Pancreatic Carcinoma: Chemoradiation Compared With Chemotherapy Alone After Induction Chemotherapy

  • End date
    Apr 15, 2022
  • participants needed
  • sponsor
    University of Erlangen-Nürnberg Medical School
Updated on 15 October 2020
Oliver Ott, MD
Primary Contact
Erlangen Universit tsklinikum (8.7 mi away) Contact
+89 other location
ct scan
pancreatic adenocarcinoma
metastatic pancreatic cancer
resectable pancreatic cancer


This randomized trial examines the effectiveness of chemoradiotherapy compared to chemotherapy alone after induction chemotherapy with 3 cycles of gemcitabine or 6 cycles of FOLFIRINOX in patients with locally advanced, non resectable and non-metastatic pancreatic cancer. Chemotherapeutic agent in chemoradiotherapy is gemcitabine administered in 5 cycles, the agent and its administration for sole chemotherapy is determined by induction chemotherapy. Operability of tumor is evaluated at week 11 after randomisation. Patients will be followed for the duration of therapy and for 5 years after the last study treatment. Overall survival at the end of follow up is defined as primary endpoint. Secondary endpoints are tumor-free survival, rate of local recurrence or local progression, rate of distant metastasis, acute and late toxicity of the chemoradiotherapy, quality of life, rate of remission, rate of curative resections (R0) after chemotherapy and chemoradiotherapy. It is planned to include a total number of 830 patients.

Treatment Induction chemotherapy with gemcitabine or FOLFIRINOX, Radiotherapy, 28 x 1.8 Gy, Chemotherapy, gemcitabine, Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy
Clinical Study IdentifierNCT01827553
SponsorUniversity of Erlangen-Nürnberg Medical School
Last Modified on15 October 2020

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.


Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Pancreatic Cancer or Pancreatic Disorders or Islet Ce417ll Cancer or Neoplasm of unspecified nature of digestive system or Pancreatic disorder or Dige...?
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

Exclusion Criteria

fertile patients who refuse effective contraception during study treatment
synchron second malignant neoplasm except basal cell carcinoma of the skin and carcinoma in 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 (after Stent implantation in case of obstructive jaundice); 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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Phone Email

Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more
Step 4 Get your study results

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer


user name

Annotated by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No made yet