Comparable Study of Different Thoracic Radiotherapy Regim... | NCT02675088

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

NCT02675088

Sponsor

Chinese Academy of Medical Sciences

Status

Unknown status

Last Update Posted

Apr 4, 2019Actual

Enrollment

186Estimated

Phase

Not Applicable

Conditions

Carcinoma, Small Cell
Lung Neoplasms

Interventions

high-dose TRT
standard-dose TRT

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2017Actual

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Feb 3, 2016

First Submission Date that Met QC Criteria

Feb 3, 2016

First Posted Date

Feb 5, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2019

Last Update Posted Date

Apr 4, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Luhua Wang, Vice President of Cancer hospital of CAMS, Chinese Academy of Medical SciencesPrincipal Investigator

Lead Sponsor

Chinese Academy of Medical SciencesOTHER

Collaborators

Name	Class
Sun Yat-sen University	OTHER
Fudan University	OTHER
West China Hospital	OTHER
Zhejiang Cancer Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

186Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
high-dose TRT	Experimental	high-dose thoracic radiotherapy X-ray RT	Radiation: high-dose TRT
standard-dose TRT	Active Comparator	standard-dose thoracic radiotherapy XRT	Radiation: standard-dose TRT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
high-dose TRT	Radiation	every day, Monday-Friday, for a total of 3 weeks, 45 Gy/ 3 Gy/ 15 f	high-dose TRT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
overall survival	The time interval between diagnosis and death	2 years

Secondary Outcomes

Measure	Description	Time Frame
progression-free survival	The time interval between diagnosis and disease progression	2 years
Incidence of tumor recurrence in local or regional area	Number of patients experienceing recurrences in local or regional area divided by number of all enrolled patients

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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 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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
LuHua Wang, MD	Contact	+861087788799		wlhwq@yahoo.com

Overall Officials

Name	Affiliation	Role
LuHua Wang, MD	Cancer Hospital of CAMS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences	Recruiting	Beijing	Beijing Municipality	100021	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25230595	Result	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.

ID	Term
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

ID	Term
D018288	Carcinoma, Small Cell
D008175	Lung Neoplasms