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

Primary Purpose

Squamous Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
pemetrexed
cisplatin
thoracic radiation therapy
docetaxel
Sponsored by
First People's Hospital of Hangzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Squamous Cell Lung Cancer focused on measuring Squamous cell lung cancer, Pemetrexed, Radiosensitivity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hangzhou First People's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pemetrexed+carboplatin/cisplatin+radiation therapy->docetaxel

Arm Description

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.

Outcomes

Primary Outcome Measures

Overall Response Rate

Secondary Outcome Measures

Overall Survival
Local control rate
The short-term quality of life (QOL) assessed using FACT-E score
FACT-E score at the 4 months after docetaxel consolidation therapy
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

Full Information

First Posted
April 22, 2016
Last Updated
November 23, 2016
Sponsor
First People's Hospital of Hangzhou
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1. Study Identification

Unique Protocol Identification Number
NCT02787473
Brief Title
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

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First People's Hospital of Hangzhou

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Squamous Cell Lung Cancer
Keywords
Squamous cell lung cancer, Pemetrexed, Radiosensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pemetrexed+carboplatin/cisplatin+radiation therapy->docetaxel
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
pemetrexed
Intervention Description
Pemetrexed 500mg/m2 IV on day 1 every 4 weeks for 2 cycles
Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
platinol
Intervention Description
Cisplatin 25mg/m2 IV on day 1-3 every 4 weeks for 2 cycles
Intervention Type
Radiation
Intervention Name(s)
thoracic radiation therapy
Intervention Description
Chemoradiotherapy, radiation 60Gy with 2 cycles of pemetrexed+ carboplatin/cisplatin
Intervention Type
Drug
Intervention Name(s)
docetaxel
Other Intervention Name(s)
taxotere
Intervention Description
Docetaxel 60 mg/m2 IV on day 57 every 3 weeks for 2 cycles
Primary Outcome Measure Information:
Title
Overall Response Rate
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
3 years
Title
Local control rate
Time Frame
3 years
Title
The short-term quality of life (QOL) assessed using FACT-E score
Description
FACT-E score at the 4 months after docetaxel consolidation therapy
Time Frame
4 months
Title
Rate of CTCAE grade 2 or higher radiation pneumonitis
Description
The investigators will assess the rate of symptomatic radiation pneumonitis in patients who received the radiation therapy
Time Frame
1 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shenglin Ma, MD
Phone
0571-56007908
Ext
086
Email
mashenglin@medmail.com.cn
Facility Information:
Facility Name
Hangzhou First People's Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shirong Zhang, Dr.
Phone
086057156007650
Email
shirley4444@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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