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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01486459




Registration number
NCT01486459
Ethics application status
Date submitted
4/12/2011
Date registered
6/12/2011
Date last updated
18/03/2015

Titles & IDs
Public title
A Feasibility Trial Using Lithium As A Neuroprotective Agent In Patients Undergoing Prophylactic Cranial Irradiation For Small Cell Lung Cancer
Scientific title
A Feasibility Trial Using Lithium As A Neuroprotective Agent In Patients Undergoing Prophylactic Cranial Irradiation For Small Cell Lung Cancer
Secondary ID [1] 0 0
ALCC 11.01
Universal Trial Number (UTN)
Trial acronym
TULIP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lithium

Experimental: PCI with lithium - Prophylactic cranial irradiation Lithicarb® tablets 250mg/day for 6 weeks. Initial dosing will be 250mg given once daily, and increased by 250 - 500 mg increments depending on plasma levels.

No Intervention: Standard - Prophylactic cranial irradiation alone.


Treatment: Drugs: Lithium
250 mg daily for 6 weeks, increased 250 - 500 mg depending on plasma levels.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility of a project design where the patients are randomized into lithium or placebo
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Neurocognition
Timepoint [1] 0 0
1 year

Eligibility
Key inclusion criteria
- Histologically or cytologically confirmed high grade small cell neuroendocrine
carcinoma.

- Patients can either have:

- Limited stage disease with CR or PR OR

- Extensive stage disease with CR or good PR

- Patients must have discontinued other chemotherapies at least 3 weeks prior to
randomisation.

- Prior radiation therapy to the chest is allowed but must be completed at least 3 weeks
prior to randomisation.

- ECOG Performance Status 0 to 2.

- Adequate bone marrow, liver, and renal function as assessed by the following:

- Hemoglobin = 9.0 g/dl

- Absolute neutrophil count (ANC) = 1,500/mm3

- Platelet count = 100,000/mm3

- Total bilirubin = 2.0 times the upper limit of normal

- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 x upper
limit of normal (= 5x ULN for patients with liver involvement)

- International Normalized Ratio for Prothrombin Time (PT-INR) = 1.5 and activated
partial prothrombin time (aPTT) within 5% of normal limits for patient NOT on
anticoagulation.

- Estimated Glomerular Filtration Rate (eGRF) > 50 ml/min .

- Male or female aged >18 years

- Patients must be able and willing to sign a written informed consent. A signed
informed consent must be appropriately obtained prior to any study specific
procedures.

- Patients must be able to swallow and retain oral medication.

- Women of childbearing potential must have a negative serum pregnancy test performed
within 7 days prior to randomisation and must agree to use adequate contraception
prior to randomisation and for the duration of study participation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Life expectancy less than 3 months.

- Substance abuse, medical, psychological, or social condition that may interfere with
the patient's participation in the study or evaluation of the study results.

- Severe cardiac or renal disease.

- Frank hypothyroidism.

- Hyponatraemia.

- Known or suspected allergy to lithium.

- Women who are pregnant or breast-feeding.

- Inability to comply with protocol and /or not willing or not available for follow-up
assessments.

- Significant psychiatric or neurologic illness (prior known psych/cognitive/CNS
pathology eg CVA; known or prior brain metastases

- Current lithium therapy.

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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2014
Sample size
Target
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Barwon Health - Geelong
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - Moorabbin
Recruitment postcode(s) [1] 0 0
3220 - Geelong
Recruitment postcode(s) [2] 0 0
3189 - Moorabbin

Funding & Sponsors
Primary sponsor type
Other
Name
Barwon Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Deakin University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Peter MacCallum Cancer Centre, Australia
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Small cell lung cancer is an aggressive neuroendocrine tumour that often presents with
extensive (metastatic) disease. Chemotherapy is the mainstay of treatment, with radiotherapy
to the primary tumour. It is now part of care to also offer Prophylactic Cranial Irradiation
(PCI) in order to prevent spread of the cancer into the brain.

Cognitive impairment can result after cranial irradiation. Lithium is thought to be
neuroprotective. It is hypothesized that lithium administration with PCI will be safe,
tolerable and feasible, and can be studied to prevent or ameliorate the ensuing cognitive
impairment.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01486459
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mustafa Khasraw, MD
Address 0 0
Barwon Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01486459