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RESEARCH”
C l in Tec
Feasibility study:
The main objectives of this feasibility survey are to assess investigator interest in clinical
trial participation, available patient population, site recruiting capacity and logistical
issues for the treatment of non small cell lung cancer in women with estradiol>30pg/ml.
Treatment involves double agent therapy.
Main Inclusion Criteria
1) Women with baseline estradiol >30 pg/ml
2) Histologically- or cytologically-confirmed diagnosis of NSCLC
3) ECOG performance score (PS) of 0, 1, or 2
4) 0 = fully active, able to carry on all pre-disease performance without restriction
5) 1 = restricted in physically strenuous activity but ambulatory and able to carry out
work of a light or sedentary nature, e.g., light house work, office work
6) 2 = ambulatory and capable of all self-care but unable to carry out any work
activities and up and about more than 50% of waking hours.
7) Patients must meet one of the following criteria:
• Recurrent disease following completion of radiation or surgery
• Stage IIIb who are not candidates for combined modality therapy (primary
radiation therapy or surgery), or
• Stage IV
8) Age ≥18 years
9) Life expectancy ≥12 weeks
Main Exclusion Criteria
None of the following characteristics may be present:
1) Evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell
histology.
2) Weight loss >10% in previous 6 months
3) LDH > 600 IU/l regardless of weight loss
4) Both LDH > 400 IU/l and ≥ 5% weight loss in previous 6 months
5) BMI >35
6) Any prior systemic chemotherapy for the treatment of lung cancer. this includes
systemic radiosensitizers used to treat brain metastases and any biologic agent.
7) Local palliative radiotherapy < 7 days before randomization.
8) Radiation with curative intent < 30 days before randomization.
9) Concurrent primary malignancies except for carcinoma in situ or non-melanoma
skin cancer.
10) Grade 2 or greater neuropathy.
“PROVIDING A HELPING HAND IN CLINICAL
RESEARCH”
C l in Tec
Thank you very much for taking this survey – we sincerely appreciate
your time and effort in completing this form.
It would be of great help if you could complete this survey form and return by fax or
email to:
xyz, ClinTec international ltd,
Fax no: email:
by: ________
Investigator name
Designation
Address
tel/fax :
mobile :
email :
1. Would you be interested in participating in this yes no
study?
2. If you are not interested please indicate reason.
competing study patient population
standard of care other
__________________
3a. ICH-GCP compliance
How many years have you been doing ICH-GCP _______________________________
sponsor trials?
In which therapeutic areas?
____________________________
3b. ICH-GCP compliance
______________________________
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RESEARCH”
C l in Tec
How many oncology chemotherapy trials have
you done?
_________________________________
How many of these were in NSCLC?
(PS = 2)
4a. Study Recruitment
Approximately How Many female NSCLC patients with recurrent disease 0 1-4
following XRT or surgery or with stage IIIb/IV, have you seen in the last
12 months? 5-8 >9
4b. Study Recruitment
Of these female patients, how many do you estimate are “estrogen 0 1-4
positive” (i.e. have estrogen levels >30 pg/ml either due to their pre-
menopausal status or because they take hormone replacement therapy)? 5-8 >9
4c. Study Recruitment
Which therapy (single or double agent) do you prefer for treating ps 2 single agent therapy
patients?
double agent therapy
4d. Study Recruitment
Are you currently participating in a trial, or will you be participating in a yes no
trial over the next 12 months, that competes for either of these patient
populations?
4e. Study Recruitment
Does your site have adequate staff, facilities, and other resources to yes no
conduct the proposed type of clinical trial?
4f. Study Recruitment (PS = 2)
Please specify approximately how many
patients you would be able to recruit per 0 1-4
month for the proposed clinical trials?
5-8 >9
5. Ethics Committee Details
5a. Does your site have an ethics committee? yes no
5b. How often does your IEC meet? Specify periodicity in weeks. yes no
5c. How many days does the IEC take to approve a clinical trial from the yes no
date of meeting?
“PROVIDING A HELPING HAND IN CLINICAL
RESEARCH”
C l in Tec
5d. Is the EC member composition as per ICH GCP? yes no
6. Electronic Data Capture Capabilities
Does your site have access to a high speed (cable orDSL, not dial-up) yes no
internet line?
7. Contact Information
best contact method: email fax
phone
______________________________________________
study coordinator name: best contact method: email fax
____________________ phone
______________________________________________
PLEASE COMPLETE THIS QUESTIONNAIRE AND FAX TO ____________________ BY DATE HERE.
