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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

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ClinicalTrials.gov Identifier: NCT02787473
Recruitment Status : Unknown
Verified November 2016 by First People's Hospital of Hangzhou.
Recruitment status was:  Recruiting
First Posted : June 1, 2016
Last Update Posted : November 25, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Squamous Cell Lung Cancer Drug: pemetrexed Drug: cisplatin Radiation: thoracic radiation therapy Drug: docetaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: pemetrexed+carboplatin/cisplatin+radiation therapy->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.
Drug: pemetrexed
Pemetrexed 500mg/m2 IV on day 1 every 4 weeks for 2 cycles

Drug: cisplatin
Cisplatin 25mg/m2 IV on day 1-3 every 4 weeks for 2 cycles
Other Name: platinol

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
Other Name: taxotere




Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: 3 years ]
  2. Local control rate [ Time Frame: 3 years ]
  3. The short-term quality of life (QOL) assessed using FACT-E score [ Time Frame: 4 months ]
    FACT-E score at the 4 months after docetaxel consolidation therapy

  4. Rate of CTCAE grade 2 or higher radiation pneumonitis [ Time Frame: 1 years ]
    The investigators will assess the rate of symptomatic radiation pneumonitis in patients who received the radiation therapy



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787473


Contacts
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Contact: Shenglin Ma, MD 0571-56007908 ext 086 mashenglin@medmail.com.cn

Locations
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China, Zhejiang
Hangzhou First People's Hospital Recruiting
Hangzhou, Zhejiang, China, 310006
Contact: Shirong Zhang, Dr.    086057156007650    shirley4444@gmail.com   
Sponsors and Collaborators
First People's Hospital of Hangzhou
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Responsible Party: First People's Hospital of Hangzhou
ClinicalTrials.gov Identifier: NCT02787473    
Other Study ID Numbers: HZCH-2016-10
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: November 25, 2016
Last Verified: November 2016
Keywords provided by First People's Hospital of Hangzhou:
Squamous cell lung cancer
Pemetrexed
Radiosensitivity
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Cisplatin
Docetaxel
Pemetrexed
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors