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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)

This study is currently recruiting participants.
Verified December 2012 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01266512
First received: December 23, 2010
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

Primary Objective:

  • Response rate (by contrast CT scan)

Secondary Objectives:

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

Condition Intervention Phase
Lung Neoplasms
 Drug: DOCETAXEL
Radiation: Intensity Modulated Radiotherapy (IMRT)
Drug: CISPLATIN
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Response rate (by contrast CT scan) [ Time Frame: 12 weeks after completion of adjuvant chemotherapy or within 4 weeks after premature study discontinuation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free survival (PFS) [ Time Frame: Day 1 of treatment to the date of objective disease progression ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: Day 1 of treatment to the date of death due to any cause ] [ Designated as safety issue: No ]
  • Adverse events (including oesophageal and pulmonary toxicities) [ Time Frame: Informed consent signature up to 12 weeks after completion of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 43
Study Start Date: December 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01266512

Contacts
Contact: Trial Transparency Team Contact-us@sanofi.com

Locations
Hong Kong
Sanofi-Aventis Administrative Office Recruiting
Hong Kong, Hong Kong
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01266512     History of Changes
Other Study ID Numbers: DOCET_L_05158, U1111-1115-3573
Study First Received: December 23, 2010
Last Updated: December 19, 2012
Health Authority: Hong Kong: Ethics Committee

Additional relevant MeSH terms:
Neoplasms
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
 Adjuvants, Immunologic
Docetaxel
Cisplatin
Carboplatin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 16, 2013