Concurrent Chemoradiotherapy Using Intensity Modulated Radiotherapy (IMRT) & Docetaxel-cisplatin (or Carboplatin) Followed by Adjuvant Chemotherapy for Inoperable Stage III Non-small-cell Lung Cancer

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2014-03-31

Brief Summary

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Primary Objective:

* Response rate (by contrast CT scan)

Secondary Objectives:

* Progression-free survival (PFS)
* Overall survival (OS)

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Detailed Description

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The duration of the study for each patient will include an up to 6-week screening phase, 12 weeks treatment phase (including a resting period of 2 weeks) followed by a long-term follow-up.

Conditions

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Lung Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IMRT & docetaxel-cisplatin

Concurrent chemo-RT:

Radiotherapy: IMRT - Docetaxel 20mg/m2 + cisplatin 20mg/m2 weekly for 6 weeks -

Resting period: 2 weeks -

Adjuvant chemotherapy: Q3W for 2 cycles Docetaxel 35 mg/m² IV infusion for 1 hour on D1\&8 - Cisplatin 35 mg/m² on D1\&8 -

Dexamethasone for a total of 3 doses is to be given at a dose of 4 mg at 12 hours, 1 hour before and 12 hours after docetaxel administration

Group Type EXPERIMENTAL

DOCETAXEL

Intervention Type DRUG

Pharmaceutical form: docetaxel 20mg or 80 mg concentrate for solution for infusion Route of administration: intravenous

Intensity Modulated Radiotherapy (IMRT)

Intervention Type RADIATION

2 Gy per fraction

CISPLATIN

Intervention Type DRUG

Pharmaceutical form: solution for infusion Route of administration: intravenous

Interventions

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DOCETAXEL

Pharmaceutical form: docetaxel 20mg or 80 mg concentrate for solution for infusion Route of administration: intravenous

Intervention Type DRUG

Intensity Modulated Radiotherapy (IMRT)

2 Gy per fraction

Intervention Type RADIATION

CISPLATIN

Pharmaceutical form: solution for infusion Route of administration: intravenous

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pathologically proven locally advanced, inoperable, confirmed by PET scan (thorax/ upper abdomen) to be International stage III (2009) NSCLC and without multifocal tumours in the lung
* Disease volume encompassible within a tolerable Planning Target Volume treated to 66 Gy
* FEV1 (Force Expiratory Volume in 1 Second) \>1000 ml
* Hemoglobin ≥ 9.0 g/dl
* Absolute neutrophil count (ANC) ≥ 1,500/mm3
* Platelet count ≥ 100,000/mm3
* Total bilirubin ≥ 1.5 times the upper limit of normal
* ALT (Alanine Aminotransferase) and AST (Aspartate transaminase) ≤ 2.5 x upper limit of normal (≤ 5 x upper limit of normal for patients with liver derangement)
* ECOG (Eastern Cooperative Oncology Group) PS 0-1

Exclusion Criteria

* Previous treatment with chest radiotherapy, chemotherapy or molecularly targeted agents
* Inadequate lung function (Exercise tolerance less than 1 FOS/Fight of stairs, FEV1 \< 1 L/sec, or raised pCO2)
* History of hypersensitivity or contraindication to the study drugs or pre-medications or products formulated in polysorbate 80
* Pregnant or breast-feeding women, or women with child-bearing potential who are not following an effective method of contraception and/or who are unwilling or unable to be tested for pregnancy (either by serum or urine pregnancy test before study entry
* Participation in a clinical trial with any investigational drug used and within 30 days prior to study entry

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No