Randomized multicenter phase III study in patients with locally advanced adenocarcinoma of the pancreas: gemcitabine with or without chemoradiotherapy and with or without erlotinib

Trial Status Study closed (follow up) (published in JAMA 2016, P Hammel , F Huguet, JL Van Laethem et al.)
Phase Phase III
Type of cancer Pancreatic cancer
Study design

Multicenter prospective randomized international study.



To assess whether administrating a chemoradiotherapy in patients whose tumor is controlled after 4 months of induction chemotherapy (CT) increases survival compared to continue the same CT.


  • To assess whether erlotinib combined with gemcitabine and administered as maintenance treatment increases progression free survival compared to gemcitabine alone and without maintenance.
  • To evaluate the response rate in the CT and CRT arms.
  • To evaluate tolerance to erlotinib as maintenance treatment after the end of CT or CRT.
  • To study the predictive molecular factors (survivin, K-ras, EGFR, PTEN, AKT) on survival.
  • To define the prognostic impact of circulating tumor cell (CTC) detec
Inclusion Main criteria
  • Histologically proven adenocarcinoma of the pancreas
  • De novo locally advanced non-resectable tumor (stage III according to the UICC 2002 classification),
  • Measurable disease or evaluable (RECIST criteria)
  • No prior abdominal radiotherapy nor chemotherapy for any reason
  • Performance Status ECOG 0-2,
  • Adequate biological tests (blood, liver and renal).
Exclusion Main criteria
  1. Localized stage IA to IIB or metastatic cancer (stage IV) according to UICC
  2. Ampulloma and carcinoma of periampularry region
  3. Previous chemotherapy for any reason
  4. Previous abdominal radiotherapy
  5. Allergy to one of ingredients in erlotinib
  6. Prior treatment with an anti-EGFR
  7. Cancer within the 5 years before inclusion, except for in situ cancer of the neck of the uterus or basal cell skin cancer.
  8. Severe infection
  9. Ophthalmic disease (inflammation, kerotopathy or infection)
  10. Symptomatic coronary or cardiac insufficiency, myocardial infarction or stroke within the last 6 months.
  11. Unable to take oral treatments or with gastrointestinal disorders that could be associated with absorption disorders, untreated gastric or duodenal ulcer.
  12. Pregnancy or breast feeding
  13. Unable to follow for psychological, familial or geographical reasons.
  14. Not affiliated with a social security regime.
  15. Diarrhea > grade 2 and/or uncontrollable diarrhea
Treatment schedule

First randomization : gemcitabine vs gemcitabine plus erlotinib (followed by erlotinib maintenance in patients with controlled tumor).

Second randomization in patients with controlled tumor: two additional cycles of chemotherapy vs chemoradiotherapy

Study Period

End of inclusion: 17 February 2012 (target of inclusions reached)

Last patient last visit: 31 January 2014: 47 included patients

Publication in JAMA 2016 (see in  the beginning of this page)

Study Coordinators

CUB Hôpital Erasme, Prof. Dr. J-L. Van Laethem

Participating Groups


Participating centres
  1. CUB Erasme
  2. CHU Liège
  3. AZ Turnhout
  4. AZ Groeninge Kortrijk
  5. CHR Citadelle Liège
  6. UCL St-Luc
  7. Heilig Hart Roeselare
  8. ZOL Genk
  9. UZ Gent
  10. CHC St-Joseph Liège
  11. UZ Leuven
  12. OLV Aalst
  13. CH Jolimont
  14. UZ Antwerpen
  15. AZ Maria Middelares Gent
Protocol summary Link to
NCT number
EudraCT 2007-001174-81
Interest to participate
More info