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 ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Sanofi Identifier:
First received: December 23, 2010
Last updated: October 15, 2013
Last verified: October 2013

Primary Objective:

  • Response rate (by contrast CT scan)

Secondary Objectives:

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

Condition Intervention Phase
Lung Neoplasms
Radiation: Intensity Modulated Radiotherapy (IMRT)
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:

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: April 2014
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

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
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.


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

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 identifier: NCT01266512

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

No publications provided

Responsible Party: Sanofi Identifier: NCT01266512     History of Changes
Other Study ID Numbers: DOCET_L_05158, U1111-1115-3573
Study First Received: December 23, 2010
Last Updated: October 15, 2013
Health Authority: Hong Kong: Ethics Committee

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs processed this record on April 16, 2014