Randomized multicenter phase III study in patients with locally advancedadenocarcinoma of the pancreas: gemcitabine with or withoutchemoradiotherapy and with or without erlotinib

Phase 3

Completed

• Conditions: Locally Advanced Adenocarcinoma of the Pancreas; Cancer - Pancreatic; ocally Advanced Adenocarcinoma of the Pancreas

• Registration Number: ACTRN12609000158268
• Lead Sponsor: Australasian Gastro-Intestinal Trial Group (AGITG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-03-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Age older than 18yrs.
2. Patients with de novo locally advanced, histologically proven adenocarcinoma of the
pancreas without distant metastases (stage III according to the International Union against Cancer (UICC) classification) and
not considered for curative resection after pluridisciplinary discussion.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status no less then 2
4. Estimated life expectancy greater then 12 weeks
5. No prior radiotherapy nor chemotherapy for any reason
6. Signed informed consent form
7. Polynuclear neutrophils = 1.5 x 109/L, platelets = 100 x 109/L and hemoglobin = 9 g/dL
8. Total bilirubin smaller or equal to 1.5 N (N: upper limit of normal). In patients who have had a recent
biliary drain and whose bilirubin is descending, a value of smaller or equal to 3 N (50 µmoles/L) is
acceptable.
9. Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) smaller or equal to 2.5 N, alkaline phosphatase smaller or equal to 5 N
10. Albumin = 25 g/L
11. Creatinin £ 177 mmol/L (2 mg/dL)
12. Female patients who are not menopausal and their partners must accept to use effective
contraception throughout treatment and for 3 months after the end of treatment. All
patients who are capable of becoming pregnant must take a pregnancy test which is
negative within 72 hours before beginning treatment. The definition of effective
contraception is left up to the decision of the investigator.

Exclusion Criteria

1. Localized stage IA to IIB or metastatic cancer (stage IV) according to UICC
2. Previous chemotherapy for any reason
3. Previous abdominal radiotherapy
4. Allergy to one of ingredients in erlotinib
5. Prior treatment with an anti-EGFR
6. Cancer within the 5 years before inclusion, except for in situ cancer of the neck of the
uterus or basal cell skin cancer.
7. Severe infection
8. Ophthalmic disease (inflammation, keratopathy or infection)
9. Symptomatic coronary or cardiac insufficiency, myocardial infarction or stroke within the
last 6 months.
10. Unable to take oral treatments or with gastrointestinal disorders that could be associated
with absorption disorders, untreated gastric or duodenal ulcer.
11. Pregnancy or breast feeding
12. Unable to follow for psychological, familial or geographic reasons.
13. Not affiliated with a social security regime.
14. Diarrhea = grade 2 and/or uncontrolled diarrhoea

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess whether administrating a chemoradiotherapy (CRT) in patients whose tumor is controlled after 4 months of induction chemotherapy (CT) increases survival compared to continue the<br>same CT. Patient will undergo physical and clinical assessments using Eastern Cooperative Oncology Group Performance Status Scale <br>(ECOG PS), blood tests, computer topograhy scans of the abdomen and chest.[Evaluate weekly during induction of chemotherapy and chemoradiotherapy and 2 monthly during maintenance or follow-up. Follow up period, till disease progress or 2 years.]