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A phase II clinical trail to study of combined chemotherapy with late-course hypofractionated radiotherapy for limited-stage small cell lung cancer

A phase II clinical trail to study of combined chemotherapy with late-course hypofractionated radiotherapy for limited-stage small cell lung cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-17013640
Enrollment
Unknown
Registered
2017-12-02
Start date
2017-12-01
Completion date
Unknown
Last updated
2017-12-11

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

Conditions

small cell lung cancer

Interventions

small cell lung cancer:combined chemotherapy with late-course hypofractionated radiotherapy

Sponsors

Shanghai Pulmonary Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) histological or pathological cytology confirmed as small cell lung cancer; 2) limited stage; 3) aged 18-75 years; 4) ECOG score 0-2; 5) weight loss was less than 10% within 6 months before radiotherapy; 6) no serious medical diseases; 7) cardiac function: no serious heart disease and coronary heart disease history; 8) lung function: FEV1 > 0.75 L, or FEV1/FVC >0.7 (in the case of using or not using bronchodilator) or the use of bronchodilator after FEV1/FVC is less than or equal to 0.7 but FEV1 is more than 50% of the expected value; 9) bone marrow function: white blood cell count is greater than 4,000 mu/L, hemoglobin is greater than 9 g/dL (without blood transfusion), neutrophil count is greater than 2,000mu/L, platelet count is greater than 100, 000 mu /L; 10) liver function: total bilirubin < 1.5 times normal value upper limit, AST (SGOT)/ALT (SGPT) less than 2.5 times normal value upper limit; 11) kidney function: creatinine is less than 2.5 mg/dl; 12) have not chest radiotherapy before; 13) no other primary tumor before treatment; 14) non-pregnant or nursing women; 15) there was no progress after 1 to 2 courses of chemotherapy, etoposide + platinum group; 16) the patient signed informed consent.

Exclusion criteria

Exclusion criteria: 1) non-small cell lung cancer; 2) brain metastasis; 3) infection that was not controlled; 4) participating in other clinical studies; 5) pregnancy or breastfeeding; 6) having a distinct neurological or psychiatric history, including epilepsy or dementia; 7) malignant tumors that have been diagnosed with other activities in the past 5 years, with the exception of basal cell carcinoma or in-situ carcinoma of the cervix; 8) chest water and ascites that cannot be controlled before entering the group; 9) weight loss was significantly decreased in the first 6 weeks of the group (greater than 10%); 10) the progress of the disease (except for partial progress) of the patients with 1 to 2 courses of chemotherapy with etoposide + platinum group; 11) severe drug allergy; 12) With history of chest radiotherapy.

Design outcomes

Primary

MeasureTime frame
progression-free survival (PFS);radiation-induced pulmonary injury;acute radiation esophagitis;

Secondary

MeasureTime frame
overall survival;CR;PR;

Countries

China

Contacts

Public ContactShi-Xiong Liang

Shanghai Pulmonary Hospital

shixliang@vip.sina.com+86 13917716605

Outcome results

None listed

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