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

NCT ID: NCT02990780

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2023-12-31

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.

Detailed Description

Small-cell lung cancer accounts for approximately 13% of all lung cancers, and one-third of these patients present with limited stage SCLC at diagnosis. Currently the standard of care for LS-SCLC is concurrent chemotherapy and thoracic radiation therapy, with prophylactic cranial irradiation for those who achieve a good response after combined chemoradiotherapy, which has yielded a median survival of 15 to 23 months and 5-year survival rate up to 26%.

The optimal dose/fraction for LS-SCLC remains debatable. For SCLC with the characteristic of rapid doubling time and high growth fraction, there is also evidence suggesting that prolonged or interrupted overall radiation time contributes to treatment failure and poor outcome because of accelerated repopulation.In our previous study we also found that overall radiation time might play an important role in the treatment of LS-SCLC and that patients treated with a high biologically effective dose (BED, including time factor) of >57 Gy have favorable local control and survival.

This is a randomised prospective phase III study based on patients with limited stage SCLC, 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. The purpose of this study is to add more information to the current medical literature about the efficacy and safety of accelerated hypofractionated vs. conventionally fractionated concurrent chemo-radiotherapy for limited-stage SCLC.

Patients will be randomized into two groups. The control group will undergo the induction chemotherapy followed by conventionally fractionated concurrent chemo-radiotherapy.The experimental group will receive induction chemotherapy followed by accelerated hypofractionated concurrent chemo-radiotherapy.The investigators compare overall survival (OS) of the two groups.

Conditions

SCLC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventionally fractionated CRT

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

Group Type: ACTIVE_COMPARATOR

Conventionally fractionated concurrent chemo-radiotherapy

Intervention Type: RADIATION

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

Accelerated hypofractionated CRT

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

Group Type: EXPERIMENTAL

Accelerated hypofractionated concurrent chemo-radiotherapy

Intervention Type: RADIATION

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

Interventions

Conventionally fractionated concurrent chemo-radiotherapy

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

Intervention Type: RADIATION

Accelerated hypofractionated concurrent chemo-radiotherapy

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

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Chest Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiaolong Fu

Director, Department of Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaolong Fu, PhD

Role: CONTACT

xlfu1964@126.com

862122200000 ext. 3609

Yiting Wang

Role: CONTACT

yitingwang_1111@163.com

862122200000 ext. 3609

Facility Contacts

Xiaolong Fu, PhD

Role: primary

xlfu1964@126.com

+862122200000 ext. 3602

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Other Identifiers

SCHLC010

Identifier Type: -

Identifier Source: org_study_id