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

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

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.

Study Overview

• Status: Terminated
• Conditions: Non Small Cell Lung Cancer; Locally Advanced Disease
• Intervention / Treatment: Radiation: Standard radiochemotherapy to 68 Gy; Radiation: Dose escalated radiochemotherapy up to 84 Gy

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 Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 2

Contacts and Locations

Study Locations

• Sweden
  • Norrland
    • Umeå, Norrland, Sweden, 901 85
      • Department of Oncology, Norrlands Universitetssjukhus
  • Stockholm county
    • Stockholm, Stockholm county, Sweden, 171 76
      • Department of Oncology, Karolinska University Hospital
  • Västra Götaland
    • Gothenburg, Västra Götaland, Sweden, 413 45
      • Department of Oncology, Sahlgrenska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm A:Standard radiochemotherapy; 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.	Radiation: Standard radiochemotherapy to 68 Gy
Experimental: Arm B Escalated radiochemotherapy; 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.	Radiation: Dose escalated radiochemotherapy up to 84 Gy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression free survival	36 monts after randomization

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ass. Prof. Jan Nyman
• Investigators: Principal Investigator: Jan Nyman, Ass. prof, Swedish Lung Cancer Study Group

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): November 1, 2013
• Study Completion (Anticipated): October 1, 2015

Study Registration Dates

• First Submitted: August 10, 2012
• First Submitted That Met QC Criteria: August 10, 2012
• First Posted (Estimate): August 14, 2012

Study Record Updates

• Last Update Posted (Estimate): December 9, 2014
• Last Update Submitted That Met QC Criteria: December 8, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Radiotherapy; Dose escalation; Locally advanced disease; Normal tissue constraints; Good performance status
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: PLANET