No registrations found.
ID
Source
Brief title
Health condition
non-small-cell lung cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint is recurrence-free survival.
Secondary outcome
Secundary end-points are overall survival, dose intensity of subsequent cycles, quality of life, toxicity, health economics. Exploratory endpoints are analysis of blood and tumor samples for prognostic markers, genomics/proteomics.
Background summary
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. A total of 864 patients will be entered in the study (432 patients in each arm) in 4 years. The follow up will continue for 5 years further, at the end of which a total of 150 events would be observed allowing the comparison (alpha=0.05 one-sided log-rank test.) of the curves by treatment arm with 80% power to test the non-inferiority of no chemotherapy to adjuvant chemotherapy.
Study objective
The primary aim of the study is to investigate whether it is possible to select patients by PET in a good prognosis group (i.e. low SUV) who will not benefit from adjuvant chemotherapy.
Study design
4 years follow-up
Intervention
Patients will be randomised to observational or will be treated with 4 cycles of one of the four cisplatin-based chemotherapy regimens:
--Docetaxel (75 mg/m2 day 1) and cisplatin (75 mg/m2 day 1) Q 3 weeks
-Gemcitabine (1250 mg/m2 day 1 and 8) and cisplatin (75 mg/m2 day 1) Q 3 weeks
-Pemetrexed (500 mg/m2 day 1) and cisplatin (75 mg/m2 day 1) Q 3 weeks
-Vinorelbine (25 mg/m2 day 1 and day 8) and cisplatin (75 mg/m2) day 1 Q 3 weeks
NVALT Trial Desk
Plesmanlaan 121
D. Storm
Amsterdam 1066 CX
The Netherlands
+31(0)20 5129111
d.storm@nki.nl
NVALT Trial Desk
Plesmanlaan 121
D. Storm
Amsterdam 1066 CX
The Netherlands
+31(0)20 5129111
d.storm@nki.nl
Inclusion criteria
1. Age >= 18 years
2. Patients with NSCLC, pT2N0, pT1N1, pT2N1, pT3N0 and pT3N1
3. SUVmax < 10
4. Patients with NSCLC who had a surgical R0 resection
5. Performance score <= 2 before CT
6. 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.
7. Patients must sign and date an approved Informed Consent form.
Exclusion criteria
1. Patients with incomplete or inadequate pulmonary resections. incomplete preoperative or intraoperative staging, wedge or segmental resection.
2. Prior chemotherapy or radical radiotherapy.
3. 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).
4. Concomitant treatment with any other experimental drug under investigation.
5. 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.
6. Pregnancy
7. Women of child-bearing potential not using effective means of contraception
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1172 |
| NTR-old | NTR1217 |
| Other | : NVALT 8A |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |