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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

Zhejiang University logo

Zhejiang University

Status and phase

Unknown
Phase 2

Conditions

Squamous Cell Lung Cancer

Treatments

Drug: docetaxel
Radiation: thoracic radiation therapy
Drug: cisplatin
Drug: pemetrexed

Study type

Interventional

Funder types

Other

Identifiers

NCT02787473
HZCH-2016-10

Details and patient eligibility

About

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.

Enrollment

54 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

54 participants in 1 patient group

pemetrexed+carboplatin/cisplatin+radiation therapy->docetaxel
Experimental group
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.
Treatment:
Radiation: thoracic radiation therapy
Drug: pemetrexed
Drug: cisplatin
Drug: docetaxel

Trial contacts and locations

1

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Central trial contact

Shenglin Ma, MD

Data sourced from clinicaltrials.gov

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