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

Non Small Cell Lung Cancer Clinical Trial

— PLANET  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01664663
• Other study ID #: PLANET
• Status: Terminated
• Phase: Phase 2
• First received: August 10, 2012
• Last updated: December 8, 2014
• Start date: September 2011
• Est. completion date: October 2015

Study information

• Verified date: December 2014
• Source: Swedish Lung Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: October 2015
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Locally Advanced Disease
• Non Small Cell Lung Cancer

Intervention

Radiation:
• Standard radiochemotherapy to 68 Gy

• Dose escalated radiochemotherapy up to 84 Gy

Locations

Country	Name	City	State
Sweden	Department of Oncology, Sahlgrenska University Hospital	Gothenburg	Västra Götaland
Sweden	Department of Oncology, Karolinska University Hospital	Stockholm	Stockholm county
Sweden	Department of Oncology, Norrlands Universitetssjukhus	Umeå	Norrland

Sponsors (1)

Lead Sponsor	Collaborator
Ass. Prof. Jan Nyman

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall survival		36 months after randomization	No
Other	Numbers of patients with adverse events	According to CTC version 4.0	Up to 36 months after randomization	Yes
Other	Quality of life	Measured by questionaires, EORTC QLQ 30 + LC 14	Up to 36 months after randomization	No
Primary	Progression free survival		36 monts after randomization	No
Secondary	Numbers of patients without progression of locoregional disease	Measured with CT-scan according to the RECIST criteria for response	36 months after randomization	No