Low-dose Radiotherapy Plus Chemotherapy With Gem-based Doublets and Stereotactic Radiotherapy for Advanced Pancreatic Cancer

Not Applicable

Recruiting

• Conditions: Pancreatic Cancer
• Interventions: Radiation: LDR; Drug: Gem-based doublets; Radiation: SBRT

• Registration Number: NCT02416609
• Lead Sponsor: Azienda Ospedaliero-Universitaria di Modena

Brief Summary

Aim of this study is to evaluate if low-dose radiotherapy (LDR) can intensify local effect of a chemotherapy regimen with Gem-based doublets administered sequentially with stereotactic body radiotherapy (SBRT) and to assess the safety and efficacy of this combined treatment on patients affected by locally advanced pancreatic adenocarcinoma (LAPC).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2015-04-07
• Study First Submitted QC: 2015-04-14
• Study First Posted: 2015-04-15
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-08
• Last Update Posted: 2022-12-12
• Primary Completion: 2023-11
• Study Completion: 2024-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Pathologically confirmed adenocarcinoma of the pancreas
• Patients with unresectable disease based on institutional standardized criteria of unresectability or patients whose disease appeared potentially resectable on axial CT imaging but were found unresectable at surgery
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. Age ≥ 18
• Patients with biliary or gastroduodenal obstruction must have drainage or surgical bypass prior to starting treatment
• Patients with radiographically assessable disease
• Adequate bone marrow, hepatic and renal function: -Hemoglobin >10.0 g/dL, absolute neutrophil count > 1.5 x 10^9/L, platelet count > 100 x 10^9/L. -Aspartate transaminase (AST or SGOT) and alanine transaminase (ALT or SGPT) should be ≤ 3 x upper limit of normal (ULN). -Total bilirubin < 2 mg/dL. Patients with elevated bilirubin due to obstruction should be stented and their bilirubin should decrease to < 2 mg/dL prior to study entry. - Creatinine < 3 mg/dL or Creatinine clearance > 40 mL/min (calculated according to Cockroft and Gault)

Exclusion Criteria

• Evidence of metastatic disease in the major viscera or peritoneal seeding or ascites
• Gastric or duodenal obstruction
• Previous peripheral neuropathy
• Previous irradiation to the planned field; previous chemotherapy for pancreatic cancer
• Malignancy (within the past two years) except non-melanomatous skin cancer or carcinoma in situ of the cervix, uterus, or bladder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gem-based doublets with LDR & sequential SBRT	Gem-based doublets	Four Gem-based doublets cycles will be administered concurrent with LDR. If no progression, three fractions of SBRT will be administered.
Gem-based doublets with LDR & sequential SBRT	LDR	Four Gem-based doublets cycles will be administered concurrent with LDR. If no progression, three fractions of SBRT will be administered.
Gem-based doublets with LDR & sequential SBRT	SBRT	Four Gem-based doublets cycles will be administered concurrent with LDR. If no progression, three fractions of SBRT will be administered.

Primary Outcome Measures

Name	Time	Method
Progression-free survival	1 year	defined as the time from the initiation of therapy to the time of first event (local, regional or distant progression or death due to any cause). Patients without any such event at the time of data analysis will be censored at the last date they were known to be event-free. Patients with no tumor assessments after baseline will be censored at day 1

Secondary Outcome Measures

Name	Time	Method
Overall survival	1 year	defined as the time from the date of initiation of therapy to date of death due to any cause. Patients who is alive on the date of last follow-up were censored on that date
Toxicity(scored according to the National Cancer Institute Common Terminology Criteria for Adverse Events (v4.0))	every 3 months, up to 1 year	Acute gastrointestinal toxicity is defined as adverse events occurring \<3 months after SBRT; long-term toxicity was defined as those occurring after 3 months. Toxicity is scored according to the National Cancer Institute Common Terminology Criteria for Adverse Events (v4.0)

Trial Locations

Locations (1)

Azienda Ospedaliero-Universitaria Policlinico di Modena; 🇮🇹 Modena, MO, Italy