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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)

Primary Purpose

Lung Neoplasms

Status
Completed
Phase
Phase 2
Locations
Hong Kong
Study Type
Interventional
Intervention
DOCETAXEL
Intensity Modulated Radiotherapy (IMRT)
CISPLATIN
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IMRT & docetaxel-cisplatin

Arm Description

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

Outcomes

Primary Outcome Measures

Response rate (by contrast CT scan)

Secondary Outcome Measures

Progression Free survival (PFS)
Overall survival (OS)
Adverse events (including oesophageal and pulmonary toxicities)

Full Information

First Posted
December 23, 2010
Last Updated
July 15, 2014
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01266512
Brief Title
Concurrent Chemoradiotherapy Using Intensity Modulated Radiotherapy (IMRT) & Docetaxel-cisplatin (or Carboplatin) Followed by Adjuvant Chemotherapy for Inoperable Stage III Non-small-cell Lung Cancer
Acronym
C-CRISP
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

5. Study Description

Brief Summary
Primary Objective: Response rate (by contrast CT scan) Secondary Objectives: Progression-free survival (PFS) Overall survival (OS)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMRT & docetaxel-cisplatin
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
DOCETAXEL
Intervention Description
Pharmaceutical form: docetaxel 20mg or 80 mg concentrate for solution for infusion Route of administration: intravenous
Intervention Type
Radiation
Intervention Name(s)
Intensity Modulated Radiotherapy (IMRT)
Intervention Description
2 Gy per fraction
Intervention Type
Drug
Intervention Name(s)
CISPLATIN
Intervention Description
Pharmaceutical form: solution for infusion Route of administration: intravenous
Primary Outcome Measure Information:
Title
Response rate (by contrast CT scan)
Time Frame
12 weeks after completion of adjuvant chemotherapy or within 4 weeks after premature study discontinuation
Secondary Outcome Measure Information:
Title
Progression Free survival (PFS)
Time Frame
Day 1 of treatment to the date of objective disease progression
Title
Overall survival (OS)
Time Frame
Day 1 of treatment to the date of death due to any cause
Title
Adverse events (including oesophageal and pulmonary toxicities)
Time Frame
Informed consent signature up to 12 weeks after completion of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Learn more about this trial

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

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