||Study closed (follow up) (published in JAMA 2016, P Hammel , F Huguet, JL Van Laethem et al.)
|Type of cancer
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
- Localized stage IA to IIB or metastatic cancer (stage IV) according to UICC
- Ampulloma and carcinoma of periampularry region
- Previous chemotherapy for any reason
- Previous abdominal radiotherapy
- Allergy to one of ingredients in erlotinib
- Prior treatment with an anti-EGFR
- Cancer within the 5 years before inclusion, except for in situ cancer of the neck of the uterus or basal cell skin cancer.
- Severe infection
- Ophthalmic disease (inflammation, kerotopathy or infection)
- Symptomatic coronary or cardiac insufficiency, myocardial infarction or stroke within the last 6 months.
- Unable to take oral treatments or with gastrointestinal disorders that could be associated with absorption disorders, untreated gastric or duodenal ulcer.
- Pregnancy or breast feeding
- Unable to follow for psychological, familial or geographical reasons.
- Not affiliated with a social security regime.
- Diarrhea > grade 2 and/or uncontrollable diarrhea
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
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)
CUB Hôpital Erasme, Prof. Dr. J-L. Van Laethem
- CUB Erasme
- CHU Liège
- AZ Turnhout
- AZ Groeninge Kortrijk
- CHR Citadelle Liège
- UCL St-Luc
- Heilig Hart Roeselare
- ZOL Genk
- UZ Gent
- CHC St-Joseph Liège
- UZ Leuven
- OLV Aalst
- CH Jolimont
- UZ Antwerpen
- AZ Maria Middelares Gent
||Link to ClinicalTrials.gov
|Interest to participate