Clinical trial · Interventional
Gemcitabine With or Without Capecitabine and/or Radiation Therapy or Gemcitabine With or Without Erlotinib in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery
Randomized Multicenter Phase III Study in Patients With Locally Advanced Adenocarcinoma of the Pancreas: Gemcitabine With or Without Chemoradiotherapy and With or Without Erlotinib. Intergroup Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which regimen of chemotherapy with or without erlotinib and/or radiation therapy is most effective in treating pancreatic cancer. PURPOSE: This randomized phase III trial is studying giving gemcitabine together with or without capecitabine and/or radiation therapy to see how well it works compared with giving gemcitabine together with or without erlotinib in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1 (A1) - Gemcitabine
- description
- Gemcitabine 2 months, then stop until progression
- interventionNames
- Drug: gemcitabine hydrochloride
- Other: laboratory biomarker analysis
- type
- EXPERIMENTAL
- label
- Arm 2 (B1) Gemcitabine + Erlotinib
- description
- B1 Gemcitabine + Erlotinib (100mg/d) 2 months, then erlotinib maintenance (150 mg/d)until progression
- interventionNames
- Drug: erlotinib hydrochloride
- Drug: gemcitabine hydrochloride
- Other: laboratory biomarker analysis
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the pancreas meeting the following criteria:
* De novo locally advanced disease
* Unresectable disease
* Stage III according to the UICC classification
* No distant metastases
* No localized stage IA-IIB or metastatic stage IV disease according to UICC classification
* Not considered for curative resection after pluridisciplinary discussion
PATIENT CHARACTERISTICS:
Inclusion criteria:
* ECOG performance status 0-2
* Life expectancy ≥ 12 weeks
* Polynuclear neutrophils ≥ 1.5 x 10\^9/L
* Platelets ≥ 100 x 10\^9/L
* Hemoglobin ≥ 9 g/dL
* Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
* For patients who have had a recent biliary drain and whose bilirubin is descending, a value of ≤ 3 times ULN is acceptable
* Creatinine ≤ 2 mg/dL
* AST and ALT ≤ 2.5 times ULN
* Alkaline phosphatase ≤ 5 times ULN
* Albumin ≥ 25 g/L
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after completion of therapy
Exclusion criteria:
* Diarrhea ≥ grade 2 and/or uncontrolled diarrhea
* Affiliated with a social security regime
* Unable to follow instructions for psychological, familial, or geographical reasons
* Allergic to one of the ingredients in erlotinib hydrochloride
* Cancer within the past 5 years, except for in situ cancer of the neck of the uterus or basal cell skin cancer
* Severe infection
* Ophthalmic disease (i.e., inflammation, keratopathy, or infection)
* Symptomatic coronary or cardiac insufficiency, myocardial infarction, or stroke within the last 6 months
* Unable to take oral treatments
* Gastrointestinal disorders that could be associated with absorption disorders
* Untreated gastric or duodenal ulcer
PRIOR CONCURRENT THERAPY:
* No prior radiotherapy (including abdominal radiotherapy) or chemotherapy for any reason
* No prior anti-epidermal growth factor-receptor therapyReferences
Publications (1)
- DERIVEDHammel P, Huguet F, van Laethem JL, Goldstein D, Glimelius B, Artru P, Borbath I, Bouche O, Shannon J, Andre T, Mineur L, Chibaudel B, Bonnetain F, Louvet C; LAP07 Trial Group. Effect of Chemoradiotherapy vs Chemotherapy on Survival in Patients With Locally Advanced Pancreatic Cancer Controlled After 4 Months of Gemcitabine With or Without Erlotinib: The LAP07 Randomized Clinical Trial. JAMA. 2016 May 3;315(17):1844-53. doi: 10.1001/jama.2016.4324. PMID 27139057