A Phase I Study Evaluating the Safety of Stereotactic Central Ablative Radiation Therapy (SCART) for Bulky Metastatic or Recurrent Cancer

NCT04881981 | Unknown Phase 1 DMC FDA Device

• 1 other identifier: INT-SCART-001
• Study Type: interventional
• Target: 12
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Malignant Neoplasms

Outcome Measures

Primary Outcomes (1)

• Toxicity

  radiation treatment-related grade 3+ non-hematologic adverse events

  12 months

Secondary Outcomes (3)

• Assessment of the antitumor effect

  12 months

• Evaluation of quality of life (QoL).

  12 months

• Biomarkers

  3-6 months

Study Arms (1)

SCART Arm

EXPERIMENTAL

Single Arm patients will be treated with SCART to different dose levels.

Radiation: SCART radiation therapy

Interventions

SCART radiation therapy RADIATION

We will deliver high dose radiation therapy using SCART method. Beam energies of 6Mv will be used. The high dose SCART therapy will be delivered using LINAC systems, as available and appropriate for each patient. The treatment plan used for each patient will be based on an analysis of the volumetric dose including DVH analyses of the PTV and critical normal structures.

SCART Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a history of histologically confirmed metastatic or recurrent cancers.
• 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.
• Patients must be 18 years of age or older, as this is not a pediatric protocol. There is no maximum age restriction.
• Patients must have a life expectancy of at least 6 months in order for the study endpoints to be evaluable.
• Patients must have a Zubrod/GOG performance status of 0 or 1.
• 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.
• Women of child-bearing potential will be asked to use adequate contraception.
• Patients must have the ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• Women who are pregnant or breastfeeding will be excluded.
• 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.
• Patients must not have active Crohn's disease or inflammatory bowel disease (IBD).

Sponsors & Collaborators

• Baptist Health, Louisville: lead
• Drexel University: collaborator
• Innovative Institute: collaborator
• University of Kentucky: collaborator
• Foshan Chancheng Hospital: collaborator

Study Sites (4)

Innovative Cancer Institute

Miami, Florida, 33143, United States

Location

Baptist health

Corbin, Kentucky, 40701, United States

Location

University of Kentucky Morehead Cancer Treatment Center

Morehead, Kentucky, 40351, United States

Location

Foshan Chancheng Hospital

Foshan, Guangdong, China

Location

Related Publications (2)

• Yan 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 BACKGROUND

• Jiang 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 BACKGROUND

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Weisi Yan, M.D.,Ph.D.

CONTACT

1-646-763-2973; Weisi.Yan@bhsi.com

XiaoDong Wu, Ph.D.

CONTACT

1-305-775-0333; DrXiaodongwu@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Baptist Corbin Radiation Oncology

Model Details: 3+3 phase one trial

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 11, 2021
• Study Start: June 5, 2021
• Primary Completion: May 5, 2022
• Study Completion: May 5, 2022
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 1 year after the publication and for 5 years.

Locations

US (3); CN (1)