Soft Tissue Sarcoma Adult Clinical Trial
— SADDRIN-1Official title:
Sarcomas and DDR-Inhibition; a Neoadjuvant Phase I Combined Modality Study.
NCT number | NCT05116254 |
Other study ID # | M21SAD |
Secondary ID | |
Status | Recruiting |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | July 18, 2022 |
Est. completion date | July 1, 2028 |
To assess the safety and tolerability profile, in the pre- and perioperative period (up to 30 days post-surgery), of combined modality treatment (CMT) by administering AZD1390 with or without durvalumab and RT concurrently treating newly diagnosed, non-metastatic soft tissue sarcoma patients with DDRi-based CMT, in the specific context of systemic toxicities, wound healing post-surgery and in defining the RP2D for the combinations to support further clinical evaluation.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | July 1, 2028 |
Est. primary completion date | March 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Histologically confirmed newly diagnosed intermediate to high grade soft tissue sarcoma localized to the extremities, for which the standard treatment is a combination of RT and surgery (in other words deep seated and/or > 5cm in largest tumor diameter and/or an anticipated close resection margin and/or grade II/III according to the FNCLCC definition); - Patients staged by at least a CT scan of the chest (and a CT scan of the abdomen, if deemed indicated according to local practices, e.g. in case of a myxoid liposarcoma). Staging may also be performed by FDG-PET scanning and or total body MRI scans. This staging procedure should not reveal metastatic disease. If, however, a low metastatic burden is detected such that this does not preclude the application of both preoperative RT and definitive surgery, patients are allowed to participate; - WHO Performance Status = 2; - Able and willing to undergo preoperative RT; - Able and willing to undergo definitive surgery; - Able and willing to comply with regular follow-up visits; - Able and willing to swallow and retain oral medication; - Age = 18 years; - Body weight >30kg; - Must have a life expectancy of at least 12 weeks; - Adequate organ function as defined in Table 5; - Signed written informed consent prior to any study specific procedures or sampling Exclusion Criteria: - Patients with any type soft tissue sarcoma located above the clavicles. - Prior malignancies; except another malignancy and disease-free for = 5 years, or completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma; - Patients with recurrent sarcomas who underwent prior RT to the target lesion (if the primary sarcoma was managed by surgery only and no perioperative RT, patients are eligible); - Ewing sarcoma and other PNET family tumors, rhabdomyosarcomas (both pediatric and adult), bone sarcomas; - Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial; - Female patients who are pregnant or breast feeding; - Intention to perform an isolated limb perfusion, instead of a tumor resection; - Neoadjuvant chemotherapy to be scheduled between end of RT and definitive surgery is not allowed. (neoadjuvant chemotherapy before start of study RT is allowed); - Concomitant treatment with medicines listed as 'prohibited' or 'excluded'; - Treatment with moderate and strong inhibitors or inducers of CYP3A4 within 2 weeks before the first dose of study treatment (3 weeks for St John's Wort); Additional criteria for durvalumab plus AZD1390: - Past medical history of allogenic organ transplantation; - Past medical history of leptomeningeal carcinomatosis; - Past medical history or active autoimmune or inflammatory disorders - History or presence of primary immunodeficiency - Presence of active hepatitis infections or HIV - Treatment with or prior use of immunosuppressive medication within 2 weeks before the start of treatment - Prior treatment with anti-PD-1, anti PD-L1 or anti CTLA-4 immunotherapy |
Country | Name | City | State |
---|---|---|---|
Netherlands | Antoni van Leeuwenhoek | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
The Netherlands Cancer Institute | Leiden University Medical Center, University Medical Center Nijmegen |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Drug safety | all adverse events | 2 years | |
Primary | Drug tolerability | adverse events and more specific woundhealing | 30 days | |
Secondary | Tumor regression | pathological remission | After 5 weeks of RT and DDRi-based drug treatment | |
Secondary | Local control rates | Histopathological response and MRI | 2 years | |
Secondary | Rate of R0 resection | Histological examination of surgical specimens | Directly after surgery | |
Secondary | Rate of R1 resection | Histological examination of surgical specimens | Directly after surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04577014 -
Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma
|
Phase 1/Phase 2 | |
Recruiting |
NCT04656262 -
Low Dose Continuous Cyclophosphamide vs Standard Doxorubicin in Advanced Sarcoma Elderly Patients
|
Phase 3 | |
Recruiting |
NCT03077178 -
Impact of Locoregional Treatment of Soft Tissue Sarcoma on Status of Patients Aged 70 Years and Over
|
N/A | |
Not yet recruiting |
NCT06110650 -
A Study of Surufatinib in the Treatment of Advanced Soft Tissue Sarcoma
|
N/A | |
Terminated |
NCT03735758 -
Quality of Life in Patients With Non-adipocyte Soft Tissue Sarcoma Under Palliative Chemotherapy or Pazopanib
|
Phase 4 | |
Not yet recruiting |
NCT03951571 -
Efficacy and Safety of Anlotinib in Adjuvant Therapy for High-grade Soft Tissue Sarcoma
|
Phase 2 | |
Enrolling by invitation |
NCT03134742 -
Radiation Effects on Bone
|
||
Not yet recruiting |
NCT06252727 -
Fluorescent Aided Resection and Evaluation of Soft Tissue Sarcomas (FLARES)
|
Phase 1 | |
Recruiting |
NCT04617327 -
Pre-operative RadiothErapy for Soft Tissue SarcOmas
|
N/A | |
Recruiting |
NCT06385288 -
Blood and Tissue Extraction for Immunological Examinations During Neoadjuvant Therapy of Soft Tissue Sarcomas
|
N/A | |
Active, not recruiting |
NCT03526679 -
Lenvatinib and Eribulin in Advanced Soft Tissue Sarcoma
|
Phase 1/Phase 2 | |
Recruiting |
NCT04008238 -
Prospective Identification of Predictive Biomarkers of Trabectedin Efficacy in Non-L Soft-tissue Sarcoma Patients
|
N/A | |
Recruiting |
NCT04095208 -
Combination of Nivolumab Plus Relatlimab in Patients With Advanced or Metastatic Soft-tissue Sarcoma: a Proof-of-concept Randomized Phase II Study
|
Phase 2 | |
Recruiting |
NCT04330456 -
Combined Treatment of Patients With Soft Tissue Sarcoma Including Preoperative Stereotactic Radiation Therapy and Postoperative Conformal Radiation Therapy
|
N/A | |
Completed |
NCT03833037 -
Study of a Cohort of Cases of Synovial Sarcoma Treated in the Orthopedic Surgery and Traumatology Department of the Hospital de Sant Pau Between 1983 and 2016
|
||
Completed |
NCT03056599 -
Precise Local Injection of Anti-cancer Drugs Using Presage's CIVO Device in Soft Tissue Sarcoma
|
Phase 1 | |
Recruiting |
NCT05961761 -
Propranolol and Pembrolizumab in Advanced Soft Tissue Sarcoma Patients
|
Phase 2 | |
Recruiting |
NCT06273852 -
A Study of the Intratumoral Microdose Administration of PBA-0405 in Patients With Solid Tumors
|
Early Phase 1 | |
Recruiting |
NCT05182164 -
Combination of Pembrolizumab and Cabozantinib in Patients With Advanced Sarcomas
|
Phase 2 | |
Withdrawn |
NCT03104335 -
Apatinib for Advanced Soft Tissue Sarcoma Patients: a Phase 2, Multicenter Trial
|
Phase 2 |