Clinical trial NCT01266512: Concurrent Chemoradiotherapy Using Intensity Modulated Radiotherapy (IMRT) & Docetaxel-cisplatin (or Carboplatin) Followed by Adjuvant Chemotherapy for Inoperable Stage III Non-small-cell Lung Cancer
Official title: Phase II Study of Concurrent Chemoradiotherapy Using IMRT (With Single Photon Emission Computed Tomography/SPECT-CT to Define Functional Lung Volume and Positron Emission Tomography/PET to Define Gross Tumour Volume/GTV) and Docetaxel-cisplatin (or Carboplatin) Followed by Adjuvant Chemotherapy for Inoperable Stage III Non-small-cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lung Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-12-24
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary Objective:

* Response rate (by contrast CT scan)

Secondary Objectives:

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Response rate (by contrast CT scan)
timeFrame: 12 weeks after completion of adjuvant chemotherapy or within 4 weeks after premature study discontinuation
Secondary outcomes:
measure: Progression Free survival (PFS)
timeFrame: Day 1 of treatment to the date of objective disease progression
measure: Overall survival (OS)
timeFrame: Day 1 of treatment to the date of death due to any cause
measure: Adverse events (including oesophageal and pulmonary toxicities)
timeFrame: Informed consent signature up to 12 weeks after completion of treatment
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: