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Preliminary study for dosage of lobaplatin concurrent with radiotherapy for untreated locoregionally advanced non-small cell lung cancer

Phase I trial for lobaplatin chemotherapy concurrent with radiotherapy for untreated locoregionally advanced non-small cell lung cancer

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019830
Enrollment
Unknown
Registered
2018-12-02
Start date
2018-12-30
Completion date
Unknown
Last updated
2018-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

locoregionally advanced non-small cell lung cancer

Interventions

Case series:Different doses

Sponsors

the Fifth Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Histological or cytologically confirmed unresectable stage IIIA or IIIB (AJCC eighth edition) non-small cell lung cancer patients; 2. Aged 18-65 years old; 3. Untreated patients who have not undergone surgery, chemotherapy, biotherapy or radiation therapy before; 4. Estimated survival time = 3 months; 5. There are evaluable lesions; 6. The body general condition is scored by ECOG: 0-2 score. No major organ dysfunction, oxygen partial pressure = 10.64kPa. White blood cells = 4X10^9/L, hemoglobin = 9.5g/dL; absolute neutrophil count = 1.5X10^9/L; platelet count = 100X10^9/L; total bilirubin = 1.5 times the upper limit of normal level; alanine aminotransferase and cereal Transaminase = 2 times the upper limit of normal level; creatinine = 1.25 times the upper limit of normal level; and creatinine clearance rate = 60ml/min; 7. The patients who can complete follow-up information and can be obtained to understand the situation of the study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Stage T3N1M0 patients with contralateral hilar lymph node metastasis, total atelectasis, malignant pleural effusion or pericardial effusion; 2. Patients who do not meet the inclusion criteria of the pathological type, stage and survival status of; 3. Any unstable system is a disease, such as acute infection, major cardiovascular disease which myocardial infarction in the past 1 year is included, any severe liver, kidney or metabolic disease, metabolic disorders; 4. Except the following four malignant tumors which can be radically resected, such as in situ cervical cancer, basal or squamous cell skin cancer, breast intraductal carcinoma in situ, organ-limited prostate cancer, any other malignant tumors within 5 years should be excluded; 5. The investigator believes that patients who may transmit human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) through blood or other body fluids should be excluded; 6. Breastfeeding and / or pregnant women.

Design outcomes

Primary

MeasureTime frame
Routine blood test;Liver and kidney function;Clinical physique;

Countries

China

Contacts

Public ContactZhong Lin

Department of Thoracic oncology, The cancer center of the fifth affiliated hospital of Sun Yat-sen University

linzhong123@163.com+86 13570604449

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026