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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02787473
Other study ID # HZCH-2016-10
Secondary ID
Status Recruiting
Phase Phase 2
First received April 22, 2016
Last updated November 23, 2016
Start date October 2016
Est. completion date September 2020

Study information

Verified date November 2016
Source First People's Hospital of Hangzhou
Contact Shenglin Ma, MD
Phone 0571-56007908
Email mashenglin@medmail.com.cn
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 54
Est. completion date September 2020
Est. primary completion date October 2019
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
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
Radiation:
thoracic radiation therapy
Chemoradiotherapy, radiation 60Gy with 2 cycles of pemetrexed+ carboplatin/cisplatin
Drug:
docetaxel
Docetaxel 60 mg/m2 IV on day 57 every 3 weeks for 2 cycles

Locations

Country Name City State
China Hangzhou First People's Hospital Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
First People's Hospital of Hangzhou

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Response Rate 3 years No
Secondary Overall Survival 3 years No
Secondary Local control rate 3 years No
Secondary The short-term quality of life (QOL) assessed using FACT-E score FACT-E score at the 4 months after docetaxel consolidation therapy 4 months No
Secondary Rate of CTCAE grade 2 or higher radiation pneumonitis The investigators will assess the rate of symptomatic radiation pneumonitis in patients who received the radiation therapy 1 years No
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