Phase II Randomized Study on Locally Advanced NSCLC Escalated Dose on Individual Basis Treatment With Radiochemotherapy

Phase II Randomized Study on Locally Advanced Non Small Cell Lung Cancer Escalated Dose on Individual Basis Treatment With Radiochemotherapy

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01664663

Acronym

PLANET

Enrollment

Registered

2012-08-14

Start date

2011-09-30

Completion date

2015-10-31

Last updated

2014-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Disease, Non Small Cell Lung Cancer

Keywords

Radiotherapy, Dose escalation, Normal tissue constraints, Locally advanced disease, Good performance status

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.

Interventions

RADIATIONStandard radiochemotherapy to 68 Gy

RADIATIONDose escalated radiochemotherapy up to 84 Gy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Progression free survival	36 monts after randomization

Secondary

Measure	Time frame	Description
Numbers of patients without progression of locoregional disease	36 months after randomization	Measured with CT-scan according to the RECIST criteria for response

Other

Measure	Time frame	Description
Quality of life	Up to 36 months after randomization	Measured by questionaires, EORTC QLQ 30 + LC 14
Numbers of patients with adverse events	Up to 36 months after randomization	According to CTC version 4.0
Overall survival	36 months after randomization	—

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026