EUCTR2007-002644-21-NL
Active, not recruiting
Not Applicable
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
MCG0 sitesJuly 6, 2009
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- This is a randomized multicenter phase III study. Patient with a low SUV of the primary tumor prior to surgery will be randomised to four cycles of cisplatin-based chemotherapy or observation in a non-inferiority design.
- Sponsor
- MCG
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Age \= 18 years
- •\-Patients with NSCLC, pT2N0, pT1N1, pT2N1, pT3N0 and pT3N1
- •\-SUVmax \< 7
- •\-Patients with NSCLC who had a surgical R0 resection.
- •\-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 incomplete or inadequate pulmonary resections. incomplete preoperative or intraoperative staging, wedge or segmental resection.
- •\-Prior chemotherapy or radical radiotherapy.
- •\-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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