esophageal cancer
Conditions
Interventions
investigational material(s)
Generic name etc : Cryosurgical unit
INN of investigational material :
Therapeutic category code :
Dosage and Administration for Investigational material : The lesions ar
Sponsors
National Cancer Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligibility criteria include, but are not limited to, the following: 1) Patients from whom written consent to participate in the study is obtained. 2) Patients aged greater than 20 years at the time of consent obtaining. 3) Patients with esophageal cancer who have been histologically diagnosed with squamous cell carcinoma. 4)Patients whose lesions are diagnosed on or near the scar after endoscopy treatment, whose lesions depth is within the mucosa, and for whose lesions ESD/EMR is technically difficult. 5) Patients having a lesion within thoracic or abdominal esophagus 6) Patients showing neither lymph node metastasis nor distant metastasis in image by CT at screening. 7) Patients who can pass through a therapeutic endoscope. 8) Patients with an ECOG Performance Status (PS) of 0 to 2 at the time of enrollment. 9) Patients who are judged to have enough organ functions based on laboratory values measured within 28 days before enrollment. 10) Patients who can follow up 12 months after primary cryoablation. 11) Women of childbearing potential who are negative in a urine pregnancy test agree to use contraception from obtaining informed consent through 6 months after the Cryoablation.
Exclusion criteria
Exclusion criteria: Exclusion criteria including below but not limited to: 1) Diameter of lesion >50mm 2) Circumferential extent of target lesion is 360 degrees. 3) Patients whom a lesion targeted for treatment has more than 4 lesions 4) Patients whose Cryoablation treatment area is expected to cover the entire circumference. 5) Patients who has active multiple primary cancer. 6) Target tissue varices at risk for bleeding 7) Prior Heller myotomy 8) Patients who has serious complications such as Unstable angina, uncontrolled blood pressure, serious heart disease. 9) Patients with respiratory disease requiring oxygen administration. 10) Patients having serious complications 11) Pregnant or breastfeeding female patients. 12) Patients who are judged by the principal investigator as ineligible to be administered the Cryoablation, or in whom the principal investigator judges that treatment cannot be performed safely.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Rate of local complete response (L-CR) judged in an independent committee after 48 weeks from the Cryoablation. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy safety other 1) Rate of local complete response (L-CR) judged the principal investigator or sub-investigator after 48 weeks from the Cryoablation. 2) Rate of L-CR for all lesions 3) Rate of technically successful ablation 4) Treatment time of the Cryoablation 5) Pain score after the treatment 6) Recurrence free survival 7) Overall survival 8) Incidence rate of adverse event | — |
Countries
Japan
Outcome results
None listed