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Retroperitoneal SarcomaPhase 4NATARSNCT05844813

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

A Phase 4 study testing Doxorubicin+Ifosfamide+Anlotinib(AI+A) and Radical Surgery in people with Retroperitoneal Sarcoma, run by Peking University International Hospital at 6 sites in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Retroperitoneal Sarcoma
What is being tested?
Doxorubicin+Ifosfamide+Anlotinib(AI+A) and Radical Surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
6 sitesChina
Study dates
1 Nov 2022to 1 Nov 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 18Show fewer
  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

6 sites in 1 country

China6 sites

  • Beijing Friendship Hospital

    Beijing, Beijing Municipality

  • Peking University First Hospital

    Beijing, Beijing Municipality

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

  • Shanghai Cancer Hospital, Minhang Branch

    Shanghai, Shanghai Municipality

  • Shanghai Zhongshan Hospital

    Shanghai, Shanghai Municipality

  • First Affiliated Hospital Xi'an Jiaotong University

    Xi’an, Shanxi

Other trials in China

About this study

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

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:

Read more
  • 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.
Being tested
Doxorubicin+Ifosfamide+Anlotinib(AI+A), Radical Surgery
Keywords
Retroperitoneal Sarcoma, Neoadjuvant therapy, Target therapy, Survival

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Doxorubicin+Ifosfamide+Anlotinib(AI+A)Drug

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

  • Radical SurgeryProcedure or surgery

    Radical sarcoma resectional surgery

Study groups in NCT05844813
Study groupRoleWhat they receive
The Neoadjuvant Therapy GroupExperimentalNeoadjuvant 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
Receives: Drug: Doxorubicin+Ifosfamide+Anlotinib(AI+A); Procedure: Radical Surgery
The Surgery only GroupActive comparatorProcedure: Radical resectional surgery
Receives: Procedure: Radical Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 3-year Progression Free Survival(PFS)

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

    Measured: 3 years after first patient enrolled in

Secondary outcomes (7)

  1. 1-year PFS

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

    Measured: 1year after first patient enrolled in.

  2. 1 year Overall survival(OS)

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

    Measured: 1year after first patient enrolled in

  3. 3-year OS

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

    Measured: 3 years after first patient enrolled in

  4. 5-year PFS

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

    Measured: 5 years after first patient enrolled in.

  5. 5-year OS

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

    Measured: 5 years after first patient enrolled in

  6. Safety and toxicity of neoadjuvant therapy

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

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

  7. Postoperative morbidities

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2023
  2. Study start1 Nov 2022
  3. Primary completion1 Nov 2025 (estimated)
  4. Study completion1 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
102 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05844813
Sponsor's protocol ID
PKUIH-RPS01
Other IDs
Z221100007422042
Acronym
NATARS
Status last verified
May 2023
First submitted
16 Apr 2023
Last updated
12 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Doxorubicin+Ifosfamide+Anlotinib(AI+A) and Radical Surgery in people with Retroperitoneal Sarcoma, run by Peking University International Hospital at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

3-year Progression Free Survival(PFS) (time frame: 3 years after first patient enrolled in). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05844813.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.

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