Clinical trial · Interventional
Concurrent Chemoradiotherapy Using Intensity Modulated Radiotherapy (IMRT) & Docetaxel-cisplatin (or Carboplatin) Followed by Adjuvant Chemotherapy for Inoperable Stage III Non-small-cell Lung Cancer
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)
NCT01266512CI-TRIAL-00015106C-CRISPcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Primary Objective: * Response rate (by contrast CT scan) Secondary Objectives: * Progression-free survival (PFS) * Overall survival (OS)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IMRT & docetaxel-cisplatin
- 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
- interventionNames
- Drug: DOCETAXEL
- Radiation: Intensity Modulated Radiotherapy (IMRT)
- Drug: CISPLATIN
Primary outcomes (1)
- measure
- Response rate (by contrast CT scan)
- timeFrame
- 12 weeks after completion of adjuvant chemotherapy or within 4 weeks after premature study discontinuation
Secondary outcomes (3)
- measure
- Progression Free survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.