Clinical Trials/NCT05844813

NCT05844813

Enrolling by Invitation

Phase 4

Neoadjuvant Chemotherapy Combined With Targeted Treatment in High-risk Retroperitoneal Sarcoma-- A Nationwide Multicentered Prospective Controlled Study

Peking University International Hospital6 sites in 1 country102 target enrollmentNovember 1, 2022

ConditionsRetroperitoneal Sarcoma

InterventionsDoxorubicin+Ifosfamide+Anlotinib(AI+A)Radical Surgery

DrugsDoxorubicin+Ifosfamide+Anlotinib(AI+A)

Overview

Phase: Phase 4
Intervention: Doxorubicin+Ifosfamide+Anlotinib(AI+A)
Conditions: Retroperitoneal Sarcoma
Sponsor: Peking University International Hospital
Enrollment: 102
Locations: 6
Primary Endpoint: 3-year Progression Free Survival(PFS)
Status: Enrolling by Invitation
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 1, 2022

End Date

November 1, 2027

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Peking University International Hospital

Responsible Party

Principal Investigator

Jun Chen

Peking University International Hospital

Eligibility Criteria

Inclusion Criteria

•Histologically proven primary high-risk Retroperitoneal sarcoma(RPS) (Including Dedifferentiated liposarcoma (DDLPS), leiomyosarcoma(LMS), Undifferentiated pleomorphic sarcoma(UPS), Solitary fibrous tumor(SFT)).
•Primary localized RPS without histories of surgical resection, chemo- or radio-therapy, targeted therapy. Patients who underwent laparotomy with biopsy only will also be considered as primary cases.
•Without histories of second malignant tumors.
•Diagnosis should be confirmed based on MDM2(Mouse double minute 2 homolog) and CDK4(Cyclin-dependent kinase 4) expression on IHC (immunohistochemistry), while MDM2 amplification in the Fish test is highly recommended.
•All grade 2-3 DDLPS can be included.
•All grades of LMS can be included.
•Tumor size ≥10cm
•In UPS or SFT
•All grades of UPS can be included.
•High-risk SFT with a score ≥6 in 'Risk stratification of SFT for development of metastasis' introduced in The 5th edition of the WHO(World Health Organization) Soft tissue sarcoma classification.

Exclusion Criteria

•Sarcoma confirmed originating from the GI tract, uterus, or urinal tract.
•Patients included in the study through preoperative biopsy or MDT discussion, with WDLPS, grade 1 LPS, or other types of tumors not mentioned in the Inclusion criteria evaluating through final pathological findings.
•Sarcoma protruded into the chest cavity evaluated through preoperative imaging or surgical reports.
•Metastasis confirmed pathologically or highly suspicious metastatic lesions through radiological findings, PET-CT(Positron emission tomography) is highly recommended, MDT discussion and evaluation are needed.
•Histories of administration of Anthracyclines, Ifosfamide, and targeted agents.
•Severe contradiction to surgery and chemotherapies, including persistent myelosuppression, myocardial/cerebral/pulmonary infarction, uncontrolled cardiac arrhythmia, etc within the last 6 months
•Indication of severe infection or undergoing surgeries with high-risk hemorrhages in one month.
•Persistent one or more organ or system dysfunctions, could not be recovered prior to the study.
•Female patients who are pregnant or breastfeeding or female and male patients of reproductive potential who are not willing to employ effective birth control methods.
•Patients with psychological conditions

Arms & Interventions

The Neoadjuvant Therapy Group

Neoadjuvant chemotherapy + Target therapy+ Radical resectional Surgery Drugs: Doxorubicin（PLD） 40mg/㎡ d1, Ifosfamide 1g/㎡ d1-5, Anlotinib10mg d1-14 Q3weeks \* 3 Circles, Watch-Wait 4-6 weeks

Intervention: Doxorubicin+Ifosfamide+Anlotinib(AI+A)

The Neoadjuvant Therapy Group

Neoadjuvant chemotherapy + Target therapy+ Radical resectional Surgery Drugs: Doxorubicin（PLD） 40mg/㎡ d1, Ifosfamide 1g/㎡ d1-5, Anlotinib10mg d1-14 Q3weeks \* 3 Circles, Watch-Wait 4-6 weeks

Intervention: Radical Surgery

The Surgery only Group

Procedure: Radical resectional surgery

Intervention: Radical Surgery

Outcomes

Primary Outcomes

3-year Progression Free Survival(PFS)

Time Frame: 3 years after first patient enrolled in

Progression free survival will be measured from the date of surgery to the date of progression or death, whichever occurs first.

Secondary Outcomes

1-year PFS(1year after first patient enrolled in.)
5-year OS(5 years after first patient enrolled in)
Safety and toxicity of neoadjuvant therapy(1-d, 7-d after the first date of each neoadjuvant therapy session.)
Postoperative morbidities(30-d, 90-d, 1-year separately after the date of surgery.)
5-year PFS(5 years after first patient enrolled in.)
1 year Overall survival(OS)(1year after first patient enrolled in)
3-year OS(3 years after first patient enrolled in)