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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Lung Neoplasms

Treatments: Radiation: Intensity Modulated Radiotherapy (IMRT); Drug: DOCETAXEL; Drug: CISPLATIN

Study type: Interventional

Funder types: Industry

Identifiers

NCT01266512

DOCET_L_05158

U1111-1115-3573 (Other Identifier)

Details and patient eligibility

About

Primary Objective:

• Response rate (by contrast CT scan)

Secondary Objectives:

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

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 1 patient group

IMRT & docetaxel-cisplatin

Experimental group

Description:

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

Treatment:

Drug: CISPLATIN

Radiation: Intensity Modulated Radiotherapy (IMRT)

Drug: DOCETAXEL