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WithdrawnNCT00210171BIB 01Updated Sep 10, 2025

Concomitant Chemo-radiotherapy in Locally Advanced Non Small Cell Lung Cancer

A Phase 2 interventional study of Toxicity : Time to progression, 1 and 2 years survival in Carcinoma, Non-Small-Cell Lung, sponsored by Institut Bergonié. Withdrawn at 7 sites in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-09-10.

Sponsored by Institut Bergonié · Phase 2, Interventional, and Treatment

Why this study was withdrawn
The study was withdrawn due to logistic issues.

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled May 2004, registered Sep 2005).
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Feasibility of pragmatic concomitant chemo-radiotherapy association with 1 cycle of Induction chemotherapy, weekly chemo-radiotherapy, and consolidation chemotherapy.

02

Conditions studied

  • Carcinoma, Non-Small-Cell Lung

Keywords

  • Carcinoma
  • Stage IIIA Non Small Cell Lung
  • Stage IIIB Non-Small-Cell Lung
  • Concomitant chemo-radiotherapy
  • Consolidation chemotherapy
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Institut Bergonié is the lead sponsor of 119 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Histologically or cytologically confirmed newly diagnosed, untreated, unresectable stage IIIA or stage IIIB non-small cell lung cancer Not scheduled for curative cancer surgery No pleural effusion At least 1 bidimensionally or unidimensionally measurable lesion Age 18 years et 70 years; Performance Status \< 2 Loss of weight \< 10 % in past 6 months life expectancy 12 weeks; Bilirubin normal ASAT (SGOT) et ALAT (SGPT) 1,5 times upper limit of normal; Alcalin phosphatases 5 times upper limit of normal; Créatinin 1,5 x times upper limit of normal; Absolute neutrophil count greater than 2.109/l; Platelet count greater than 100.109/l; Hémoglobin ³ 10 g/ dl; Respiratory function : FEV1>50% write Consent

Exclusion criteria

Exclusion criteria:

Pregnant or nursing; Fertile patients who don't used effective contraception; No other malignancy within past 5 years except inactive carcinoma in situ of the cervix or nonmelanoma skin cancer ; Neuropathy grade NCI-CTC 2; Past thoracic radiotherapy; Past chemotherapy, immunotherapy or biologic therapy for non small cell lung cancer ; Respiratory deficiency FEV1 \< 45% ; Hypersensibility to docetaxel or cisplatin; At least 4 weeks since other concurrent investigational agents;

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Enrollment
0 participants (actual)

Interventions

  • ProcedureToxicity : Time to progression, 1 and 2 years survival
06

What researchers measure

Primary outcomes

  1. Objective response

    Time frame: 6 months

07

Study locations

7 sites
  • Centre de radiothérapie d'Agen
    Agen, 47000, France
  • Clinique Tivoli
    Bordeaux, 33000, France
  • Polyclinique Bordeaux Nord
    Bordeaux, 33000, France
  • Centre Hospitalier Universitaire de Bordeaux
    Bordeaux, 33076, France
  • Institut Bergonié - Centre Régional de Luttre Contre le Cancer de Bordeaux et du Sud Ouest
    Bordeaux, 33076, France
  • Hôpital Robert Boulin
    Libourne, 33500, France
  • Clinique Francheville
    Périgueux, 24000, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00210171
Lead sponsor
Institut Bergonié
Collaborators
Sanofi
Responsible party
Sponsor
First posted
Sep 21, 2005
Start date
May 2004
Primary completion
May 2004
Completion
May 2004
Last update
Sep 10, 2025

Study contacts

François CHOMY, MD
principal investigator · Institut Bergonié

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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