Clinical trial · Interventional
A Study of Pemetrexed Plus Cisplatin With Concurrent Radiation Therapy Followed by Docetaxel Consolidation in Patients With Inoperable Squamous Cell Lung Cancer
A Phase II Study of Pemetrexed Plus Cisplatin With Concurrent Radiation Therapy Followed by Every-21-Day Docetaxel Consolidation in Patients With Inoperable Stage IIIA/B Squamous Cell Lung Cancer
NCT02787473CI-TRIAL-00024904unknownPhase 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)
To evaluate the efficacy and toxicity of patients with inoperable squamous cell lung cancer treated with pemetrexed plus cisplatin with concurrent radiation therapy followed by docetaxel consolidation. An exploratory biomarker analysis in blood and tumor samples is also planned.
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 |
|---|---|---|---|
| Squamous Cell Lung Cancer | Lung Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| pemetrexed | Drug | Pemetrexed | ALIAS |
| thoracic radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- pemetrexed+carboplatin/cisplatin+radiation therapy->docetaxel
- description
- Patients received pemetrexed 500mg/m2 days 1,29+cisplatin 25 mg/m2 days 1-3,29-31 + Radiation 6000 cGy (200 cGy/day). Patients with complete response(CR), partial response(PR) or stable disease(SD) with manageable toxicity received docetaxel 60 mg/m2 days 57,78.
- interventionNames
- Drug: pemetrexed
- Drug: cisplatin
- Radiation: thoracic radiation therapy
- Drug: docetaxel
Primary outcomes (1)
- measure
- Overall Response Rate
- timeFrame
- 3 years
Secondary outcomes (4)
- measure
- Overall Survival
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed stage IIIA/ IIIB squamous cell lung cancer; * All sites of disease must be amenable to definitive radiotherapy; * Age 18 years to 75 years; * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2; * Forced expiratory volume in 1 second(FEV1)\> 0.75L; * No previous chest radiotherapy, immunotherapy or biotherapy; * Adequate bone marrow, liver and renal function, as specified below: Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L; Hemoglobin ≥ 8 g/dL; Platelets ≥ 100 x 109/L; Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) ; Aspartate transaminase(AST) and alanine Transaminase(ALT) ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present; Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal. * For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment * Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter; * Patients and their family signed the informed consents; Exclusion Criteria: * Active infection; * History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias); * Malnutrition (loss of ≥ 20% of the original body weight); * Performance status: 3-4; * Sensor or motor neuropathy \> grade I; * Second primary malignancy, except for non-melanoma skin cancer; * Psychiatric illness or social situation that would preclude study compliance; * Pregnant or lactating women.
References
Publications (0)
Data not yet available
No reference posted for this study.