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

NCT01266512 | Completed Phase 2

• 2 other identifiers: DOCET_L_05158U1111-1115-3573
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective:

• Response rate (by contrast CT scan) Secondary Objectives:
• Progression-free survival (PFS)
• Overall survival (OS)

Conditions

Lung Neoplasms

Outcome Measures

Primary Outcomes (1)

• Response rate (by contrast CT scan)

  12 weeks after completion of adjuvant chemotherapy or within 4 weeks after premature study discontinuation

Secondary Outcomes (3)

• 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

Study Arms (1)

IMRT & docetaxel-cisplatin

EXPERIMENTAL

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

Interventions

DOCETAXEL DRUG

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

IMRT & docetaxel-cisplatin

Intensity Modulated Radiotherapy (IMRT) RADIATION

2 Gy per fraction

IMRT & docetaxel-cisplatin

CISPLATIN DRUG

Pharmaceutical form: solution for infusion Route of administration: intravenous

IMRT & docetaxel-cisplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Docetaxel; Radiotherapy, Intensity-Modulated; Cisplatin

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2010
• First Posted: December 24, 2010
• Study Start: January 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: July 16, 2014

Record last verified: 2014-07

Locations

HK (1)