A Prospective Study Comparing Two Radiotherapy Dose/Fraction and Omitting CTVs of the Primary Tumor in Limited SCLC

  • STATUS
    Recruiting
  • End date
    Jun 1, 2025
  • participants needed
    300
  • sponsor
    Zhejiang Cancer Hospital
Updated on 25 January 2021

Summary

For most of the patients with limited-stage SCLC, thoracic radiotherapy combined with chemotherapy is the standard treatment at present. However, the optimal dose / fraction of thoracic radiotherapy for limited-stage SCLC is still in controversial.This study is designed as a prospecitive randomized non-inferiority trial.

Details
Condition Limited Stage Small Cell Lung Cancer, Small Cell Lung Cancer Limited Stage, limited-stage small cell lung cancer
Treatment cisplatin, etoposide, Hypofractionated Radiotherapy, Hyperfractionated Radiotherapy
Clinical Study IdentifierNCT04543890
SponsorZhejiang Cancer Hospital
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have Small Cell Lung Cancer Limited Stage?
Do you have any of these conditions: limited-stage small cell lung cancer or Small Cell Lung Cancer Limited Stage or Limited Stage Small Cell Lung Cancer?
Histologically/cytologically confirmed diagnosis of SCLC
Radiologically (including brain CT/MRI, chest and abdomen contrasted CT and bone scintigraphy. PET/CT is recommended) confirmed limited-stage
Patients should be between 18 and 75 years old
ECOG performance status of 0-1 (Karnofsky performance status 80)
With adequate cardiac, pulmonary, bone marrow, hepatic and renal function
With weight loss no more than 10% within 6 months before diagnosis
Informed consent must be signed

Exclusion Criteria

Histology confirmed the mixed NSCLC components
Other primary malignant tumors appeared within 5 years before the first administration of the study drug, except for locally curable malignant tumors after radical treatment (such as basal or squamous cell skin cancer, superficial bladder cancer or prostate, cervical or breast carcinoma in situ, etc.)
Any disease or condition contraindicated by radiotherapy or chemotherapy
Malignant pleural effusion and pericardial effusion
Pregnant and lactating women
The investigator believes that the subject's complications or other circumstances may affect the compliance with the protocol or may not be suitable for the study
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