Clinical trial NCT01664663: Phase II Randomized Study on Locally Advanced NSCLC Escalated Dose on Individual Basis Treatment With Radiochemotherapy
Official title: Phase II Randomized Study on Locally Advanced Non Small Cell Lung Cancer Escalated Dose on Individual Basis Treatment With Radiochemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Locally Advanced Disease
Keywords: Radiotherapy
Dose escalation
Normal tissue constraints
Locally advanced disease
Good performance status
Lead sponsor: Swedish Lung Cancer Study Group
Sponsor class: NETWORK
First posted: 2012-08-14
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the valu of individually dose escalated radiotherapy compared with a standard dose of radiotherapy combined with standard concomitant chemotherapy for patients with locally advanced non small cell lung cancer (stage III) with good performance status.

Detailed description: This is an open label, multicentre phase II trial of individually escalated radiotherapy up to 84 Gy due to normal tissue dose constraints combined with standard concurrent chemotherapy (cisplatin-vinorelbine) compared to standard dose radiotherapy (68 Gy) combined with the same chemotherapy. There are restrictions due to lung function, performance status and pre-treatment weight loss. The main endpoint is progression free survival and additional endpoints are local control, overall survival, toxicity quality of life and relapse pattern.

Eligibility criteria: Inclusion Criteria:

* Histological or cytological diagnosis of NSCLC stage IIIA-B.
* Nonresectable or medically inoperable patients.
* No prior chemo- or radiotherapy for NSCLC.
* PS 0-1.
* FEV1 \> 1 l or \> 40% and CO diffusion capacity \> 40%.
* Patient compliance and geographic proximity that allow adequate follow-up.
* Adequate bone marrow reserve: WBCC \>3.0, platelets \>100, haemoglobin \> 100.
* Written informed concent.
* Effective use of contraception.

Exclusion Criteria:

* Excessive weight loss within 6 months (\> 10%).
* Supraclavicular nodes.
* Apical tumors-pancoast.
* T4 tumors with separate manifestations in different lobes.
* Evidence of active serious infections.
* Inadequate liver function.
* Inadequate kidney function.
* Pregnancy.
* Breast feeding.
* Serious concomitant systemic disorder.
* Second primary malignancy the last 5 years.

Primary outcomes:
measure: Progression free survival
timeFrame: 36 monts after randomization
Secondary outcomes:
measure: Numbers of patients without progression of locoregional disease
timeFrame: 36 months after randomization
Other outcomes:
measure: Overall survival
timeFrame: 36 months after randomization
measure: Numbers of patients with adverse events
timeFrame: Up to 36 months after randomization
measure: Quality of life
timeFrame: Up to 36 months after randomization
Locations:
city: Umeå
country: Sweden
facility: Department of Oncology, Norrlands Universitetssjukhus
state: Norrland
city: Stockholm
country: Sweden
facility: Department of Oncology, Karolinska University Hospital
state: Stockholm county
city: Gothenburg
country: Sweden
facility: Department of Oncology, Sahlgrenska University Hospital
state: Västra Götaland
Study officials:
affiliation: Swedish Lung Cancer Study Group
name: Jan Nyman, Ass. prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hallqvist A, Bergstrom S, Bjorkestrand H, Svard AM, Ekman S, Lundin E, Holmberg E, Johansson M, Friesland S, Nyman J. Dose escalation to 84 Gy with concurrent chemotherapy in stage III NSCLC appears excessively toxic: Results from a prematurely terminated randomized phase II trial. Lung Cancer. 2018 Aug;122:180-186. doi: 10.1016/j.lungcan.2018.06.020. Epub 2018 Jun 18.