Cryoablation for Advanced Bone and Soft Tissue Tumors

Sponsor

Henan Cancer Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05615545

Collaborator

(none)

Enrollment

Location

11.7

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single-center, open, retrospective clinical study of patients with metastatic/surgically unresectable bone and soft tissue sarcoma undergoing cryoablation of selected tumor lesions. All eligible patients were enrolled. Basic data and treatment methods of these patients were collected, and efficacy and safety were evaluated.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma Cryoablation	Procedure: Cryoablation

Detailed Description

This is a single-center, open, retrospective clinical study of patients with metastatic/surgically unresectable bone and soft tissue sarcoma undergoing cryoablation of selected tumor lesions. Clinical data of eligible patients were scheduled to be retrospectively collected from December 2016 to February 28, 2022. All patients eligible for inclusion. Basic data and treatment methods of these patients were collected, and efficacy and safety were evaluated.

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

Safety and Efficacy of Cryoablation in the Treatment of Advanced Bone and Soft Tissue Tumors: a Single-center Retrospective Study

Actual Study Start Date :

Mar 10, 2022

Anticipated Primary Completion Date :

Feb 28, 2023

Anticipated Study Completion Date :

Feb 28, 2023

Arms and Interventions

Arm	Intervention/Treatment
Cryoablation Cryoablation of selected tumor lesions	Procedure: Cryoablation Cryoablation of selected tumor lesions

Arm

Intervention/Treatment

Cryoablation

Cryoablation of selected tumor lesions

Procedure: Cryoablation

Cryoablation of selected tumor lesions

Outcome Measures

Primary Outcome Measures

Survival rates [12 months after surgery]
1-year survival rate
There was no local recurrence survival rate [12 months after surgery]
The 1-year survival rate without local recurrence

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

No age restriction, male or female.

The pathological diagnosis was a subtype of bone and soft tissue sarcoma.

The clinical stage was determined to be metastatic or locally unresectable bone and soft tissue sarcoma.

At least one cryoablation of tumor lesions was performed in our hospital.

Target lesions can be evaluated according to the efficacy evaluation criteria for solid tumors (RECIST; Version 1.1) Measure diameter changes.

Follow-up data were complete.

Exclusion Criteria:

Not applicable.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Bone and Soft Tissue ,Henan Cancer Hospital	Zhengzhou	Henan	China	450008

Sponsors and Collaborators

Henan Cancer Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wang Jiaqiang, associate chief physician, Henan Cancer Hospital

ClinicalTrials.gov Identifier:

NCT05615545

Other Study ID Numbers:

ZZUSC-10

First Posted:

Nov 14, 2022

Last Update Posted:

Nov 15, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Soft Tissue Neoplasms

Study Results

No Results Posted as of Nov 15, 2022