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Neoadjuvant Chemotherapy Combined With Targeted Treatment in High-risk Retroperitoneal Sarcoma

NCT05844813 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2023-05-12

No results posted yet for this study

Summary

The goal of this clinical trial is to explore the potential survival benefits of neoadjuvant chemotherapy combined with target treatments followed by radical surgery in patients with primary high-risk/grade retroperitoneal sarcoma.

The main questions it aims to answer are:

* Whether the 1,3-year progression-free survival time(PFS) is prolonged in the neoadjuvant therapy group, compared with the surgery-only group.
* The Overall survival time in the two groups.
* The safety and tolerance in the neoadjuvant therapy group.

Participants will be allocated into two groups once they meet the inclusion criteria.

* Surgery-only Group: Patients will directly undergo surgeries after the confirmation of diagnosis through pre-operative biopsy.
* Neoadjuvant therapy group: Patients will receive the neoadjuvant chemotherapy combined with target treatment for three circles before the following sarcoma resectional surgeries.

Conditions

  • Retroperitoneal Sarcoma

Interventions

DRUG

Doxorubicin+Ifosfamide+Anlotinib(AI+A)

Doxorubicin（PLD） 40mg/㎡ d1, Ifosfamide（I） 1g/㎡ d1-5, Anlotinib（A）10mg d1-14 Q3weeks \* 3 Circles

PROCEDURE

Radical Surgery

Radical sarcoma resectional surgery

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    collaborator OTHER

  • The Affiliated Hospital of Qingdao University

    collaborator OTHER

  • Peking University First Hospital

    collaborator OTHER

  • Shanghai Cancer Hospital, China

    collaborator OTHER

  • First Affiliated Hospital Xi'an Jiaotong University

    collaborator OTHER

  • Beijing Friendship Hospital

    collaborator OTHER

  • Peking University International Hospital

    lead OTHER

Principal Investigators

  • Chenghua Luo, MD, PhD · Peking University International Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2025-11-01
Completion
2027-11-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05844813 on ClinicalTrials.gov