NCT01664663

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2011

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

December 9, 2014

Status Verified

December 1, 2014

Enrollment Period

2.2 years

First QC Date

August 10, 2012

Last Update Submit

December 8, 2014

Conditions

Non Small Cell Lung CancerLocally Advanced Disease

Keywords

RadiotherapyDose escalationNormal tissue constraintsLocally advanced diseaseGood performance status

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    36 monts after randomization

Secondary Outcomes (1)

  • Numbers of patients without progression of locoregional disease

    36 months after randomization

Other Outcomes (3)

  • Overall survival

    36 months after randomization

  • Numbers of patients with adverse events

    Up to 36 months after randomization

  • Quality of life

    Up to 36 months after randomization

Study Arms (2)

Arm A:Standard radiochemotherapy

ACTIVE COMPARATOR

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

Arm B Escalated radiochemotherapy

EXPERIMENTAL

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

Interventions

Standard radiochemotherapy to 68 GyRADIATION
Arm A:Standard radiochemotherapy
Dose escalated radiochemotherapy up to 84 GyRADIATION
Arm B Escalated radiochemotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Oncology, Norrlands Universitetssjukhus

Umeå, Norrland, 901 85, Sweden

Location

Department of Oncology, Karolinska University Hospital

Stockholm, Stockholm County, 171 76, Sweden

Location

Department of Oncology, Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, 413 45, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 30032828DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jan Nyman, Ass. prof

    Swedish Lung Cancer Study Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assosiated professor Jan Nyman, Department of Oncology, Sahlgrenska University Hospital, Gotenburg , Sweden

Study Record Dates

First Submitted

August 10, 2012

First Posted

August 14, 2012

Study Start

September 1, 2011

Primary Completion

November 1, 2013

Study Completion

October 1, 2015

Last Updated

December 9, 2014

Record last verified: 2014-12

Locations

SE(3)