Comparable Study of Different Thoracic Radiotherapy Regimens for Extensive Stage Small Cell Lung Cancer

Last updated: April 2, 2019
Sponsor: Chinese Academy of Medical Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Cancer

Small Cell Lung Cancer

Treatment

N/A

Clinical Study ID

NCT02675088
CH-L-045/1
  • Ages 18-70
  • All Genders

Study Summary

Most patients with extensive stage small-cell lung cancer (ES-SCLC) who undergo chemotherapy, and prophylactic cranial irradiation, have persistent intrathoracic disease. A Dutch study recently proved that thoracic radiotherapy(TRT), using 30 Gy in 10 fractions of 3 Gy, could improve 2-year overall survival(OS) of this patient group compared with non-TRT group. But intrathoracic progression was still high, either with or without progression elsewhere, occurring in 43.7% in the TRT group. The ideal TRT regimen for ES-SCLC is undefined. Maybe higher dose can provide better local control(LC) and overall survival. In this study, the investigators propose to give an increased dose of TRT to determine whether higher dose will improve 2-year OS, LC and progression-free survival.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 - 70 years old, ECOG 0-2.

  • Patients with histologically or cytologically proved small cell lung cancer.

  • Extensive stage small-cell lung cancer (ES-SCLC), was characterized by tumors beyondthe hemithorax, hilar, mediastinal, and supraclavicular nodes. According to 2007 AJCCcancer staging 7th edition, stage I-IIIB with lung metastases and stage IV should bedefined as LD.

  • Has 1-4 extracranial metastatic lesions.

  • No brain or central nervous system (CNS) metastases.

  • No prior history of anti-tumor treatment.

  • Response after 4 to 6 cycles of EP-based chemotherapy within the past 4 weeks.

  • No severe internal diseases and no organ dysfunction.

  • Written informed consent provided.

Exclusion

Exclusion Criteria:

  • Malignant tumors of other sites. Non melanoma skin cancer and Cervical carcinoma insitu were not included if curable.

  • Active heart disease or acute myocardial infarction happen in six months.

  • Psychiatric history.

  • Pregnant woman or woman need to breast feed or woman with positive chorionicgonadotrophin (HCG).

  • Uncontrolled diabetes or hypertension.

  • Interstitial pneumonia or Active pulmonary fibrosis.

  • Acute bacterial or fungal infection.

  • Oral or intravenous use of steroids.

Study Design

Total Participants: 186
Study Start date:
December 01, 2017
Estimated Completion Date:
December 31, 2019

Study Description

This is a multicenter, prospective, randomised phase III study. For patients with ES-SCLC who respond to chemotherapy after four to six cycles of standard chemotherapy (platinum etoposide), 45Gy/15F of thoracic radiotherapy will be used in experimental arm, while 30Gy/10F of thoracic radiotherapy will be used in the control arm. Both survival and toxicity of the two arms will be observed and compared.

Connect with a study center

  • Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences

    Beijing, Beijing 100021
    China

    Active - Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 0571
    China

    Active - Recruiting

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