NCT00945451

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiosurgery after docetaxel and cisplatin may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and the best dose of stereotactic radiosurgery when given after docetaxel, cisplatin, and radiation therapy and to see how well it works in treating patients with stage III non-small cell lung cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable lung-cancer

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

April 24, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 24, 2009

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2016

Completed
Last Updated

April 23, 2026

Status Verified

February 1, 2018

Enrollment Period

7.6 years

First QC Date

July 23, 2009

Last Update Submit

April 20, 2026

Conditions

Lung Cancer

Keywords

stage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage II non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

  • Maximum tolerated dose (phase I)

    5 years

  • Overall response rate by RECIST (phase II)

    5 years

Study Arms (1)

CyberKnife irradiation

EXPERIMENTAL
Device: CK

Interventions

CKDEVICE

Cyberknife Irradiation

CyberKnife irradiation

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer * Locally advanced disease * No metastatic disease * Unable to undergo surgery after concurrent chemoradiotherapy * Must have 1-3 tumor target masses \< 5 cm in greatest diameter and separated by ≥ 2 cm after concurrent chemoradiotherapy PATIENT CHARACTERISTICS: * WHO performance status 0-2 * Platelet count \> 100,000/mm³ * Hemoglobin \> 9 g/dL * Neutrophil \> 1.0 x 10\^9/L * FEV\_1 \> 30% of vital capacity * Vital capacity \> 25% of predicted value * DLCO \> 25% of predicted value * LVEF ≥ 35% * PT \> 80 * aPTT \> 35 sec * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after completion of study treatment * Not under guardianship * No dyspnea related to NYHA class III-IV heart failure * No indirect signs of pulmonary arterial hypertension (pulmonary arterial systolic BP \> 45 mm Hg) * No pulmonary acceleration time \< 100 ms * No contraindication to fiducial insertion * No geographical, social, or psychological conditions that would interfere with medical follow-up PRIOR CONCURRENT THERAPY: * Docetaxel and platinum-based drugs with concurrent irradiation allowed * No prior surgery or surgery after the first phase of treatment with concurrent chemoradiotherapy * No prior irradiation to lung * No concurrent participation in another study trial

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Centre Antoine Lacassagne

Nice, 06189, France

Location

Related Publications (1)

  • Doyen J, Poudenx M, Gal J, Otto J, Guerder C, Naghavi AO, Gerard A, Leysalle A, Cohen C, Padovani B, Ianessi A, Schiappa R, Chamorey E, Bondiau PY. Stereotactic ablative radiotherapy after concomitant chemoradiotherapy in non-small cell lung cancer: A TITE-CRM phase 1 trial. Radiother Oncol. 2018 May;127(2):239-245. doi: 10.1016/j.radonc.2018.03.024. Epub 2018 Apr 9.

    PMID: 29650404RESULT

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Pierre-Yves Bondiau, MD, PhD

    Centre Antoine Lacassagne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2009

First Posted

July 24, 2009

Study Start

April 24, 2009

Primary Completion

November 17, 2016

Study Completion

November 17, 2016

Last Updated

April 23, 2026

Record last verified: 2018-02

Locations

FR(1)