Comparable Study of Different Thoracic Radiotherapy Regimens for Extensive Stage Small Cell Lung Cancer
Randomized Phase III Study Comparing Different Thoracic Radiotherapy Regimens in Patients With Extensive Stage Small Cell Lung Cancer Who Respond to Chemotherapy
1 other identifier
interventional
186
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2017
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2016
CompletedFirst Posted
Study publicly available on registry
February 5, 2016
CompletedStudy Start
First participant enrolled
December 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedApril 4, 2019
April 1, 2019
2 years
February 3, 2016
April 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival
The time interval between diagnosis and death
2 years
Secondary Outcomes (3)
progression-free survival
2 years
Incidence of tumor recurrence in local or regional area
2 years
Incidence of radiotherapy and chemotherapy induced toxicities assessed by CTCAE v 4.0
2 years
Study Arms (2)
high-dose TRT
EXPERIMENTALhigh-dose thoracic radiotherapy X-ray RT
standard-dose TRT
ACTIVE COMPARATORstandard-dose thoracic radiotherapy XRT
Interventions
every day, Monday-Friday, for a total of 3 weeks, 45 Gy/ 3 Gy/ 15 f
every day, Monday-Friday, for a total of 2 weeks, 30 Gy/ 3 Gy/ 10 f
Eligibility Criteria
You may qualify if:
- 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 beyond the hemithorax, hilar, mediastinal, and supraclavicular nodes. According to 2007 AJCC cancer staging 7th edition, stage I-IIIB with lung metastases and stage IV should be defined 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.
You may not qualify if:
- Malignant tumors of other sites. Non melanoma skin cancer and Cervical carcinoma in situ 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 chorionic gonadotrophin (HCG).
- Uncontrolled diabetes or hypertension.
- Interstitial pneumonia or Active pulmonary fibrosis.
- Acute bacterial or fungal infection.
- Oral or intravenous use of steroids.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chinese Academy of Medical Scienceslead
- Sun Yat-sen Universitycollaborator
- Fudan Universitycollaborator
- West China Hospitalcollaborator
- Zhejiang Cancer Hospitalcollaborator
- Tianjin Medical University Cancer Institute and Hospitalcollaborator
Study Sites (2)
Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 0571, China
Related Publications (1)
Slotman BJ, van Tinteren H, Praag JO, Knegjens JL, El Sharouni SY, Hatton M, Keijser A, Faivre-Finn C, Senan S. Use of thoracic radiotherapy for extensive stage small-cell lung cancer: a phase 3 randomised controlled trial. Lancet. 2015 Jan 3;385(9962):36-42. doi: 10.1016/S0140-6736(14)61085-0. Epub 2014 Sep 14.
PMID: 25230595RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
LuHua Wang, MD
Cancer Hospital of CAMS
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice President of Cancer hospital of CAMS
Study Record Dates
First Submitted
February 3, 2016
First Posted
February 5, 2016
Study Start
December 1, 2017
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
April 4, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share