MedDataX Logo

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

NCT ID: NCT01664663

Last Updated: 2014-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non Small Cell Lung Cancer Locally Advanced Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Standard radiochemotherapy to 68 Gy

Intervention Type RADIATION

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.

Group Type EXPERIMENTAL

Dose escalated radiochemotherapy up to 84 Gy

Intervention Type RADIATION

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Standard radiochemotherapy to 68 Gy

Intervention Type RADIATION

Dose escalated radiochemotherapy up to 84 Gy

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ass. Prof. Jan Nyman

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ass. Prof. Jan Nyman

Assosiated professor Jan Nyman, Department of Oncology, Sahlgrenska University Hospital, Gotenburg , Sweden

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jan Nyman, Ass. prof

Role: PRINCIPAL_INVESTIGATOR

Swedish Lung Cancer Study Group

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Oncology, Norrlands Universitetssjukhus

Umeå, Norrland, Sweden

Site Status

Department of Oncology, Karolinska University Hospital

Stockholm, Stockholm County, Sweden

Site Status

Department of Oncology, Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 30032828 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PLANET

Identifier Type: -

Identifier Source: org_study_id