A Study of Pemetrexed Plus Cisplatin With Concurrent Radiation Therapy Followed by Docetaxel Consolidation in Patients With Inoperable Squamous Cell Lung Cancer
NCT ID: NCT02787473
Last Updated: 2016-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
54 participants
INTERVENTIONAL
2016-10-31
2020-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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pemetrexed+carboplatin/cisplatin+radiation therapy->docetaxel
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.
pemetrexed
Pemetrexed 500mg/m2 IV on day 1 every 4 weeks for 2 cycles
cisplatin
Cisplatin 25mg/m2 IV on day 1-3 every 4 weeks for 2 cycles
thoracic radiation therapy
Chemoradiotherapy, radiation 60Gy with 2 cycles of pemetrexed+ carboplatin/cisplatin
docetaxel
Docetaxel 60 mg/m2 IV on day 57 every 3 weeks for 2 cycles
Interventions
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pemetrexed
Pemetrexed 500mg/m2 IV on day 1 every 4 weeks for 2 cycles
cisplatin
Cisplatin 25mg/m2 IV on day 1-3 every 4 weeks for 2 cycles
thoracic radiation therapy
Chemoradiotherapy, radiation 60Gy with 2 cycles of pemetrexed+ carboplatin/cisplatin
docetaxel
Docetaxel 60 mg/m2 IV on day 57 every 3 weeks for 2 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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First People's Hospital of Hangzhou
OTHER
Responsible Party
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Locations
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Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Shirong Zhang, Dr.
Role: primary
Other Identifiers
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HZCH-2016-10
Identifier Type: -
Identifier Source: org_study_id