Status:
COMPLETED
Study of Patient Preference for Oral or Intravenous Vinorelbine in the Treatment of Advanced NSCLC
Lead Sponsor:
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Conditions:
Non-small Cell Lung Cancer Metastatic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Title: Randomized cross-over study of patient preference for oral or intravenous vinorelbine in the treatment of advanced NSCLC. A phase IV study. ShortTitle/ Acronym: VIVOS Protocol Code :IRST162.0...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed stage IIIB or IV NSCLC.
- Age ≥ 70 and Eastern Cooperative Oncology Group (ECOG) Performance status ≤2 or age ≤ 70 but ECOG PS ≥ 2
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques or as \>10 mm with spiral CT scan. See section 9.2 and Appendix E for the evaluation of measurable disease.
- Patients with asymptomatic brain metastases are eligible
- Patients with recurrent disease after previous surgery are eligible
- Life expectancy \> 3 months
- Patients must have normal organ and marrow function
- Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
- Ability to understand and the willingness to sign a written informed consent document
Exclusion
- The participant may not enter the study if ANY of the following apply:
- Patients who have had previous chemotherapy for lung cancer or radiotherapy on target lesions.
- Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
- Presence of infection.
- Preexisting clinically significant peripheral neuropathy.
- History or evidence of malabsorption syndrome or disease that may significantly affect gastrointestinal function.
- Patients with known symptomatic uncontrolled brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to vinorelbine or other agents used in the study.
- Presence of medical problems of sufficient severity to prevent full compliance with the study.
- Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 5 years (except for previously treated basal cell carcinoma and in situ carcinoma of the uterine cervix);
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2018
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01848613
Start Date
October 1 2012
End Date
May 1 2018
Last Update
November 9 2018
Active Locations (8)
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1
Irccs Irst
Meldola (FC), FC, Italy, 47014
2
U.O. Oncologia Ospedale Civile degli Infermi
Faenza, RA, Italy, 48018
3
U.O. Oncologia Ospedale Civile Umberto I
Lugo, RA, Italy, 48022
4
UO Oncologia Medica, Ospedale S.Maria delle Croci
Ravenna, RA, Italy, 48121