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Enrolling by Invitation

NCT Number: NCT05844813

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

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.

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Key information

Conditions

Retroperitoneal Sarcoma

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beijing Friendship Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doxorubicin+Ifosfamide+Anlotinib(AI+A)

Drug

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

Radical surgery

Procedure

Radical sarcoma resectional surgery

Primary outcomes

  1. 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. 1-year PFS

    Time frame: 1year 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.

  2. 1 year Overall survival(OS)

    Time frame: 1year after first patient enrolled in

    OS will be measured from the date of surgery to the date of death, whatever the causes of death.

  3. 3-year OS

    Time frame: 3 years after first patient enrolled in

    OS will be measured from the date of surgery to the date of death, whatever the causes of death.

  4. 5-year PFS

    Time frame: 5 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.

  5. 5-year OS

    Time frame: 5 years after first patient enrolled in

    OS will be measured from the date of surgery to the date of death, whatever the causes of death.

  6. Safety and toxicity of neoadjuvant therapy

    Time frame: 1-d, 7-d after the first date of each neoadjuvant therapy session.

    Safety and toxicity will be evaluated through blood tests, echocardiography, ECG, etc.

  7. Postoperative morbidities

    Time frame: 30-d, 90-d, 1-year separately after the date of surgery.

    Operative outcomes including morbidities will be collected and compared in two groups.

Sponsors and collaborators

Lead sponsor

Peking University International Hospital

Other

Collaborators

  • Beijing Friendship Hospital
  • First Affiliated Hospital Xi'an Jiaotong University
  • Peking University First Hospital
  • Shanghai Cancer Hospital, China
  • Shanghai Zhongshan Hospital
  • The Affiliated Hospital of Qingdao University

Registry information

Official study title

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

Acronym: NATARS

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
May 6, 2023
Registry last updated
May 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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