Preoperative Ultra-hypofractionated Radiotherapy Followed by Surgery for Retroperitoneal Sarcoma

• Sponsor: Chinese Academy of Medical Sciences (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05224934
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Soft Tissue Sarcoma; Retroperitoneal Sarcoma; Radiotherapy Side Effect; Ultra-hypofractionated Radiotherapy; Stereotactic Ablative Radiotherapy	Radiation: ultra-hypofractionated radiotherapy	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 28 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Preoperative Ultra-hypofractionated Radiotherapy Followed by Surgery for Primary and Relapsed Retroperitoneal Sarcoma
• Actual Study Start Date: Jan 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ultra-hypofractionated radiotherapy Patients receive ultra-hypo-fractionated radiotherapy with 25Gy to 50Gy in five fractions, followed by surgery done at 1 to 2 months post-RT	Radiation: ultra-hypofractionated radiotherapy; stereotactic ablative radiotherapy with 25 to 50Gy in five fractions given preoperatively

Outcome Measures

Primary Outcome Measures

1. Peri-operative complications [From surgery date up to 7 days later]

   The proportion of patients who suffer from

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radiotherapy Department of Cancer Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing	China	100021

Sponsors and Collaborators

• Chinese Academy of Medical Sciences

Investigators

• Principal Investigator: Ning-Ning Lu, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ning-Ning Lu, Principle Investigator, Chinese Academy of Medical Sciences
• ClinicalTrials.gov Identifier: NCT05224934
• Other Study ID Numbers: NCC-007744
• First Posted: Feb 4, 2022
• Last Update Posted: Feb 4, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ning-Ning Lu, Principle Investigator, Chinese Academy of Medical Sciences: stereotactic ablative radiotherapy; hypofractionated radiotherapy; retroperitoneal sarcoma; soft tissue sarcoma; peri-operative complications
• Additional relevant MeSH terms: Sarcoma

Study Results

No Results Posted as of Feb 4, 2022