PART 1: STUDY INFORMATION
STUDY TITLE AND NUMBER Outline form
Modified by
Study Title Recommended format: "Question, patient population: type of study, EORTC **** Group (+other Groups) Example

Bruxellomycin monotherapy versus standard supportive care for refractory or recurrent advanced stage cutaneous T-cell lymphoma: a randomized phase III of the EORTC Cutaneous T-Cell Lymphoma Task Force and the Southwest Oncology Group
Study number - (both group's numbers if 2 EORTC groups involved)
Final version for PRC submission when "yes" saving will submit to PRC
Short title/ Study acronym  
max. 50 characters, to be used in communication and full protocol header
STUDY COORDINATOR Outline form
Study coordinator 1  Name
 Email
 Institution name
   Institution number
   Group affiliation
Study coordinator 2  Name
   Email
   Institution name
   Institution number
   Group affiliation
Study coordinator 3  Name
   Email
   Institution name
   Institution number
   Group affiliation
PARTICIPATING GROUPS Outline form
Other EORTC group involved  if yes indicate group name
Non-EORTC Collaborative group(s) involved  if yes indicate the name(s)
Is the non-EORTC group leading  
  if yes, indicate details of study coordinator of the leading group
name
email
  has intergroup study already started?
  if yes, specify number of patients already included
EXTERNAL REVIEWERS Outline form
  Suggest three experts who would be appropriate external reviewers for this study? These experts should not be involved in the development of this protocol, and should not be potential participants.

 

Indicate if this outline can not be circulated to external reviewers ? (to be answered by the headquarters team)

 

Note: A one page study scheme can be submitted to prc [at] eortc.be and will be circulated to reviewers with outline
EORTC CLASSIFICATION Outline form
Clinical trial category  

tissue stored for future research  new methodology in clinical research  

 
PART 2: PROJECT DESCRIPTION AND RATIONALE
STUDY RATIONALE Outline form
  help
What is the current standard of care for the patient population EU
 
  US
How will this study address a therapeutic need
Given that need, why was this specific compound / treatment chosen Mechanism, scientific rationale
Explain choice of dose and give reference
What preclinical evidence supports the choice
What clinical data supports the choice (same and/or different indication)
Reference for reference value of design
 
PART 3 : TRIAL DESIGN
PATIENT POPULATION Outline form
Patient population indicate relevant patient characteristics
TRIAL OBJECTIVES Outline form
What is the main objective of the trial

 
TRIAL DESIGN Outline form
Trial design
Is the study randomized

 

if yes, indicate the timing of randomization

 

 

give stratification factors

 

 
Describe treatment group(s)

or dose levels for phase I
 
Primary endpoint(s) also specify the parameter used in the statistical design - help

e.g. OS, we will use OS at 5 years or definition of DLT for Phase I

 
Secondary endpoint(s)  
STATISTICAL DESIGN FOR PRIMARY ENDPOINT Outline form
Phase I single agent
starting dose  
dose escalation scheme
number of patients per dose level
Phase I combination
starting dose and description of dose levels
number of patients per dose level
Phase II
design
if other, specify
null hypothesis  
alternative hypothesis as used for the power calculation  
total number patients (all steps)
type I and type II errors Alpha  Beta
critical number of successes necessary to continue/reject null hypothesis stage1  successes help /  patients help ,
total  successes help /  patients help

The minimum number of successes in order
to proceed to Stage 2 of the trial

Minimum number of patients required
to be accrued to conduct Stage 1 of the trial

The minimum number of successes to indicate
that the treatment is effective

Minimum number of patients required to be accrued
to conduct the trial
if not classical Simon, specify decision rule at each stage of the design
Phase III superiority
null hypothesis including estimate for control group  
alternative hypothesis as used for the power calculation  
type I and type II errors Alpha  Beta  sides
number of events/ patients  events  patients
expected duration of recruitment    
expected duration of follow-up
after end of accrual 		   
Phase III non inferiority / equivalence
null hypothesis including estimate for control group and delta of inferiority or equivalence  
alternative hypothesis as used for the power calculation  
type I and type II errors Alpha  Beta  sides
number of events / patients  events  patients
expected duration of recruitment  
expected duration of follow-up after end of accrual  
Statistical design other than those listed above including 2x2 factorial designs

 
Further details of statistical design Outline form
Further details of statistical design  
Is there an early stopping rule
or interim analysis planned
Describe eventual interim analysis and/or stopping rule  
Will this trial be monitored by an IDMC
  If non-EORTC IDMC, justify
 
COMPOUNDS/TREATMENTS UNDER STUDY Outline form
Number of experimental compounds/ treatments involved  help
Details name
 classification, mechanism of action
  developer
  
Details name
 classification, mechanism of action
  developer
  
Details name
 classification, mechanism of action
  developer
  
Details name
 classification, mechanism of action
  developer
  
Is surgery a protocol treatment
Is radiotherapy a protocol treatment
Do you intend to perform a quality of life study

 

if yes, what is the rationale to include Quality of Life in the study
 
which Quality of Life instrument will be used
 
have you contacted the Quality of Life Department (qol [ at ] eortc.be)  
SAFETY Outline form
Any specific safety issues  
if yes, comment
 
 
PART 4: TRANSLATIONAL RESEARCH AND BIOBANKING
4.1 Biomarker / translational research /pk /pd
Correlative study 1 Outline form
Purpose if the TR/biobanking
for "Prospective sample collection": fill 4.2 only
Correlative study title
Correlative study background
What is the relevance for cancer/rationale for the relation with treatment decision? What is the potential clinical impact
What is (are) the main objective(s) of the correlative study Primary aim, secondary aim, tertiary aim
Sample Size considerations
Please refer to guidelines for help completing these field
Specimen Time points Storage conditions Type of assay / platform Biomarker Mandatory Collection y/n % Specimen availability
Are the assays validated; will centralized testing be used? Please give any preliminary sensitivity, specificity and precision measurements
Has the TRD been contacted?
Name of laboratory and responsible person foreseen to perform TR
Name of the statistician
NB EORTC statisticians perform analysis pertaining to the relationship of the biomarker and clinical outcome. Unsupervised analysis will not be performed in EORTC HQ
Correlative study financial support
(e.g. collection, samples processing, storage, shipment, testings/technique, analysis/reporting)
Correlative study 2 Outline form
Purpose if the TR/biobanking
for "Prospective sample collection": fill 3.2 only
Correlative study title
Correlative study background
What is the relevance for cancer/rationale for the relation with treatment decision? What is the potential clinical impact
What is (are) the main objective(s) of the  correlative study Primary aim, secondary aim, tertiary aim
Sample Size considerations
Please refer to guidelines for help completing these field
Specimen Time points Storage conditions Type of assay / platform Biomarker Mandatory Collection y/n % Specimen availability
Are the assays validated; will centralized testing be used? Please give any preliminary sensitivity, specificity and precision measurements
Has the TRD been contacted?
Name of laboratory and responsible person foreseen to perform TR
Name of the statistician
NB EORTC statisticians perform analysis pertaining to the relationship of the biomarker and clinical outcome. Unsupervised analysis will not be performed in EORTC HQ
Correlative study financial support
(e.g. collection, samples processing, storage, shipment, testings/technique, analysis/reporting)
   
Correlative study 3 Outline form
Purpose if the TR/biobanking
for "Prospective sample collection": fill 3.2 only
Correlative study title
Correlative study background
What is the relevance for cancer/rationale for the relation with treatment decision? What is the potential clinical impact
What is (are) the main objective(s) of the correlative study Primary aim, secondary aim, tertiary aim
Sample Size considerations
Please refer to guidelines for help completing these field
Specimen Time points Storage conditions Type of assay / platform Biomarker Mandatory Collection y/n % Specimen availability
Are the assays validated; will centralized testing be used? Please give any preliminary sensitivity, specificity and precision measurements
Has the TRD been contacted?
Name of laboratory and responsible person foreseen to perform TR
Name of the statistician
NB EORTC statisticians perform analysis pertaining to the relationship of the biomarker and clinical outcome. Unsupervised analysis will not be performed in EORTC HQ
Correlative study financial support
(e.g. collection, samples processing, storage, shipment, testings/technique, analysis/reporting)
Correlative study 4 Outline form
Purpose if the TR/biobanking
for "Prospective sample collection": fill 3.2 only
Correlative study title
Correlative study background
What is the relevance for cancer/rationale for the relation with treatment decision? What is the potential clinical impact
What is (are) the main objective(s) of the correlative study Primary aim, secondary aim, tertiary aim
Sample Size considerations
Please refer to guidelines for help completing these field
Specimen Time points Storage conditions Type of assay / platform Biomarker Mandatory Collection y/n % Specimen availability
Are the assays validated; will centralized testing be used? Please give any preliminary sensitivity, specificity and precision measurements
Has the TRD been contacted?
Name of laboratory and responsible person foreseen to perform TR
Name of the statistician
NB EORTC statisticians perform analysis pertaining to the relationship of the biomarker and clinical outcome. Unsupervised analysis will not be performed in EORTC HQ
Correlative study financial support
(e.g. collection, samples processing, storage, shipment, testings/technique, analysis/reporting)
4.2 prospective sample collection only
Please refer to guidelines for help completing these field
Type of specimen Time points Storage conditions Mandatory Collection y/n % Specimen availability
Justification and use of prospective collection of material. Please give future TR hypothesis.
Primary aim: New field – BioUseS1 Secondary aim
Justify number of samples needed
Financial support
Please specify which costs are secured and by who
(e.g. collection, sample processing, storage, shipment)