CompletedPhase 2

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

41 participantsStarted 2013-03

Plain-language 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

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Incidence of Treatment-Emergent Adverse Events

Timeframe: four months

Trial details

NCT IDNCT02984501

SponsorCampus Bio-Medico University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-08

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