NL-OMON34015
Not yet recruiting
Phase 3
A randomized phase III study of adjuvant chemotherapy in patients with completely resected Non-Small-Cell Lung Cancer and low risk for recurrence: NVALT-8A - NVALT-8A
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- lungcancer
- Sponsor
- niversitair Medisch Centrum Groningen
- Enrollment
- 864
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Age \>\= 18 years
- •\- Patients with resectable NSCLC
- •\- SUVmax \< 10
- •\- Performance score \<\= 2 before chemotherapy.
- •\- Adequate organ function before administration of chemotherapy, including:
- •Adequate bone marrow reserve: ANC \>\= 1\.5 x 109/L, platelets \>\= 100 x 109/L.
- •Hepatic: bilirubin \<\= 1\.5 x ULN, AP, ALT, AST \<\= 3\.0 x ULN.
- •Renal: calculated creatinine clearance \>\= 60 ml/min based on the Cockroft and Gault formula.
- •\- Patients must sign and date a written Independent Ethics Committee approved informed consent form.
Exclusion Criteria
- •\- Patients with wedge or segmental resection.
- •\- Patients with stage IA NSCLC
- •\- Prior chemotherapy or radical radiotherapy for NSCLC.
- •\- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, severe cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease).
- •\- Concomitant treatment with any other experimental drug under investigation.
- •\- History of any active malignancy (other than NSCLC) unless treated more than 3 years with curative intent and no recurrence, except non\-melanoma skin cancer or in situ cervical cancer.
- •\- Pregnancy
- •\- Women of child\-bearing potential not using effective means of contraception
Outcomes
Primary Outcomes
Not specified
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