Outline proposal for clinical trial protocols to be submitted to the EORTC Protocol Review Committee.

 

Person filling this form

Name
Institution number
Modified by
Final version yes No  
1

What is the title of the study?

Protocol number (if already allocated):

2

Classification according to the EORTC Scientific Strategy

Read the EORTC Scientific Stratedy implementation document for more information

Clinical trial category

1A Randomized phase III (new standards of care)
1B Randomized phase III or II/III(strong targeted TR)
2A Intergroup type 1A or 1B (EORTC not leading)
2B Phase I and Phase II (novel mechanism of action + vertical develop. with EORTC)
3A Randomized phase III or II/III (not type 1 or 2)
3B Phase I and Phase II (novel mechanism of action but no development plan with EORTC)
3C Phase I and Phase II (not type 2 or 3B)
4 Not a clinical trial(4)

Tissue stored for future research New methodology in clin. research

3

Which Group(s) will participate ?

If this is an Intergroup study, indicate the coordinating group

EORTC Group(s)
Other Group(s)

Regulatory process already started
or study already recruiting

 
Date of activation
Number of patients already included
4

Who is the study coordinator ?

For an Intergroup study, EORTC study coordinator

Name
e-mail
EORTC Group affiliation

Study coordinator of the coordinating group (it outside of the EORTC)

Name
e-mail
Group affiliation
5

Has this outline been developed with the EORTC Data Center ?

Contact person

6

What is the main objective of the trial

Question intended to be answered by the study 
7

What is the proposed trial design ?

(To be discussed with the statistician)

Please take attention to the following Phase II trial design definitions:

  • Early Phase II trials = a single arm Phase II trial of a single agent, or a randomized Phase II trial where none of the investigated regimens are standard ("screening Phase II studies")
  • Late Phase II trials = Phase II trials of combination therapies ("feasibility studies") or a randomized Phase II trial where one of the treatments is a standard treatment.

If other, specify here the name (type) and go to question 16.7 for the full description of the design
8

What is the rationale for performing this trial ?

Include a short summary of results and conclusions from previous trials, or from a systematic review as appropriate.

 
9

For trials with investigational agents: Please complete the 3 following boxes

Name (generic, code)
 Origin (ownership)
type of compound (mechanism of action/biochemical entity)
10

Further plans?

Phase III trials: How do you expect the results of this trial to affect clinical practice ?
Phase I and II trials: If the proposed trial is positive, which further studies/development strategy do you plan with the investigated drug / therapeutic policy ?
11

What are the characteristics of the population under study ?

Principal eligibility criteria
12

What are the planned trial interventions

describe all protocol treatments for each therapeutic arm (type of surgery, radiotherapy and chemotherapy dose and schedule); clearly identify the standard (control) therapeutic arm for randomized trials. "
13

What are the investigations that differ from the usual medical practice for this disease ?

14

What are the endpoints (outcome measures) ?

(to discuss with statistician)

Primary
Secondary
15

Is the study randomized ?

(to discuss with statistician)

YES timing of randomization:
NO For late phase II and phase III, justify if not randomized

16

What are the parameters of the statistical design ?

(to be completed by the statistician)
Please, complete one of the following sections
If the proposed design is not standard, complete section 16.7
  16.1 Phase I single agent
Starting dose
Dose escalation scheme
Other, specify
Number of patients per dose level
MTD definition
  16.2 Phase I combinations
Starting dose
Dose escalation scheme
Other, specify
Number of patients per dose level
MTD definition
  16.3 Early Phase II
Design
If other, specify
  P0 P1 Alpha Beta
Total nr patients (all steps)
Nr of critical events / Nr patients Step1 Step2
  16.4 Late Phase II
Design 
(based on the principal end-point):

Alpha Beta
acceptable/unacceptable levels
Nr patients (all steps)
Decision rule to
proceed to phase III:
  16.5 Phase III difference
Parameter
Estimate in the control group ?
Difference to be detected ?
Hazard ratio ?
Size of the type I and type II errors ? Alpha Beta
Total Nr patients / Nr eventsrequired ? patients events
Expected duration of recruitment  ?  
Expected duration of follow-up
after end of accrual ?		  
  16.6 Phase III non inferiority / equivalence
Parameter
Estimate in the control group ?
Maximum acceptable difference ?
Hazard ratio ?
Size of the type I and type II errors ? Alpha Beta
Nr events / patients required ? events patients
Expected duration of recruitment ?
Expected duration of follow-up
after end of accrual ?
  16.7

Stratification factors - Other statistical design

Including 2*2 factorial designs
17

Is there an early stopping rule ?

(for phase III trials) Describe eventual interim analyses and stopping rule
18

Will this trial be monitored by an IDMC ?

yes If this is not EORTC IDMC, justify
no  
19

Do you have any intention to undertake pharmacokinetic studies ?

yes Endpoints considered and sampling schedule
no Justify
20

Do you have any intention to undertake translational research studies ?

yes

What is the objective/endpoints of the study?

What type of material are you planning to use
(frozen tissue; parafin blocks; slides; blood samples, other)?

Have you already identified a laboratory to do this project?

yes no

Have you contacted a group of the EORTC Laboratory Research Division

yes no


no Justify
21

Do you intend to perform a quality of life study ?

yes Have you contacted the quality of life study group (liaison person) ? yes no
What is the rationale for including QOL in the study ?

Which QL instrument will be used ?
no  
22

Participating centers

Number of centers Expected yearly accrual

List of participating center sorted by country.
(Investigator name , center name , expected yearly accual, group affiliation)

23

Additional comments (if any)

24

External reviewers

Could you please suggest two names of experts who could be appropriate external reviewers for the present study ? 
Those experts should not be involved in the development of this protocol, and should not be potential participants.


Can this outline be circulated to external reviewers ? (to be answered by the data center team)

If no, justify