## Protocol Section
### Identification Module
**NCT ID:** NCT06427460

**Brief Title:** Central-boost Ablative Radiation Therapy for Solid Tumors (CBART)

**Official Title:** Central-boost Ablative Radiation Therapy for Large Tumors or Tumors Adjacent to Organs at Risk

#### Organization Study ID Info
**ID:** Changhai Hospital NMU
#### Organization
**Class:** OTHER
**Full Name:** Changhai Hospital
### Status Module
#### Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-19

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-12

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-19
**Study First Submit QC Date:** 2024-05-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Changhai Hospital

#### Responsible Party

**Investigator Affiliation:** Changhai Hospital

**Investigator Full Name:** Zhang Huo Jun

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** In the case of large tumors or tumors closely adjacent to organs at risk, ablative doses offered by stereotactic body radiation therapy (SBRT) could not be delivered. Therefore, a technique that could provide high radiation doses to tumors without increasing of risks of severe adverse effects is required.

**Detailed Description:** Regarding the advanced stage tumor, especially tumors with large volumes or closely adjacent to organs at risk, patients are not candidates for surgical resection. Therefore, raduitherapy may be the optimal local therapy to ameliorate symptoms and be combined with systemic therapy, including chemotherapy, targeted therapy or immunotherapy. However, for those tumors, ablative doses could not be given due to large volumes and abutting to organs at risk.

In order to solve the problem, spatially fractionated radiation therapy (SFRT) is used. In details, it was performed based on grid or lattice, which creates several cylindrical high-radiation-dose areas in tumors. Nevertheless, the ablative dose areas are limited albeit with SFRT, which may not greatly improve tumor local. Hence, we create an inner and complete inner gross tumor volume that would be delivered ablative radiation doses, which is named as central-boost ablative radiation therapy (CBART). We aim to investigate the efficacy and safety of CBART in large tumors or tumors adjacent to organs at risk.

### Conditions Module

**Conditions:**

- Pancreatic Cancer

**Keywords:**

- pancreatic cancer

- stereotactic body radiation therapy

- inner gross tumor volume

- central boost

- ablative radiation dose

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 67

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Central-boost ablative doses delivered by SBRT.

**Intervention Names:**

- Radiation: Central-boost ablative dose delivered by stereotactic body radiation therapy

**Label:** stereotactic body radiation therapy

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- stereotactic body radiation therapy

**Description:** An inner and complete gross tumor volume (iGTV) is created within the gross tumor volume (GTV). For the liver or lung tumor, the convetional radiation dose is 35-45Gy/5f. Regarding the pancreatic tumor or retroperitoneal tumor, the radiation dose is 30-40Gy/5f. Hence, the radiation dose of iGTV should not be less than 120% of the dose of GTV.

**Name:** Central-boost ablative dose delivered by stereotactic body radiation therapy

**Type:** RADIATION

### Outcomes Module

#### Primary Outcomes

**Description:** The proportion of patients without tumor local progression at one year. The progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

**Measure:** One-year local control will be determined.

**Time Frame:** 1 year

#### Secondary Outcomes

**Description:** The time from the enrollment to death.

**Measure:** Overall survival will be determined.

**Time Frame:** 2 years

**Description:** The time from the enrollment to documentation of any clinical or radiological disease progression or death, whichever occurred first. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

**Measure:** Progression free survival will be determined.

**Time Frame:** 2 years

**Description:** Treatment-related adverse effects are determined by National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.

**Measure:** Treatment related adverse events

**Time Frame:** 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Aged 18-75 years.
* Pathologically confirmed lung, liver, pancreas or retroperitoneal malignant tumor.
* Oligometastasis in the case of metastatic tumor
* the shortest diameter ≥2cm or the distance from the tumor to the organs at risk less than 5mm
* ECOG of 0 to 1 point
* No abnormality in blood routine test, liver and kidney function test and coagulation test (White blood cell count ≥4.0×10\^9/L, neutrophil count ≥2.0×10\^9, hemoglobin level ≥100g/L, platelet count ≥100×10\^9/L, ALT and AST level \< 2.5 times the upper limit of normal, total bilirubin and creatinine level within the normal, international normalized ratio \<2)

Exclusion Criteria:

* History of radiotherapy for the lesion
* History of tumor within 5 years
* ECOG ≥2 points
* Significant abnormality in blood routine test, liver and kidney function test and coagulation test
* Active inflammatory bowel disease in the case of pancreas or retroperitoneal tumor
* Gastrointestinal bleeding or perforation within 6 months in the case of pancreas or retroperitoneal tumor
* Infections required antibiotics
* Heart or respiratory insufficiency
* Pregnant or breastfeeding women

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** zhuxiaofei_zxf@163.com

**Name:** Xiaofei Zhu

**Phone:** 86-021-31162222

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Email:** zhuxiaofei_zxf@163.com

- **Name:** Xiaofei Zhu

- **Phone:** 86-021-31162222

- **Role:** CONTACT

***Contact 2:***

- **Name:** Huojun Zhang, M.D.

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** Huojun Zhang

**State:** Shanghai

**Status:** RECRUITING

**Zip:** 200433

#### Overall Officials

**Official 1:**

**Affiliation:** Changhai Hospital

**Name:** Huojun Zhang, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004701

- Term: Endocrine Gland Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000010182

- Term: Pancreatic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13110

- Name: Pancreatic Neoplasms

- Relevance: HIGH

- As Found: Pancreatic Cancer

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7863

- Name: Endocrine Gland Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13102

- Name: Pancreatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4387

- Name: Pancreatic Cancer

- Relevance: HIGH

- As Found: Pancreatic Cancer

### Condition Browse Module - Meshes

- ID: D000010190

- Term: Pancreatic Neoplasms

### Intervention Browse Module - Browse Branches

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
