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NSCLC Feasibility Questionnaire

This feasibility study aims to assess interest and capacity for a clinical trial treating non-small cell lung cancer in women. The trial would involve double agent therapy. Main inclusion criteria are women with estrogen levels over 30 pg/ml, diagnosed with NSCLC, and a performance score of 0-2. Exclusion criteria prevent participation of those with small cell carcinoma or significant weight loss. The survey questions investigators about experience, available patient population, ability to recruit, and facilities to determine suitability for the trial.

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41 views

NSCLC Feasibility Questionnaire

This feasibility study aims to assess interest and capacity for a clinical trial treating non-small cell lung cancer in women. The trial would involve double agent therapy. Main inclusion criteria are women with estrogen levels over 30 pg/ml, diagnosed with NSCLC, and a performance score of 0-2. Exclusion criteria prevent participation of those with small cell carcinoma or significant weight loss. The survey questions investigators about experience, available patient population, ability to recruit, and facilities to determine suitability for the trial.

Uploaded by

zaq rew
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOC, PDF, TXT or read online on Scribd
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“PROVIDING A HELPING HAND IN CLINICAL

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


______________________________
“PROVIDING A HELPING HAND IN CLINICAL
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.

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