Soft Tissue SarcomaPhase 2SPARE-03NCT05938374
Preoperative Moderately Fractionated IMRT for Locally Extremity or Trunk Sarcoma (SPARE-03)
A Phase 2 study testing Fluzoparib and Preoperative moderately fractionated radiotherapay in people with Soft Tissue Sarcoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 2 sites in China.
Trial summary
To investigate the safety and efficacy of preoperative moderately fractionated IMRT and concurrent Fluzoparib Hydrochloride for primary truncal or extremity soft tissue sarcoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- Fluzoparib and Preoperative moderately fractionated radiotherapay
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesChina
- Study dates
- 1 May 2023to 31 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 18 years.
- Histology proven soft tissue sarcoma of truncal or extremity, deemed appropriate for preoperative radiotherapy and conservative surgery by multidisciplinary discussion.
- ECOG 0-3
- Histology reviewed by reference pathologist
- Lesion can be assessed
- Can tolerate radiotherapy and Fluzoparib (Fluzoparib group)
- Agree contraception.
- Informed consent: All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed
Who cannot join
- No gross tumor post-resection in other center.
- Contraindications to Fluzoparib, including allergic to Fluzoparib, active bleeding, ulcer, enteric perforation, enteric obstruction, uncontrolled hypertension, Grade 3 to 4 cardiac insufficiency (per NYHA criteria), and severe hepatic or renal insufficiency (Grade 4), etc.
- Dermatofibrosarcoma protuberans(DFSP), Desmoids, etc.
- Benign histology
- Secondary cancer within 5 years (except cervical carcinoma in situ or early-stage skin basal cell carcinoma)
- STS can be cured by extensive operation alone.
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- Previous irradiation to the same area
- radiological evidence of distant metastases
- Other contraindications, can't tolerate operation or other treatment needed in this study.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Jishuitan Hospital
Beijing, Beijing Municipality
Cancer Hospital and Institute, National Cancer Center, Chinese Academy of Medical Sciences & Peking Union Medical Center
Beijing, Beijing Municipality
About this study
Official title: Preoperative Moderately Fractionated Intensity-modulated Radiotherapy (IMRT) With/Without Concurrent Fluzoparil for Locally Extremity or Trunk Sarcoma
To investigate the safety and efficacy of preoperative moderately fractionated IMRT and concurrent Fluzoparib Hydrochloride for primary truncal or extremity soft tissue sarcoma.
Read the detailed description
To investigate the safety and efficacy of preoperative moderately fractionated IMRT and concurrent Fluzoparib Hydrochloride for primary truncal or extremity soft tissue sarcoma; To investigate the Quality of life and extremity function post-combination treatment; To study the mechanism of radio-sensitizing effects of Fluzoparib Hydrochloride for primary truncal or extremity soft tissue sarcoma; To assess the relationship between the MRI imaging, pathological findings and local control.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- Fluzoparib, Preoperative moderately fractionated radiotherapay
- Keywords
- soft tissue sarcoma, preoperative radiotherapy, moderately fractionated RT, Complications, PARP inhibitor
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluzoparibDrug
Also called RT+Fluzoparib
One week before RT onset, during radiotherapy and 5 weeks post-RT, patients also take oral Fluzoparib (100mg, BID, five days per week).
Preoperative moderately fractionated radiotherapayRadiation
Also called RT
Patients will receive preoperative moderately fractionated radiotherapy (RT)(43.5Gy/15fr).
| Study group | Role | What they receive |
|---|---|---|
| Preoperative moderately fractionated RT with Fluzoparib | Experimental | Patients will receive preoperative moderately fractionated radiotherapy (RT)(43.5Gy/15fr). One week before RT onset, during radiotherapy and 5 weeks post-RT, patients also take oral Fluzoparib (100mg, BID, five days per week).
Wide resection surgery would be done around 6 -10 weeks post-RT. Receives: Drug: Fluzoparib; Radiation: Preoperative moderately fractionated radiotherapay |
| Preoperative moderately fractionated RT without Fluzoparib | Experimental | Patients will receive preoperative moderately fractionated radiotherapy (RT)(43.5Gy/15fr). No radio-sensitizing drugs was given.
Wide resection surgery would be done around 6 -10 weeks post-RT. Receives: Radiation: Preoperative moderately fractionated radiotherapay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major wound complications
Number of Participants with Major wound complications 4 months post-surgery
Measured: 4-months post-surgery
Secondary outcomes (7)
Acute toxicities
acute toxicities were evaluated as per CTCAE V5.0 criteria weekly during IMRT and 1 months after IMRT
Measured: pre-IMRT, weekly during IMRT, at the end of IMRT, 1 months post-IMRT
Late toxicities
late toxicities were evaluted as per CTCAE V5.0 criteria and RTOG scale after 6 months
Measured: 6 months, 9 months, 12 months, 18 months and 24 months after surgery
Quality of Life
EORTC QLQ-C30 questionnaire
Measured: pre-IMRT, end of IMRT, 1 months post-IMRT, and then 3 months, 6 months, 9 months, 12 months, 18 months and 24 months after surgery
Extremity function
MSTS questionnaire, TESS questionnaire
Measured: pre-IMRT, end of IMRT, 1 months post-IMRT, and then 3 months, 6 months, 9 months, 12 months, 18 months and 24 months after surgery
Pathological complete remission rate
No residual tumor cells were observed on post-operative specimens
Measured: 2 weeks after surgery
2-year overall survival
Incidence of participants who were alive
Measured: 2 year since enrollment
2-year local control
Incidence of participants who had no Local relapse
Measured: 2 year since enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start1 May 2023
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Preoperative moderately fractionated RT with Fluzoparib Preoperative moderately fractionated RT without Fluzoparib
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Jishuitan Hospital
- Responsible party
- Principal investigator, NINGNING LU, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Ning-Ning Lu, Dr., Principal investigator, Cancer Hospital and Institute, National Cancer Center, CAMS& PUMC, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05938374
- Sponsor's protocol ID
- NCC-4016
- Acronym
- SPARE-03
- Status last verified
- Dec 2025
- First submitted
- 21 Jun 2023
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Moderately Fractionated Intensity-modulated Radiotherapy (IMRT) With/Without Concurrent Fluzoparil for Locally Extremity or Trunk Sarcoma
- ClinicalTrials.gov ID
- NCT05938374
- Acronym / sponsor ID
- SPARE-03 / NCC-4016
- Conditions
- Soft Tissue Sarcoma
- Keywords
- soft tissue sarcoma, preoperative radiotherapy, moderately fractionated RT, Complications, PARP inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Beijing Jishuitan Hospital
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the safety and efficacy of preoperative moderately fractionated IMRT and concurrent Fluzoparib Hydrochloride for primary truncal or extremity soft tissue sarcoma.
Detailed description
To investigate the safety and efficacy of preoperative moderately fractionated IMRT and concurrent Fluzoparib Hydrochloride for primary truncal or extremity soft tissue sarcoma; To investigate the Quality of life and extremity function post-combination treatment; To study the mechanism of radio-sensitizing effects of Fluzoparib Hydrochloride for primary truncal or extremity soft tissue sarcoma; To assess the relationship between the MRI imaging, pathological findings and local control.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Preoperative moderately fractionated RT with Fluzoparib Preoperative moderately fractionated RT without Fluzoparib
| Arm | Type | Receives |
|---|---|---|
| Preoperative moderately fractionated RT with Fluzoparib | Experimental | Drug: Fluzoparib, Radiation: Preoperative moderately fractionated radiotherapayPatients will receive preoperative moderately fractionated radiotherapy (RT)(43.5Gy/15fr). One week before RT onset, during radiotherapy and 5 weeks post-RT, patients also take oral Fluzoparib (100mg, BID, five days per week). Wide resection surgery would be done around 6 -10 weeks post-RT. |
| Preoperative moderately fractionated RT without Fluzoparib | Experimental | Radiation: Preoperative moderately fractionated radiotherapayPatients will receive preoperative moderately fractionated radiotherapy (RT)(43.5Gy/15fr). No radio-sensitizing drugs was given. Wide resection surgery would be done around 6 -10 weeks post-RT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age older than 18 years.
- Histology proven soft tissue sarcoma of truncal or extremity, deemed appropriate for preoperative radiotherapy and conservative surgery by multidisciplinary discussion.
- ECOG 0-3
- Histology reviewed by reference pathologist
- Lesion can be assessed
Key exclusion criteria (9 listed)
- No gross tumor post-resection in other center.
- Contraindications to Fluzoparib, including allergic to Fluzoparib, active bleeding, ulcer, enteric perforation, enteric obstruction, uncontrolled hypertension, Grade 3 to 4 cardiac insufficiency (per NYHA criteria), and severe hepatic or renal insufficiency (Grade 4), etc.
- Dermatofibrosarcoma protuberans(DFSP), Desmoids, etc.
- Benign histology
- Secondary cancer within 5 years (except cervical carcinoma in situ or early-stage skin basal cell carcinoma)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluzoparibAlso: RT+FluzoparibOne week before RT onset, during radiotherapy and 5 weeks post-RT, patients also take oral Fluzoparib (100mg, BID, five days per week). | Drug | Preoperative moderately fractionated RT with Fluzoparib |
| Preoperative moderately fractionated radiotherapayAlso: RTPatients will receive preoperative moderately fractionated radiotherapy (RT)(43.5Gy/15fr). | Radiation | Preoperative moderately fractionated RT with Fluzoparib, Preoperative moderately fractionated RT without Fluzoparib |
Primary outcome
Major wound complications
Time frame: 4-months post-surgery
Number of Participants with Major wound complications 4 months post-surgery
7 secondary outcomes
Acute toxicities
Time frame: pre-IMRT, weekly during IMRT, at the end of IMRT, 1 months post-IMRT
Late toxicities
Time frame: 6 months, 9 months, 12 months, 18 months and 24 months after surgery
Quality of Life
Time frame: pre-IMRT, end of IMRT, 1 months post-IMRT, and then 3 months, 6 months, 9 months, 12 months, 18 months and 24 months after surgery
Extremity function
Time frame: pre-IMRT, end of IMRT, 1 months post-IMRT, and then 3 months, 6 months, 9 months, 12 months, 18 months and 24 months after surgery
Pathological complete remission rate
Time frame: 2 weeks after surgery
2-year overall survival
Time frame: 2 year since enrollment
2-year local control
Time frame: 2 year since enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ning-Ning Lu, Dr. principal investigator
Cancer Hospital and Institute, National Cancer Center, CAMS& PUMC, Beijing, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluzoparib and Preoperative moderately fractionated radiotherapay in people with Soft Tissue Sarcoma, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 2 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 8 inclusion and 9 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: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Major wound complications (time frame: 4-months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2025.