Radiotherapy following induction chemotherapy in locally advanced, unresectable pancreatic cance-a randomised phase 3 trial:Radiotherapy following induction chemotherapy compared with chemotherapy alone.
- Conditions
- ocally advanced non resectable pancreatic cancerMedDRA version: 21.0Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2009-014476-21-DE
- Lead Sponsor
- Dekan of the Medical Faculty of the University Erlangen-Nuremberg; Prof. Dr. med. Markus F. Neurath
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 830
• Age > 18 years
• histologically confirmed adenocarcinoma of the pancreas
• no evidence of distant metastasis based on computed tomography of the thorax and abdomen
• non resectable pancreatic cancer
• no evidence of peritoneal carcinosis
• ECOG-performance status = 2
• Signed study-specific consent form prior to therapy
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 830
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 830
• Pregnant or lactating/nursing women
• Fertile patients who refuse effective contraception during study treatment
• synchron second malignant neoplsam except basal cell carcinoma of the skin and carcinoma is situ of the cervix after curative therapy
• The Inclusion of patients with prior or concurrent malignancy (= 5 years prior to enrolment in study) must be discussed
• Chronic inflammatory disease of the intestine
• Known allergic reactions on study medication
• On-treatment participation on other trials
• Insufficient liver function: Bilirubin > 2,0 mg/dl; SGOT, SGPT, alkaline phosphatase, gGT more than 3 times upper limit of normal and after Stent implantation according to centre`s practice or after having consulted with PI); cirrhosis of the liver Child B and C
• Insufficient bone marrow function: WBC < 3,0 x 10^9/l, Platelets > 100 x 10^9/l
• Serum creatinine > 1,5 mg/dl, creatinin clearance < 60ml/min (or comparable test)
• Preexisting uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy, myocardial infarction within the past 6 months, unstable angina pectoris, congestive heart failure, New York Heart Association (NYHA) class III or IV heart disease
• Neurological and/or psychiatric diseases: stroke, dementia, epilepsy, psychosis
• Active intractable or uncontrollable infection, HIV-infection
• prior radiotherapy or chemotherapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evidence of survival benefit for locally advanced, non resectable and non metastatic pancreatic cancer after inductionchemotherapy followed by an additional chemoradiotherapy compared to chemotherapy alone ;Secondary Objective: Not applicable;Primary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: End of follow up
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Tumor-free survival<br>• Rate of local recurrence or local progression<br>• Rate of distant metastasis<br>• Acute and late toxicity of the chemoradiotherapy<br>• Quality of life<br>• Rate of remission<br>• Rate of curative resections (R0) after chemotherapy and chemoradiotherapy ;Timepoint(s) of evaluation of this end point: End of follow up