Clinical trial · Interventional
UFUR (Tegafur/Uracil) Plus Iressa in Non-small-cell Lung Cancer
Phase II Trial of Adding UFUR to Non-small-cell Lung Cancer Patients Treated With Iressa
NCT01037998CI-TRIAL-00002928completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Iressa \[epidermal growth factor tyrosine kinase inhibitor (EGFR-TKI)\] has been reported to activity against Non-small-cell Lung Cancer (NSCLC) failed previous chemotherapy. UFUR was found to have anti-angiogenesis effect when long term treatment was given. Combination of EGFR-TKI and anti-angiogenesis agents is a novel treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small-Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| UFUR and Iressa | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- Iressa 250 mg daily treatment plus UFUR twice daily treatment
- interventionNames
- Drug: UFUR and Iressa
- type
- NO_INTERVENTION
- label
- B
- description
- Gefitinib 250 mg daily treatment
Primary outcomes (1)
- measure
- To assess and compared the 6-month survival rate of these two arms of treatment.
- timeFrame
- 6 months
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologic or cytological diagnosis of NSCLC who failed previous platinum-based and taxanes chemotherapy. * No prior radiotherapy on measurable lesion(s). * Performance status of 0 to 3 on the Zubrod scale. (Reference 1) * Clinically measurable disease, defined as bidimensionally measurable lesions with clearly defined margins on x-ray, scan, or physical examination. Lesions serving as measurable disease must be at least 1 cm by 1 cm, as defined by CT scan, MRI, or chest x-ray. * Informed consent from patient. * Males or females 18 years of age or older. * If female: childbearing potential either terminated by surgery, radiation, or menopause, or attenuated by use of an approved contraceptive method (intrauterine contraceptive device \[IUD\], birth control pills, or barrier device) during and for three months after trial. Exclusion Criteria: * Active infection (at the discretion of the investigator). * Inadequate liver function (total bilirubin \>1.5 times above normal range); alanine transaminase (ALT) and aspartate transaminase (AST) greater than 5 times normal. * Inadequate renal function (creatinine \>2.0 mg/dL). * Breast feeding. * Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin) * Concomitant myelosuppressive radiotherapy, chemotherapy, hormonal therapy, or immunotherapy will not be allowed except as for palliative radiation to non-measurable lesion.
References
Publications (0)
Data not yet available
No reference posted for this study.