Skip to main content
OpenTrials
Completed

NCT Number: 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

Primary Objective:

* Response rate (by contrast CT scan)

Secondary Objectives:

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis Administrative Office

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

docetaxel

Drug

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

intensity modulated radiotherapy (IMRT)

Radiation

2 Gy per fraction

Cisplatin

Drug

Pharmaceutical form: solution for infusion Route of administration: intravenous

Primary outcomes

  1. Response rate (by contrast CT scan)

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

Secondary outcomes

  1. Progression Free survival (PFS)

    Time frame: Day 1 of treatment to the date of objective disease progression

  2. Overall survival (OS)

    Time frame: Day 1 of treatment to the date of death due to any cause

  3. Adverse events (including oesophageal and pulmonary toxicities)

    Time frame: Informed consent signature up to 12 weeks after completion of treatment

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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)

Acronym: C-CRISP

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 24, 2010
Registry last updated
Jul 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.