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

Azienda Ospedaliero-Universitaria di Modena

Status: Enrolling

Conditions: Pancreatic Cancer

Treatments: Radiation: LDR; Radiation: SBRT; Drug: Gem-based doublets

Study type: Interventional

Funder types: Other

Identifiers

NCT02416609

BMed1

Details and patient eligibility

About

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).

Enrollment: 44 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Gem-based doublets with LDR & sequential SBRT

Experimental group

Description:

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

Treatment:

Drug: Gem-based doublets

Radiation: SBRT

Radiation: LDR