Preoperative treatment for soft tissue sarcoma using radiation and Fluzoparib
Preoperative Moderately Fractionated Intensity-modulated Radiotherapy (IMRT) With/Without Concurrent Fluzoparil for Locally Extremity or Trunk Sarcoma
This study is testing if a combination of radiation therapy and a new drug called Fluzoparib can help improve treatment outcomes and quality of life for people with soft tissue sarcoma before surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Locations | 2 sites (Beijing, Beijing and 1 other locations) |
| Trial ID | NCT05938374 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and efficacy of preoperative moderately fractionated intensity-modulated radiation therapy (IMRT) combined with Fluzoparib Hydrochloride for patients with primary truncal or extremity soft tissue sarcoma. The trial aims to evaluate the quality of life and extremity function following this combination treatment, as well as to explore the mechanisms by which Fluzoparib enhances the effects of radiation. Additionally, the study will assess the correlation between MRI imaging, pathological findings, and local control of the disease.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with histologically confirmed soft tissue sarcoma of the trunk or extremities who are suitable for preoperative radiotherapy and conservative surgery.
Not a fit: Patients with contraindications to Fluzoparib or those with specific types of sarcoma like dermatofibrosarcoma protuberans may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes and quality of life for patients with soft tissue sarcoma.
How similar studies have performed: While the combination of radiotherapy and PARP inhibitors is being explored, this specific approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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. * Previous irradiation to the same area * radiological evidence of distant metastases * Other contraindications, can't tolerate operation or other treatment needed in this study.
Where this trial is running
Beijing, Beijing and 1 other locations
- Beijing Jishuitan Hospital — Beijing, Beijing, China (Recruiting)
- Cancer Hospital and Institute, National Cancer Center, Chinese Academy of Medical Sciences & Peking Union Medical Center — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Ning-Ning Lu, Dr. — Cancer Hospital and Institute, National Cancer Center, CAMS& PUMC, Beijing, China
- Study coordinator: Ning-Ning Lu, Dr.
- Email: Ning-Ning.Lu@hotmail.com
- Phone: 0118613051396569
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.