NCT01166191

Brief Summary

The investigators' group was the first to perform a phase II trial in patients with limited disease (stage I-III) small-cell lung carcinoma (SCLC) in which only the fluorodeoxyglucose-positron emission tomography (FDG-PET) positive lymph nodes were irradiated. In this trial, only 3% of isolated nodal failures were observed. However, all patients in that study were treated with 3D conformal radiotherapy (3DCRT). At present, IMRT techniques have become more standard in lung cancer. Because of the lower radiation dose to the lymph nodes outside of the planning target volume (PTV) with IMRT, higher incidences of isolated nodal failures may occur. In this trial, the investigators will investigate the patterns of local relapse after IMRT with concurrent chemotherapy in patients with stage I-III SCLC.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 20, 2010

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 23, 2017

Status Verified

May 1, 2017

Enrollment Period

8 years

First QC Date

July 19, 2010

Last Update Submit

May 22, 2017

Conditions

Stage I-III Small Cell Lung Cancer

Keywords

RadiotherapySCLC

Outcome Measures

Primary Outcomes (1)

  • Isolated nodal failures

    Proportion of isolated nodal failures 18 months post-radiotherapy

    18 months

Secondary Outcomes (4)

  • Progression-free survival

    18 months

  • Dyspnea (CTCAE 4.0)

    18 months

  • Dysphagia (CTCAE 4.0)

    18 months

  • Overall survival

    18 months

Study Arms (1)

SCLC

EXPERIMENTAL
Radiation: Radiotherapy

Interventions

RadiotherapyRADIATION

Radiotherapy

SCLC

Eligibility Criteria

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

You may qualify if:

  • Histological of cytological proven SCLC
  • UICC stage I-III, which are amendable for radical local treatment
  • Performance status 0-2
  • IMRT technique

You may not qualify if:

  • Not SCLC or mixed SCLC and other histologies (e.g. non-small cell carcinoma)
  • Stage IV
  • Performance status 3 or more
  • No IMRT technique

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MAASTRO clinic

Maastricht, Limburg, 6229 ET, Netherlands

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Dirk De Ruysscher, MD, PhD

    Maastro Clinic, The Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2010

First Posted

July 20, 2010

Study Start

May 1, 2009

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 23, 2017

Record last verified: 2017-05

Locations

NL(1)