## Protocol Section
### Identification Module
**NCT ID:** NCT03158779

**Brief Title:** Evaluation of SBRT for Patients With Locally Advanced Unresectable Pancreatic Cancer

**Official Title:** Phase II Trial Evaluating Stereotactic Body Radiation Therapy (SBRT) After Induction Chemotherapy for Patients With Locally Advanced Unresectable Pancreatic Cancer

#### Organization Study ID Info
**ID:** 1736
#### Organization
**Class:** OTHER
**Full Name:** Istituto Clinico Humanitas
### Status Module
#### Completion Date
**Date:** 2022-07-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-09-15

**Type:** ACTUAL

**Last Update Submit Date:** 2022-09-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-07-01

**Type:** ACTUAL

#### Start Date
**Date:** 2017-05-10

**Type:** ACTUAL

**Status Verified Date:** 2022-09

#### Study First Post Date
**Date:** 2017-05-18
**Type:** ACTUAL
**Study First Submit Date:** 2017-05-04
**Study First Submit QC Date:** 2017-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Istituto Clinico Humanitas

#### Responsible Party

**Investigator Affiliation:** Istituto Clinico Humanitas

**Investigator Full Name:** Michele Tedeschi

**Investigator Title:** MD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The aim of this phase II study is to assess the efficacy and safety of sequentially integrated treatment of FOLFIRINOX or Gemcitabine-Abraxane and SBRT in patients with unresectable pancreatic cancer.

**Detailed Description:** The aim of this prospective mono-institutional phase II study is to assess the efficacy and safety of sequentially integrated treatment of FOLFIRINOX or Gemcitabine-Abraxane and SBRT with a total dose of 54 Gy in 6 fractions of 9 Gy /fractions in patients with locally unresectable pancreatic cancer.

Primary endpoint is to evaluate overall survival (OS); the overall survival time will be calculated from the start of chemotherapy to death. Secondary end points are to evaluate acute and late toxicities, freedom from local progression (FFLP) and progression free-survival (PFS). Acute and late toxicities will be scored according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Local progression will be defined according to RECIST criteria. Time to toxicity and time to local or distant progression will be defined from the start of chemotherapy.

Technical success will be defined as the ability to implant at least 2 fiducials in the tumor area. Migration will be defined as a change in inter-fiducial distance. Clinical success will be defined as the ability to guide the application of SBRT by using the fiducials. Any adverse event will be recorded (acute pancreatitis, clinically relevant upper GI bleeding requiring blood transfusion, abscesses in the area of the fiducials, sepsis).

### Conditions Module

**Conditions:**

- Pancreatic Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 45

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants received 4 months of FOLFIRINOX or Gemcitabine-Abraxane before SBRT was administered. A 3-weeks break from chemotherapy and restaging with thorax-abdominal CT scan to confirm the absence of distant metastases was required before SBRT delivery.

Before SBRT simulation, patients may will have implanted fiducial into the pancreatic tumor.

The SBRT schedule will be \[6 x 9 Gy = 54 Gy\] delivered in consecutive days.

**Intervention Names:**

- Combination Product: SBRT and chemotherapy

**Label:** SBRT and chemotherapy

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- SBRT and chemotherapy

**Description:** Patients affected by locally unresectable pancreatic cancer receive integrated treatment of FOLFIRINOX or Gemcitabine-Abraxane and a Stereotactic Body Radiation Therapy with a total dose of 54 Gy in 6 fractions of 9 Gy /fractions.

**Name:** SBRT and chemotherapy

**Type:** COMBINATION_PRODUCT

### Outcomes Module

#### Primary Outcomes

**Description:** Evaluation of SBRT after induction CT with FOLFIRINOX or Gemcitabine-Abraxane in terms of overall survival time that will be calculated from the start of chemotherapy to death.

**Measure:** Overall survival

**Time Frame:** 2 years

#### Secondary Outcomes

**Description:** Evaluation of early post treatment complications according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0.

**Measure:** Incidence of acute toxicities

**Time Frame:** 2 years

**Description:** Evaluation of late post treatment complications according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0.

**Measure:** Incidence of late toxicities

**Time Frame:** 4 years

**Description:** Evaluation of proportion of patients free from local progression according to RECIST criteria

**Measure:** Freedom from local progression in treated patients

**Time Frame:** 2 years

**Description:** Evaluation of proportions of patients alive and free form progression according to RECIST criteria

**Measure:** Progression free-survival of treated patients

**Time Frame:** 2 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Histologically and/or radiologically (CT scan and/or MRI scan and/or FDG-PET) proven unresectable locally advanced pancreatic cancer, discussed multidisciplinary by tumor board.
* Eighteen years of age or older,
* Minimum Karnofsky Performance Status of 70.
* Lesions cannot exceed 5 cm in maximum diameter.
* Absence of lymph-nodal metastases
* Patients received 4-6 months of FOLFIRINOX or Gemcitabine-Abraxane before SBRT was administered.
* Baseline total body CT scan performed no more than 2 months before treatment.
* Placing fiducial markers through endoscopes is permitted (EUS-guided fiducials placement before the treatment).
* Acceptable organ and bone marrow function.
* Ability to maintain the set-up position during RT.
* All patients give informed consent and sign a study-specific informed consent form.

Exclusion Criteria:

* Metastatic disease
* Prior abdominal radiotherapy
* Other malignancies diagnosed within 5 years
* Gastric or duodenal obstruction.
* Concurrent chemotherapy.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Rozzano

**Country:** Italy

**Facility:** Humanitas Research Hospital

**State:** Milan

**Zip:** 20089

#### Overall Officials

**Official 1:**

**Affiliation:** Istituto Clinico Humanitas

**Name:** Marta Scorsetti, MD

**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: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal 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: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M19537

- Name: Paclitaxel

- Relevance: LOW

- As Found: Unknown

- ID: M231

- Name: Albumin-Bound Paclitaxel

- Relevance: LOW

- As Found: Unknown

- ID: M2985

- Name: Gemcitabine

- Relevance: LOW

- As Found: Unknown

- ID: M271136

- Name: Folfirinox

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
