Simultaneous Integrated Boost vs. Routine IMRT in Limited-stage Small-cell Lung Cancer

Small-cell Lung Cancer Clinical Trial

Official title:

A Randomized Phase III Study of Comparison Between Simultaneous Integrated Boost (SIB) Intensity-modulated Radiation Therapy (IMRT) Versus Routine IMRT/VMAT in LD-SCLC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04500145
• Other study ID #: CH-L-072
• Status: Recruiting
• Phase: Phase 3
• Start date: July 20, 2017
• Est. completion date: October 20, 2021

Study information

• Verified date: January 2021
• Source: Chinese Academy of Medical Sciences
• Contact: zongmei zhou, Professor
• Phone: 86 13801389769
• Email: zhouzongmei2013[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Thoracic radiotherapy concurrent with chemotherapy stands for the standard regime for limited staged small cell lung cancer. Involved node radiation（INF） replaced elective node irradiation（ENI） as the more popular since several trails compared the two regimes. simultaneous integrated boost IMRT becomes mature with advancing in IMRT and VMAT. The investigator hypothesis that SIB-IMRT can confine the dose for organs at risk to reduce the toxicities compared with routine IMRT in limited disease small-cell lung cancer.

Description:

All patients recruited divided into two arms：SIB-IMRT or routine IMRT，in the routine arm，the prescription dose was 60Gy/2Gy/30f，and in the SIB arm ，60Gy was given to the field of the tumor and metastatic lymph nodes，50Gy was given to CR lesion and high-risk prevention. The physical advantages of SIB-IMRT are to reduce the radiation dose of organs that are at risk in the lungs, esophagus, and heart ensuring the adequate dose for tumor area at the same time. The investigators are carrying out this trial to compare the efficacy, safety, side effects, and type of failure of the two radiotherapy techniques, which will provide a new choice and reliable basis for the future dose-segmentation study of limited-stage small-cell lung cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: October 20, 2021
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 18-70 years old,KPS=80

• pathological small cell lung cancer

• staged as limited disease SCLC(contralateral hilar invasion not included)

• receive radiotherapy concurrent or sequential with chemotherapy,if induction chemotherapy,got PR or SD

• no other tumors

• No serious medical diseases and dysfunction of major organs

• understand this study,able to complete the treatment,accept the following up and sign the informed consent

• Contraception in women of childbearing age.

Exclusion Criteria:

• other malignant tumor(historically or simultaneously)curable non-melanoma skin cancer and cervical carcinoma in situ not included

• Uncontrolled heart disease or myocardial infarction within 6 months

• History of mental illness

• Pregnancy or Lactation

• uncontrolled diabetes?hypertension

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Carcinoma
• Small-cell Lung Cancer

Intervention

Radiation:
• SIB-IMRT
60Gy given to the tumor area,50Gy to the CR lesion or high-risk field at the same time
• routine IMRT
patients received IMRT or VMAT,with the prescription of 60Gy/2Gy/30F to the planning tumor volume ,concurrent or sequential with EP chemotherapy

Locations

Country	Name	City	State
China	Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progress-free survival	the rate of patients survival from the treatment to death or progress	2 year
Secondary	overall survival	rate of patients survival in 2 years	2 year
Secondary	local control rate	recurrence rate of local field in 2 years	2 year
Secondary	side-effects	the rate of radiation pneumatic?oesophagitis?haematological toxicity	3-6months after radiation