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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)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Neoplasms

Thank you

Trial Information

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)


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response rate (by contrast CT scan)

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

Hong Kong: Ethics Committee

Study ID:

DOCET_L_05158

NCT ID:

NCT01266512

Start Date:

December 2010

Completion Date:

December 2015

Related Keywords:

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

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