Clinical trial NCT02984501: Study of Induction Chemotherapy Followed by Radiochemotherapy in Locally Advanced Pancreatic Cancer
Official title: Phase II Study of Induction Chemotherapy Followed by Chemoradiotherapy in Patients With Borderline Resectable and Unresectable Locally Advanced Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Keywords: radiochemotherapy
neoadjuvant therapy
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: There is no a clear consensus regarding the optimal treatment of locally advanced pancreatic disease. There is a potential role for neoadjuvant therapy to treat micrometastatic disease with chemotherapy, as well as for the treatment of local disease with radiotherapy. The investigators evaluated the safety and efficacy of induction chemotherapy with oxaliplatin and gemcitabine followed by a high weekly dose of gemcitabine concurrent to radiation therapy in patients with borderline resectable and unresectable locally advanced pancreatic cancer

Detailed description: Continued optimization in multimodality therapy and an accurate patient selection remain crucial points for the appropriate treatment of patients with pancreatic cancer.

In all patients an accurate pre-treatment staging was performed, including: physical examination, complete blood tests and tumor markers, endoscopic ultrasonography (EUS) with fine needle aspiration biopsy, multilayer CT scan, PET-CT (positron emission computed tomography) with 18F-2-fluoro-2-deoxy-D-glucose (FDG) and laparoscopy with peritoneal washing. Jaundiced patients before or during treatment underwent endoscopic biliary stenting.

Patients with the evidence of metastatic disease were excluded, and thus only a small number of patients was consequently enrolled with this neoadjuvant approach.

The induction phase of the treatment plan was designed to administer gemcitabine 1000 mg/mq and oxaliplatin 100 mg/mq every 14 days for four doses.

In the combined phase of the treatment all patients underwent simulation by using a Siemens 16-CT simulator (Siemens Medical System). Radiotherapy target volumes were established by CT scan and PET-CT scan.

Four weeks after the completion of radiochemotherapy, restaging, consisting of clinical examination, laboratory test, tumor markers, CT scan and PET-CT scan, was performed. Tumor response was defined in accordance with the World Health Organization (WHO) definition through CT scan and PET-CT scan. Surgery was considered in patients whose tumors were technically resectable.

After resection, patients were evaluated every three months by means of a standard surveillance protocol that included history and physical examination, cross-sectional imaging and measurement of serum markers, and the intervals were extended to six months after two years

Eligibility criteria: Inclusion Criteria:

* proven cytological or histological diagnosis of pancreatic ductal adenocarcinoma;
* borderline resectable or unresectable pancreatic tumours;
* age between 18 and 75 years;
* no previous radiochemotherapy to abdomen;
* 0-I ECOG (Eastern Cooperative Oncology Group) performance status;
* adequate cardiac, liver and kidney function and a good bone marrow reserve.

Exclusion Criteria:

* resectable and metastatic disease;
* previous or concomitant malignant disease;
* one or more of the following clinical conditions: infection, pregnancy or breast-feeding, liver failure, kidney failure, Pa O2 \< 65 mmHg, Pa CO2 \> 40 mmHg, mental disability.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: four months
Secondary outcomes:
measure: Overall Survival
timeFrame: 3 years
measure: Progression-free survival
timeFrame: 3 years
measure: metastases-free survival
timeFrame: 3 years
measure: Incidence of Local-regional Tumor Control
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Campus Bio-Medico University
name: Lucio Trodella, MD
role: STUDY_DIRECTOR
References: