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

Phase 2

Terminated

• Conditions: Locally Advanced Disease; Non Small Cell Lung Cancer
• Interventions: Radiation: Dose escalated radiochemotherapy up to 84 Gy; Radiation: Standard radiochemotherapy to 68 Gy

• Registration Number: NCT01664663
• Lead Sponsor: Ass. Prof. Jan Nyman

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.

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-08-10
• Study First Submitted QC: 2012-08-10
• Study First Posted: 2012-08-14
• Primary Completion: 2013-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-08
• Last Update Posted: 2014-12-09
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 37

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B Escalated radiochemotherapy	Dose escalated radiochemotherapy up to 84 Gy	Radiotherapy with 2 Gy per fraction 5 or 6 times a week to 68-84 Gy to the planning target volume due to normal tissue tolerance constraints. Dose to lung tissue, esophagus and spinal cord will be considered. Three courses of cisplatin 75 mg/m2 day 1 and vinorelbine 25 mg/m2 day 1+8 will be given, two courses concomitant with radiation.
Arm A:Standard radiochemotherapy	Standard radiochemotherapy to 68 Gy	Radiotherapy with 2 Gy per fractions 5 fractions a week to 68 Gy to the planning target volume. Three courses of cisplatin 75 mg/m2 day 1and vinorelbine 25 mg/m2 day 1+8. Two courses concomitant with radiation.

Primary Outcome Measures

Name	Time	Method
Progression free survival	36 monts after randomization

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Department of Oncology, Norrlands Universitetssjukhus; 🇸🇪 Umeå, Norrland, Sweden

Department of Oncology, Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Västra Götaland, Sweden

Department of Oncology, Karolinska University Hospital; 🇸🇪 Stockholm, Stockholm county, Sweden