD, et al. Spray cryotherapy for esophageal cancer: Long-term results. Am J Gastroenterol 2011;106:S7

  BACKGROUND

• Greenwald 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 BACKGROUND

• 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/

  BACKGROUND

• Gage AA, Baust J. Mechanisms of tissue injury in cryosurgery. Cryobiology. 1998 Nov;37(3):171-86. doi: 10.1006/cryo.1998.2115.

  PMID: 9787063 BACKGROUND

• Johnston LR, Johnston MH. Cryo Spray Ablation (CSA) in the Esophagus: Optimization of Dosimetry. Am J Gastroenterol 2006;101:S532-533

  BACKGROUND

• Das 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 BACKGROUND

• Ell 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.

  PMID: 17185072 BACKGROUND

• Ell C, May A, Gossner L, Pech O, Gunter E, Mayer G, Henrich R, Vieth M, Muller H, Seitz G, Stolte M. Endoscopic mucosal resection of early cancer and high-grade dysplasia in Barrett's esophagus. Gastroenterology. 2000 Apr;118(4):670-7. doi: 10.1016/s0016-5085(00)70136-3.

  PMID: 10734018 BACKGROUND

• Overholt BF, Lightdale CJ, Wang KK, Canto MI, Burdick S, Haggitt RC, Bronner MP, Taylor SL, Grace MG, Depot M; International Photodynamic Group for High-Grade Dysplasia in Barrett's Esophagus. Photodynamic therapy with porfimer sodium for ablation of high-grade dysplasia in Barrett's esophagus: international, partially blinded, randomized phase III trial. Gastrointest Endosc. 2005 Oct;62(4):488-98. doi: 10.1016/j.gie.2005.06.047.

  PMID: 16185958 BACKGROUND

• Overholt BF, Wang KK, Burdick JS, Lightdale CJ, Kimmey M, Nava HR, Sivak MV Jr, Nishioka N, Barr H, Marcon N, Pedrosa M, Bronner MP, Grace M, Depot M; International Photodynamic Group for High-Grade Dysplasia in Barrett's Esophagus. Five-year efficacy and safety of photodynamic therapy with Photofrin in Barrett's high-grade dysplasia. Gastrointest Endosc. 2007 Sep;66(3):460-8. doi: 10.1016/j.gie.2006.12.037. Epub 2007 Jul 23.

  PMID: 17643436 BACKGROUND

• Pech O, Behrens A, May A, Nachbar L, Gossner L, Rabenstein T, Manner H, Guenter E, Huijsmans J, Vieth M, Stolte M, Ell C. Long-term results and risk factor analysis for recurrence after curative endoscopic therapy in 349 patients with high-grade intraepithelial neoplasia and mucosal adenocarcinoma in Barrett's oesophagus. Gut. 2008 Sep;57(9):1200-6. doi: 10.1136/gut.2007.142539. Epub 2008 May 6.

  PMID: 18460553 BACKGROUND

• Prasad GA, Wu TT, Wigle DA, Buttar NS, Wongkeesong LM, Dunagan KT, Lutzke LS, Borkenhagen LS, Wang KK. Endoscopic and surgical treatment of mucosal (T1a) esophageal adenocarcinoma in Barrett's esophagus. Gastroenterology. 2009 Sep;137(3):815-23. doi: 10.1053/j.gastro.2009.05.059. Epub 2009 Jun 12.

  PMID: 19524578 BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms; Adenocarcinoma Of Esophagus; Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Results Point of Contact

• Title: Dr. Bruce Greenwald
• Organization: University of Maryland School of Medicine

bgreenwa@medicine.umaryland.edu

4103288731

Study Officials

• Bruce D Greenwald, MD

  University of Maryland

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: March 30, 2013
• First Posted: June 4, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 7, 2022
• Results First Posted: October 17, 2019

Record last verified: 2022-03

Locations

US (1)