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A phase II-III clinical study of the joint Lobaplatin and radiotherapy for esophageal cancer in elderly patients

A phase II-III clinical study of the joint Lobaplatin and radiotherapy for esophageal cancer in elderly patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-17011436
Enrollment
Unknown
Registered
2017-05-18
Start date
2017-05-17
Completion date
Unknown
Last updated
2017-05-22

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

Conditions

esophageal cancer

Interventions

Case series:radioplatin joint radiotherapy

Sponsors

Radiotherapy department of the First People's Hospital of Huai'an City
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The patient will be willing to participate in the study of the subject in accordance with the requirements of the study, to be able to cooperate with the experiment to complete observation and follow-up, and to sign informed consent forms. 2. esophageal squamous carcinoma confirmed by histopathological examination, in patients with clinical stage and the past 4 weeks did not accept the antitumor drugs except the experimental drug treatment, and can accept subject anti-tumor treatment; 3. has at least one measurable lesion (Diameter measured by CT is greater than 1cm and greater than 2cm by other measure); 4. ECOG less than or equal to 2 to be met the reuirement of chemotherapy; 5. Weight loss less than 10% in past six months and to be able to withstand radiotherapy; 6. ECG shows normal; 7. Aged over 65 years; In the first seven days duration of medication, the patient's bone marrow and liver and kidney function met the following conditions: The white blood cell (WBC) greater than 3000/uL, the absolute count of the neutrophils (ANC) greater than 1500/uL, and the platelets are greater than 100,000/uL, and the hemoglobin is greater than or equal to 9.0 g/dL; AST and ALT 2.5 times of the upper limit of normal (ULN), alkaline phosphatase acuities 4 times of the upper limit of normal value, total bilirubin acuities 1.5 times of the upper limit of normal value; The serum creatinine 1.5 times less than the ULN, and the blood urea nitrogen (BUN) 2.5 times greater than ULN. Prothrombin time (PTT) and Partial prothrombin time (PPTT) shorter than normal 1.5 folders; Left ventricular ejection fraction (LVEF) greater than or equal to 60% (doppler ultrasound).

Exclusion criteria

Exclusion criteria: 1. Pregnancy woman; 2. Complicated with acute infections, severe acute infection, suppurative and chronic infection, or the inpatient of the wound; 3. esophageal perforation (esophageal tracheal fistula or patients who may have esophageal tracheal fistulas) with clear symptoms and multiple distant metastases; 4. Received other anti-tumor treatment before enrollment; 5. coagulant function abnormal, have bleeding tendency (such as active peptic ulcer), or disease in accepting thrombolytic or anticoagulant therapy; 6. original serious heart disease, including: congestive heart failure, high-risk sexual beyond the control of the rhythm of the heart failure, unstable angina, half a year of myocardial infarction, severe valvular heart disease, and resistant hypertension; 7. patients with uncontrollable nerve, mental illness, or mental disorders, depending on the sex, cannot cooperation and adverse response for descriptive treatment; 8. severe liver cirrhosis, severe kidney dysfunction.

Design outcomes

Primary

MeasureTime frame
PFS;

Countries

China

Contacts

Public ContactHonglei Luo

Radiotherapy department of the First People's Hospital of Huai'an City

lhl6794@sina.com+86 15996169977

Outcome results

None listed

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