A Study of Pemetrexed Plus Cisplatin With Concurrent Radiation Therapy Followed by Docetaxel Consolidation in Patients With Inoperable Squamous Cell Lung Cancer

Phase 2

• Conditions: Squamous Cell Lung Cancer
• Interventions: Drug: pemetrexed; Drug: cisplatin; Radiation: thoracic radiation therapy; Drug: docetaxel

• Registration Number: NCT02787473
• Lead Sponsor: First People's Hospital of Hangzhou

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-04-22
• Study First Submitted QC: 2016-05-31
• Study First Posted: 2016-06-01
• Study Start: 2016-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-23
• Last Update Posted: 2016-11-25
• Primary Completion: 2019-10
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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;

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pemetrexed+carboplatin/cisplatin+radiation therapy->docetaxel	thoracic radiation therapy	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+carboplatin/cisplatin+radiation therapy->docetaxel	pemetrexed	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+carboplatin/cisplatin+radiation therapy->docetaxel	cisplatin	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+carboplatin/cisplatin+radiation therapy->docetaxel	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.

Primary Outcome Measures

Name	Time	Method
Overall Response Rate	3 years

Secondary Outcome Measures

Name	Time	Method
Rate of CTCAE grade 2 or higher radiation pneumonitis	1 years	The investigators will assess the rate of symptomatic radiation pneumonitis in patients who received the radiation therapy
Overall Survival	3 years
Local control rate	3 years
The short-term quality of life (QOL) assessed using FACT-E score	4 months	FACT-E score at the 4 months after docetaxel consolidation therapy

Trial Locations

Locations (1)

Hangzhou First People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China