Trial Title:
Neoadjuvant Chemotherapy Combined With Targeted Treatment in High-risk Retroperitoneal Sarcoma
NCT ID:
NCT05844813
Condition:
Retroperitoneal Sarcoma
Conditions: Official terms:
Sarcoma
Doxorubicin
Ifosfamide
Conditions: Keywords:
Retroperitoneal Sarcoma
Neoadjuvant therapy
Target therapy
Survival
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Enrolling by invitation
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
It is a prospective non-randomized controlled study. After meeting the inclusion and
exclusion criteria, patients will be allocated either into the Surgery-only Group or the
Neoadjuvant therapy group. Patients in the surgery-only group will directly undergo
surgeries after the confirmation of diagnosis through pre-operative biopsy, while in the
neoadjuvant therapy group, patients will receive neoadjuvant chemotherapy combined with
target treatment for three circles followed by the sarcoma resectional surgeries.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Doxorubicin+Ifosfamide+Anlotinib(AI+A)
Description:
Doxorubicin（PLD） 40mg/㎡ d1, Ifosfamide（I） 1g/㎡ d1-5, Anlotinib（A）10mg d1-14 Q3weeks * 3
Circles
Arm group label:
The Neoadjuvant Therapy Group
Intervention type:
Procedure
Intervention name:
Radical Surgery
Description:
Radical sarcoma resectional surgery
Arm group label:
The Neoadjuvant Therapy Group
Arm group label:
The Surgery only Group
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.
Criteria for 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.
- In DDLPS
- 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.
- In LMS
- 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.
- Sarcoma without protruding across the diaphragm
- Possibility of R0/R1 resection evaluated through preoperative MDT(multi-disciplinary
team) discussion
- No multi-organ or system dysfunction/failure or patients with slight dysfunction of
organ/system could be easily recovered
- Tolerable of chemotherapy and surgery through MDT evaluation and tests.
- American Society of Anesthesiologist (ASA) ≤3
- Fully understand the informs and consent to participate in the study.
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Friendship Hospital
Address:
City:
Beijing
Country:
China
Facility:
Name:
Peking University First Hospital
Address:
City:
Beijing
Country:
China
Facility:
Name:
The Affiliated Hospital of Qingdao University
Address:
City:
Qingdao
Country:
China
Facility:
Name:
Shanghai Cancer Hospital, Minhang Branch
Address:
City:
Shanghai
Country:
China
Facility:
Name:
Shanghai Zhongshan Hospital
Address:
City:
Shanghai
Country:
China
Facility:
Name:
First Affiliated Hospital Xi'an Jiaotong University
Address:
City:
Xi'an
Country:
China
Start date:
November 1, 2022
Completion date:
November 1, 2027
Lead sponsor:
Agency:
Peking University International Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai Zhongshan Hospital
Agency class:
Other
Collaborator:
Agency:
The Affiliated Hospital of Qingdao University
Agency class:
Other
Collaborator:
Agency:
Peking University First Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai Cancer Hospital, China
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital Xi'an Jiaotong University
Agency class:
Other
Collaborator:
Agency:
Beijing Friendship Hospital
Agency class:
Other
Source:
Peking University International Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05844813
