## Protocol Section
### Identification Module
**NCT ID:** NCT06416007

**Brief Title:** Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors

**Official Title:** A Phase 2 Study of Lattice Radiotherapy for Dose-Escalated Palliation of Bulky Tumors

#### Organization Study ID Info
**ID:** UCCC-RT-23-01
#### Organization
**Class:** OTHER
**Full Name:** University of Cincinnati
### Status Module
#### Completion Date
**Date:** 2027-06-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2027-01-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-06
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Cincinnati

#### Responsible Party

**Investigator Affiliation:** University of Cincinnati

**Investigator Full Name:** Andrew Frankart

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this research study is to determine if lattice radiation therapy (LRT) will provide better treatment for bulky (large) tumors than current standard of care radiotherapy.

**Detailed Description:** This will be a single-institution, single-arm Phase II trial with an anticipated total of 37 patients enrolled. Treatment will consist of 5 fractions of lattice radiation therapy delivered every other day. The primary endpoints will include the efficacy of lattice therapy as evaluated by ORR (CR or PR per RECIST criteria) at 60 days (2 months) post-treatment and safety. Toxicity will be evaluated at day 5 (+/- 2 days), day 15 (+/- 5 days), day 30 (+/- 5 days), and day 60 (+/- 7 days) post-completion of lattice therapy. This study will also include a translational analysis of the impact of lattice therapy on systemic immune responses.

### Conditions Module

**Conditions:**

- Cancer

- Metastatic Cancer

- Locally Advanced

- Locally Advanced Solid Tumor

- Locally Advanced Carcinoma

**Keywords:**

- Radiation

- Radiotherapy

- Bulky

- Spatial fractionation

- Lattice therapy

- Palliative

- Palliation

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 37

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Lattice radiation therapy (LRT) : 5 fractions

**Intervention Names:**

- Radiation: Lattice therapy (LRT)

**Label:** Lattice radiation therapy (LRT)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Lattice radiation therapy (LRT)

**Description:** 5 Fractions LRT

**Name:** Lattice therapy (LRT)

**Type:** RADIATION

### Outcomes Module

#### Other Outcomes

**Description:** Blood will be collected pre-treatment, after the last lattice fraction, and at 5 days post-lattice therapy for analysis via flow cytometry. Differences in immune anti-tumor responses be assessed between timepoints/tumor types. Increased immune anti-tumor responses after therapy compared to baseline are anticipated.

**Measure:** Impact of Lattice Therapy on Systemic Immune Anti-tumor Responses via analysis of peripheral blood samples.

**Time Frame:** Up to 5 days post-treatment

#### Primary Outcomes

**Description:** To evaluate the efficacy of lattice therapy in patients with bulky tumors, as measured by objective response rate (ORR) at 60 days post-treatment.

**Measure:** Overall Response Rate

**Time Frame:** 60 days post treatment

**Description:** To characterize the safety profile and adverse events (AEs) of lattice therapy.

**Measure:** Adverse Events

**Time Frame:** Up to 60 days post-treatment

#### Secondary Outcomes

**Description:** To assess overall survival (OS) following lattice therapy. Overall survival will be assessed via review of medical and vital records.

**Measure:** Overall Survival

**Time Frame:** 12 months post treatment

**Description:** To determine patient-reported quality of life outcomes after lattice therapy via the Functional Assessment of Cancer Therapy - General - 7 Item Version (FACT-G7) tool as a measure of global quality of life. This is measured on 5 point Likert-type scale ranging from 0-4. Higher scores reflect better QOL.

**Measure:** Patient-reported Quality of Life

**Time Frame:** 60 days post treatment

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Solid tumor malignancy with a clinical indication for radiation
* Patients must have measurable disease
* Target lesion(s) which are amenable to lattice therapy plan
* When applicable, target lesion for radiation amenable to immobilization during delivery of radiotherapy
* Age ≥18 years.
* ECOG Performance status ≤2
* Life expectancy greater than 3 months
* Women of child-bearing potential and men must agree to avoid conception via abstinence (ideal) or a method of birth control (e.g., hormonal or barrier method of birth control) prior to study entry and for at least 30 days after completion of lattice therapy administration.
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Patients receiving cytotoxic chemotherapy or known radiosensitizing agents within 5 days before or after lattice therapy.
* Patients with hematologic malignancies including lymphoma and leukemia as well as primary or metastatic central nervous system (CNS) malignancies.
* Patients with a history of conditions which predispose them to increased radiation toxicity
* Patients with known contraindications to radiation therapy
* Patients with uncontrolled intercurrent illness
* Pregnant women

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** cancer@uchealth.com

**Name:** UCCC Clinical Trials Office

**Phone:** 513-584-7698

**Role:** CONTACT

**Contact 2:**

**Name:** Andrew Frankart, MD

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Cincinnati

**Contacts:**

***Contact 1:***

- **Name:** Andrew Frankart, MD

- **Role:** CONTACT

**Country:** United States

**Facility:** University of Cincinnati Medical Center

**State:** Ohio

**Zip:** 45219

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009385

- Term: Neoplastic Processes

- ID: D000009369

- Term: Neoplasms

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M12307

- Name: Neoplasm Metastasis

- Relevance: HIGH

- As Found: Metastatic Cancer

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M12330

- Name: Neoplastic Processes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009362

- Term: Neoplasm Metastasis

### Misc Info Module

- Version Holder: 2024-05-31
