Clinical trial · Interventional
A Phase I Study Evaluating the Safety of Stereotactic Central Ablative Radiation Therapy (SCART) for Bulky Metastatic or Recurrent Cancer
INT-SCART-001: A Phase I Study Evaluating the Safety of Stereotactic Central Ablative Radiation Therapy (SCART) for Bulky Metastatic or Recurrent Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
We aim to evaluate the feasibility and toxicity of testing the tolerance and immunogenic effects of high-dose SCART radiotherapy in patients with bulky metastatic or recurrent cancer in the setting of a single-arm phase I clinical trial. The primary endpoint of the study was to determine dose-limiting toxicities (DLT)s and the Maximum Tolerated Dose (MTD) of SCART to bulky metastatic or recurrent cancers.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasms | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SCART radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SCART Arm
- description
- Single Arm patients will be treated with SCART to different dose levels.
- interventionNames
- Radiation: SCART radiation therapy
Primary outcomes (1)
- measure
- Toxicity
- timeFrame
- 12 months
- description
- radiation treatment-related grade 3+ non-hematologic adverse events
Secondary outcomes (3)
- measure
- Assessment of the antitumor effect
- timeFrame
- 12 months
- description
- PR or CR defined by radiology.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 3.1.1 Patients must have a history of histologically confirmed metastatic or recurrent cancers. 3.1.2 Patients must have measurable disease documented by CT and/or PET that is amenable for SCART radiation with the shortest axis of 3 cm or longer. 3.1.3 Patients must be 18 years of age or older, as this is not a pediatric protocol. There is no maximum age restriction. 3.1.4 Patients must have a life expectancy of at least 6 months in order for the study endpoints to be evaluable. 3.1.5 Patients must have a Zubrod/GOG performance status of 0 or 1. 3.1.6 Patients must have normal organ and marrow function as defined below: leukocyte\>3,000/m l absolute neutrophil count \>1,500/m l platelets \>100,000/m l bilirubin within normal institutional limits AST(SGOT)/ALT(SGPT) 2.5 X institutional upper limit of normal Creatinine within normal institutional limits OR; Creatinine clearance \> 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal. 3.1.7 Women of child-bearing potential will be asked to use adequate contraception. 3.1.8 Patients must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 3.2.1 Women who are pregnant or breastfeeding will be excluded. 3.2.2 Patients must not have any co-morbidity with life expectancy ≤ 6 months, or any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 3.2.3 Patients must not have active Crohn's disease or inflammatory bowel disease (IBD). \-
References
Publications (2)
- BACKGROUNDYan W, Khan MK, Wu X, Simone CB 2nd, Fan J, Gressen E, Zhang X, Limoli CL, Bahig H, Tubin S, Mourad WF. Spatially fractionated radiation therapy: History, present and the future. Clin Transl Radiat Oncol. 2019 Oct 22;20:30-38. doi: 10.1016/j.ctro.2019.10.004. eCollection 2020 Jan. No abstract available. PMID 31768424
- BACKGROUNDJiang L, Li X, Zhang J, Li W, Dong F, Chen C, Lin Q, Zhang C, Zheng F, Yan W, Zheng Y, Wu X, Xu B. Combined High-Dose LATTICE Radiation Therapy and Immune Checkpoint Blockade for Advanced Bulky Tumors: The Concept and a Case Report. Front Oncol. 2021 Feb 12;10:548132. doi: 10.3389/fonc.2020.548132. eCollection 2020. PMID 33643893