Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000158268
Ethics application status
Approved
Date submitted
2/03/2009
Date registered
25/03/2009
Date last updated
1/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomized multicenter phase III study in patients with locally advanced
adenocarcinoma of the pancreas: gemcitabine with or without
chemoradiotherapy and with or without erlotinib
Scientific title
Phase III study to determine the role of radiotherapy in patients with locally advanced pancreatic cancer: gemcitabine with and without chemoradiotherapy and with or without erlotinib
Secondary ID [1] 252251 0
None.
Universal Trial Number (UTN)
Trial acronym
LAP07
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally Advanced Adenocarcinoma of the Pancreas 4375 0
Condition category
Condition code
Cancer 4655 4655 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Gemcitabine 1000mg/m2 30 minutes infusion on days 1,8,15,22,29,36,43, after first evaluation continue gemcitabine on days 57,64,71,85,92,99 and erlotinib 100mg dose per day for 4 months then 150 mg/day, orally, as maintanence therapy, for two years (end of study). Should the tumour NOT increase in size and/or spread to surrounding structure, then patients are FURTHER either randomised to 1) continuing with chemoradiation (radiation 54 Gy and 2x800mg/m2 of Capecitabine, orally, 5 days a week, over 6 weeks) and erlotinib maintenance (after 1 month break from completion of chemoradiation, patients will take 150mg of erlotinib orally, for 2 years, stopping erlotinib maintanence, if tumour increases in size or spread to surrounding structure) or 2) just erlotinib (100mg dose per day, orally, for 2 months) .
Intervention code [1] 4106 0
Treatment: Drugs
Intervention code [2] 4107 0
Treatment: Other
Comparator / control treatment
Gemcitabine 1000mg/m2 30 minutes infusion on days 1,8,15,22,29,36,43, after first evaluation continue gemcitabine on days 57,64,71,85,92,99, 113,120,127,141,148,155. Stop treatment when the tumour increases in size and/or spread to surrounding structures. Should tumour not increase in size or spread to surrounding structures, then patients are FURTHER randomised into 1) chemoradiotherapy (54 Gy and 2X800mg of Capecitabine per day, 5 days a week for 6 weeks) or 2) Gemcitabine (1000mg infusion of gemcitabine on day 113,120,127,141,148 and 155)
Control group
Active

Outcomes
Primary outcome [1] 5492 0
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
same CT. Patient will undergo physical and clinical assessments using Eastern Cooperative Oncology Group Performance Status Scale
(ECOG PS), blood tests, computer topograhy scans of the abdomen and chest.
Timepoint [1] 5492 0
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.
Secondary outcome [1] 9251 0
To study the predictive molecular factors (survivin, v-Ki-ras2 Kirsten rat sarcoma (K-ras), Epidermal Growth Factor Receptor (EGFR), phosphatase and tensin homolog (PTEN), AKT) on survival. Levels of messenger ribonucleic acid (mRNA) will be measured using pancreatic tissue samples and correlated to patient treatment outcome.
Timepoint [1] 9251 0
End of follow up period - 2 years
Secondary outcome [2] 9252 0
To evaluate tolerance to erlotinib as maintenance treatment after the end of CT or CRT. Monitering by health care professionals as well as use of Serious Adverse Events forms.
Timepoint [2] 9252 0
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.
Secondary outcome [3] 9253 0
To evaluate the response rate in the CT and CRT arms. Patient will undergo physical and clinical assessments using Eastern Cooperative Oncology Group Performance Status Scale
(ECOG PS), blood tests, computer topograhy scans of the abdomen and chest.
Timepoint [3] 9253 0
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.
Secondary outcome [4] 9254 0
To assess whether erlotinib combined with gemcitabine and administered as maintenance
treatment increases progression free survival compared to gemcitabine alone and without
maintenance. Patient will undergo physical and clinical assessments using Eastern Cooperative Oncology Group Performance Status Scale
(ECOG PS), blood tests, computer topograhy scans of the abdomen and chest.
Timepoint [4] 9254 0
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.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2010
Actual
15/07/2010
Date of last participant enrolment
Anticipated
Actual
15/12/2011
Date of last data collection
Anticipated
Actual
31/12/2013
Sample size
Target
60
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
NSW,VIC,QLD,WA
Recruitment outside Australia
Country [1] 1599 0
New Zealand
State/province [1] 1599 0

Funding & Sponsors
Funding source category [1] 4564 0
Government body
Name [1] 4564 0
Cancer Australia
Country [1] 4564 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Gastro-Intestinal Trial Group (AGITG)
Address
National Health and Medical Research Council (NHMRC) Clinical Trial Centre
Locked Bag 77
Camperdown NSW 1450
Country
Australia
Secondary sponsor category [1] 4254 0
None
Name [1] 4254 0
Address [1] 4254 0
Country [1] 4254 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293731 0
Cancer Institure NSW CREC
Ethics committee address [1] 293731 0
Ethics committee country [1] 293731 0
Australia
Date submitted for ethics approval [1] 293731 0
29/05/2009
Approval date [1] 293731 0
12/10/2009
Ethics approval number [1] 293731 0
HREC/09/CIC/15

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29317 0
Prof David Goldstein
Address 29317 0
Prince of Wales Hospital, Barker St, Randwick NSW 2031
Country 29317 0
Australia
Phone 29317 0
+612 9565 5000
Fax 29317 0
Email 29317 0
[email protected]
Contact person for public queries
Name 12564 0
LAP07 Trial Coordinator
Address 12564 0
NHMRC Clinical Trial Centre
Locked Bag 77
Camperdown 1450
NSW
Country 12564 0
Australia
Phone 12564 0
+61 2 9562 5000
Fax 12564 0
+61 2 9562 5094
Email 12564 0
[email protected]
Contact person for scientific queries
Name 3492 0
Prof David Goldstein
Address 3492 0
Prince of Wales Hospital, Barker St, Randwick NSW 2031, Australia
Country 3492 0
Australia
Phone 3492 0
+61 2 9382 2581
Fax 3492 0
Email 3492 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.