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Preoperative Ultra-hypofractionated Radiotherapy Followed by Surgery for Retroperitoneal Sarcoma

Primary Purpose

Soft Tissue Sarcoma, Retroperitoneal Sarcoma, Radiotherapy Side Effect

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
ultra-hypofractionated radiotherapy
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Soft Tissue Sarcoma focused on measuring stereotactic ablative radiotherapy, hypofractionated radiotherapy, retroperitoneal sarcoma, soft tissue sarcoma, peri-operative complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary soft tissue sarcoma of retroperitoneal or infra-peritoneal spaces of pelvis
  • Sarcoma not originated from bone structure, abdominal or gynecological viscera
  • All disease can be included safely within one radiotherapy field
  • Absence of extension through the sciatic notch or across the diaphragm
  • Histologically proven, excluding the following subtypes: Gastro-intestinal stromal tumors (GIST), rhabdomyosarcoma, PNET or other small round blue cells sarcoma, osteosarcoma or chondrosarcoma, aggressive fibromatosis, sarcomatoid or metastatic carcinoma
  • ECOG performance status 0 to 2
  • American Society of Anesthesiologist (ASA) score ≤2
  • Normal renal function: Calculated Creatinine Clearance ≥50ml/min（by Cockcroft-Gault formula）and functional contralateral kidney by differential renal isotope scan
  • Normal bone marrow and hepatic function.
  • Contraception was needed for female patients of child-bearing age, or male patients whose partner had child-bearing age
  • expected life expectancy longer than 5 years
  • Written consent form was given prior to treatment
  • Can safely be treated by radiotherapy and surgery

Exclusion Criteria:

  • metastatic disease
  • Tumor was previously treated by radiotherapy
  • Involvement of liver, pancreatic head or duodenum

Sites / Locations

  • Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ultra-hypofractionated radiotherapy

Arm Description

Patients receive ultra-hypo-fractionated radiotherapy with 25Gy to 50Gy in five fractions, followed by surgery done at 1 to 2 months post-RT

Outcomes

Primary Outcome Measures

Peri-operative complications
The proportion of patients who suffer from

Secondary Outcome Measures

Full Information

First Posted
January 25, 2022
Last Updated
January 25, 2022
Sponsor
Chinese Academy of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05224934
Brief Title
Preoperative Ultra-hypofractionated Radiotherapy Followed by Surgery for Retroperitoneal Sarcoma
Official Title
Preoperative Ultra-hypofractionated Radiotherapy Followed by Surgery for Primary and Relapsed Retroperitoneal Sarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To investigate the feasibility and peri-operative complications of preoperative hypo-fractionated radiotherapy followed by surgery for retroperitoneal sarcoma

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma, Retroperitoneal Sarcoma, Radiotherapy Side Effect, Ultra-hypofractionated Radiotherapy, Stereotactic Ablative Radiotherapy
Keywords
stereotactic ablative radiotherapy, hypofractionated radiotherapy, retroperitoneal sarcoma, soft tissue sarcoma, peri-operative complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultra-hypofractionated radiotherapy
Arm Type
Experimental
Arm Description
Patients receive ultra-hypo-fractionated radiotherapy with 25Gy to 50Gy in five fractions, followed by surgery done at 1 to 2 months post-RT
Intervention Type
Radiation
Intervention Name(s)
ultra-hypofractionated radiotherapy
Intervention Description
stereotactic ablative radiotherapy with 25 to 50Gy in five fractions given preoperatively
Primary Outcome Measure Information:
Title
Peri-operative complications
Description
The proportion of patients who suffer from
Time Frame
From surgery date up to 7 days later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary soft tissue sarcoma of retroperitoneal or infra-peritoneal spaces of pelvis Sarcoma not originated from bone structure, abdominal or gynecological viscera All disease can be included safely within one radiotherapy field Absence of extension through the sciatic notch or across the diaphragm Histologically proven, excluding the following subtypes: Gastro-intestinal stromal tumors (GIST), rhabdomyosarcoma, PNET or other small round blue cells sarcoma, osteosarcoma or chondrosarcoma, aggressive fibromatosis, sarcomatoid or metastatic carcinoma ECOG performance status 0 to 2 American Society of Anesthesiologist (ASA) score ≤2 Normal renal function: Calculated Creatinine Clearance ≥50ml/min（by Cockcroft-Gault formula）and functional contralateral kidney by differential renal isotope scan Normal bone marrow and hepatic function. Contraception was needed for female patients of child-bearing age, or male patients whose partner had child-bearing age expected life expectancy longer than 5 years Written consent form was given prior to treatment Can safely be treated by radiotherapy and surgery Exclusion Criteria: metastatic disease Tumor was previously treated by radiotherapy Involvement of liver, pancreatic head or duodenum
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ning-Ning Lu
Phone
+868611804268
Email
Ning-Ning.Lu@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shu-Lian Wang
Email
wsl20040118@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ning-Ning Lu
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ningning Lu, Doctor
Phone
+86 01087787630
Email
Ning-Ning.Lu@hotmail.com
First Name & Middle Initial & Last Name & Degree
Shu-Lian Wang, M.D.
Phone
+86 01087788280
Email
wsl20040118@yahoo.com
First Name & Middle Initial & Last Name & Degree
Nian-Zeng Xing, M.D
First Name & Middle Initial & Last Name & Degree
Shu-Lian Wang, M.D
First Name & Middle Initial & Last Name & Degree
Ning-Ning Lu, M.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Preoperative Ultra-hypofractionated Radiotherapy Followed by Surgery for Retroperitoneal Sarcoma

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