Accelerated Hypofractionated vs. Conventionally Fractionated Concurrent CRT for LS-SCLC

NCT02990780 | Unknown Phase 3 DMC

• 1 other identifier: SCHLC010
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

Brief Summary

This protocol is a phase III randomized controlled trial (RCT) evaluating the efficacy of induction chemotherapy followed by accelerated hypofractionated vs. conventionally fractionated concurrent chemo-radiotherapy for limited-stage small cell lung cancer.

Conditions

SCLC

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  2 years

Secondary Outcomes (3)

• Progress Free Survival

  2 years

• Treatment-related adverse event

  1 years

• Locoregional recurrence-free survival

  2 years

Study Arms (2)

Conventionally fractionated CRT

ACTIVE COMPARATOR

Induction chemotherapy followed by conventionally fractionated concurrent chemo-radiotherapy,with prophylactic cranial irradiation for those who achieve a good response after combined chemoradiotherapy.

Radiation: Conventionally fractionated concurrent chemo-radiotherapy

Accelerated hypofractionated CRT

EXPERIMENTAL

Induction chemotherapy followed by accelerated hypofractionated concurrent chemo-radiotherapy,with prophylactic cranial irradiation for those who achieve a good response after combined chemoradiotherapy.

Radiation: Accelerated hypofractionated concurrent chemo-radiotherapy

Interventions

Conventionally fractionated concurrent chemo-radiotherapy RADIATION

5Fx/W,2Gy/Fx,Dt:PTV-G:60Gy/30F/6W.

Conventionally fractionated CRT

Accelerated hypofractionated concurrent chemo-radiotherapy RADIATION

5Fx/W,2.5Gy/Fx,Dt:PTV-G:55Gy/22F/4.4W.

Accelerated hypofractionated CRT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed SCLC.
• Male or female, aged 18-70 years.
• ECOG performance status 0 to 2.
• Limited-stage SCLC was defined as disease confined to one hemithorax and hilar,mediastinal, or supraclavicular nodes without pleural effusion, which can be safely encompassed within a tolerable radiation field.
• No prior thoracic RT.
• Weight loss in six months less than or equal to five percent.
• FEV1 greater than 0.75L.
• No severe internal diseases and no organ dysfunction.
• No prior history of any tumor.
• Skin test of CT contrast agents was negative.
• Had received 1-6 cycles of VP16 plus DDP/carboplatin.
• Voluntarily participated in this study and signed the informed consent form by himself or his agent. Had good compliance with the study procedures, and can cooperate with the relevant examination, treatment and follow-up.

You may not qualify if:

• Other tumor history(Except skin cancer/breast cancer/oral cancer/cervical cancer with expected lifespan more than or equal to 3 months).
• Multiple primary lung cancer.
• Any unstable systemic disease, including active infection, uncontrolled high blood pressure, unstable angina, newly observed angina pectoris within the past 3 months, congestive heart failure (New York heart association (NYHA) class II or higher), myocardial infarction onset six months before included into the group, and severe arrhythmia, liver, kidney, or metabolic disease in need of drug therapy. Human immunodeficiency virus (HIV) infection.
• Women in pregnancy or lactation .
• Patients with mental illness, considered as "can't fully understand the issues of this research".
• Had received other chemotherapy regimens,any radiotherapy or TKI.
• Refuse to write informed consent.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Related Publications (26)

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Central Study Contacts

Xiaolong Fu, PhD

CONTACT

862122200000; xlfu1964@126.com

Yiting Wang

CONTACT

862122200000; yitingwang_1111@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Radiation Oncology

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: December 13, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)