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

Squamous Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02787473
• Other study ID #: HZCH-2016-10
• 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

• Lung Neoplasms
• Squamous Cell Lung Cancer

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