Study of Induction Chemotherapy Followed by Radiochemotherapy in Locally Advanced Pancreatic Cancer

NCT02984501 | Completed Phase 2

• 1 other identifier: 20/13 PAR ComEt CBM
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

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

Conditions

Pancreatic Cancer

Keywords

radiochemotherapy; neoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  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.

  four months

Secondary Outcomes (4)

• Overall Survival

  3 years

• Progression-free survival

  3 years

• metastases-free survival

  3 years

• Incidence of Local-regional Tumor Control

  3 years

Study Arms (1)

Single Arm

EXPERIMENTAL

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.

Radiation: Radiation; Drug: Chemotherapy

Interventions

Radiation RADIATION

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.

Also known as: Neoadjuvant therapy

Single Arm

Chemotherapy DRUG

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.

Also known as: Induction therapy

Single Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• I ECOG (Eastern Cooperative Oncology Group) performance status;
• adequate cardiac, liver and kidney function and a good bone marrow reserve.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Campus Bio-Medico University: lead

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiation; Neoadjuvant Therapy; Drug Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena; Combined Modality Therapy; Therapeutics

Study Officials

• Lucio Trodella, MD

  Campus Bio-Medico University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: December 7, 2016
• Study Start: March 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: December 7, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share