Study of Induction Chemotherapy Followed by Radiochemotherapy in Locally Advanced Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT02984501|
Recruitment Status : Completed
First Posted : December 7, 2016
Last Update Posted : December 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Radiation: Radiation Drug: Chemotherapy||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Induction Chemotherapy Followed by Chemoradiotherapy in Patients With Borderline Resectable and Unresectable Locally Advanced Pancreatic Cancer|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Experimental: Single Arm
Patients treated with induction chemotherapy with gemcitabine and oxaliplatin; for patients without disease progression as detected through restaging exams, chemotherapy was followed by radiochemotherapy which consisted of conformal radiation therapy and concurrent gemcitabine at the dose of 600 mg/mq weekly.
Radiotherapy target volumes are established by CT scan and PET-CT scan. Radiotherapy is delivered with a total dose of 54-59 Gy with fractionation of 1.8 Gy daily for 5 days a week. The Planning Target Volume (PTV) is defined by CTV with a safety margin of 1cm in all directions to include organ motion and set-up errors. Organs at risk for radiation-induced side effects are contoured on the dose planning CT and dose volume histograms (DVH) are calculated. All treatments are delivered with a 15-MV linear accelerator (Varian Medical System) with a multifield isocentric technique using a multileaf collimator. A quality-control protocol are applied for all patients with periodical digital portal images to evaluate the precision of the set-up.
Other Name: Neoadjuvant therapy
The induction phase of the treatment plan is designed to administer gemcitabine 1000 mg/mq and oxaliplatin 100 mg/mq every 14 days for four doses. Chemotherapy concurrent to conformal radiation therapy is gemcitabine at the dose of 600 mg/mq weekly.
Other Name: Induction therapy
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: four months ]During treatment, patients are evaluated through a directed history, weekly physical examination and blood exams. The occurrence and nature of any adverse events are recorded in accordance with the National Cancer Institute Common Toxicity Criteria (version 4.0) scale. When multiple treatment-related adverse events of the same type occurred in the same patient, only the most severe ones are reported. Subsequently, the dose of chemotherapy is adjusted according to the number of occurrences of grade 2 or greater events.
- Overall Survival [ Time Frame: 3 years ]
- Progression-free survival [ Time Frame: 3 years ]
- metastases-free survival [ Time Frame: 3 years ]
- Incidence of Local-regional Tumor Control [ Time Frame: 3 years ]Patients are not considered to have local-regional control unless they achieve at least a partial response of their primary tumor or stable disease by imaging. Patients who do not achieve objective response are considered to have local-regional failure. Local-regional control rates are analyzed using the Kaplan-Meier method.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02984501
|Study Director:||Lucio Trodella, MD||Campus Bio-Medico University|