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)

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)

Primary Objective:

• Response rate (by contrast CT scan)

Secondary Objectives:

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

Study Overview

• Status: Completed
• Conditions: Lung Neoplasms
• Intervention / Treatment: Drug: DOCETAXEL; Radiation: Intensity Modulated Radiotherapy (IMRT); Drug: CISPLATIN

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 2

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Drug: DOCETAXEL; Pharmaceutical form: docetaxel 20mg or 80 mg concentrate for solution for infusion Route of administration: intravenous; Radiation: Intensity Modulated Radiotherapy (IMRT); 2 Gy per fraction; Drug: CISPLATIN; Pharmaceutical form: solution for infusion Route of administration: intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response rate (by contrast CT scan)	12 weeks after completion of adjuvant chemotherapy or within 4 weeks after premature study discontinuation

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression Free survival (PFS)	Day 1 of treatment to the date of objective disease progression
Overall survival (OS)	Day 1 of treatment to the date of death due to any cause
Adverse events (including oesophageal and pulmonary toxicities)	Informed consent signature up to 12 weeks after completion of treatment

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: December 23, 2010
• First Submitted That Met QC Criteria: December 23, 2010
• First Posted (Estimate): December 24, 2010

Study Record Updates

• Last Update Posted (Estimate): July 16, 2014
• Last Update Submitted That Met QC Criteria: July 15, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: DOCET_L_05158; U1111-1115-3573 (Other Identifier: UTN)