Clinical trial NCT02787473: A Study of Pemetrexed Plus Cisplatin With Concurrent Radiation Therapy Followed by Docetaxel Consolidation in Patients With Inoperable Squamous Cell Lung Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Squamous Cell Lung Cancer
Keywords: Squamous cell lung cancer
Pemetrexed
Radiosensitivity
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
First posted: 2016-06-01
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Overall Response Rate
timeFrame: 3 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 3 years
measure: Local control rate
timeFrame: 3 years
measure: The short-term quality of life (QOL) assessed using FACT-E score
timeFrame: 4 months
measure: Rate of CTCAE grade 2 or higher radiation pneumonitis
timeFrame: 1 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
Study officials:
References: