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

Lung Neoplasms Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01266512
• Other study ID #: DOCET_L_05158
• Secondary ID: U1111-1115-3573
• Status: Completed
• Phase: Phase 2
• First received: December 23, 2010
• Last updated: July 15, 2014
• Start date: January 2011
• Est. completion date: March 2014

Study information

• Verified date: July 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Primary Objective:

• Response rate (by contrast CT scan)

Secondary Objectives:

• Progression-free survival (PFS)

• Overall survival (OS)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Sanofi-Aventis Administrative Office	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate (by contrast CT scan)		12 weeks after completion of adjuvant chemotherapy or within 4 weeks after premature study discontinuation	No
Secondary	Progression Free survival (PFS)		Day 1 of treatment to the date of objective disease progression	No
Secondary	Overall survival (OS)		Day 1 of treatment to the date of death due to any cause	No
Secondary	Adverse events (including oesophageal and pulmonary toxicities)		Informed consent signature up to 12 weeks after completion of treatment	Yes