Hypofractionated vs. Conventionally Fractionated Concurrent CRT for LD-SCLC

NCT ID: NCT02688036

Last Updated: 2018-01-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 860 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2020-05-31

Brief Summary

The purpose of this study is to determine whether hypofractionated concurrent chemo-radiotherapy has the same efficiency as conventionally fractionated concurrent chemo-radiotherapy in Limited Disease Small Cell Lung Cancer.

Detailed Description

For patients with Limited Disease Small Cell Lung Cancer, 45Gy/15F of radiotherapy with concurrent chemotherapy will be used in experimental arm. While 60Gy/30F of radiotherapy with concurrent chemotherapy will be used in the control arm. Both survival and toxicity of the two arms will be observed and compared.

Conditions

Carcinoma, Small Cell; Lung Neoplasms

Study Design

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

Study Groups

hypofractionated CRT

hypofractionated concurrent chemoradiotherapy

Group Type: EXPERIMENTAL

hypofractionated concurrent chemoradiotherapy

Intervention Type: RADIATION

For patients with Limited Disease Small Cell Lung Cancer, 45Gy/15F of radiotherapy with concurrent chemotherapy will be used in experimental arm.

conventionally fractionated CRT

conventionally fractionated concurrent chemoradiotherapy

Group Type: ACTIVE_COMPARATOR

conventionally fractionated concurrent chemoradiotherapy

Intervention Type: RADIATION

For patients with Limited Disease Small Cell Lung Cancer, 60Gy/30F of radiotherapy with concurrent chemotherapy will be used in the control arm.

Interventions

hypofractionated concurrent chemoradiotherapy

For patients with Limited Disease Small Cell Lung Cancer, 45Gy/15F of radiotherapy with concurrent chemotherapy will be used in experimental arm.

Intervention Type: RADIATION

conventionally fractionated concurrent chemoradiotherapy

For patients with Limited Disease Small Cell Lung Cancer, 60Gy/30F of radiotherapy with concurrent chemotherapy will be used in the control arm.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• 18~70 years old, ECOG 0-2
• patients with histologically or cytologically proved small cell lung cancer
• Limited disease (LD), was characterized by tumors confined to one hemithorax. It may include ipsilateral hilar, both mediastinum and both supraclavicular nodes. Metastatic lymph nodes were defined as lymph nodes with short diameter of more than 1cm or FDG uptake in PET. The thickness of pleural effusion was less than 1cm unless malignant pleural effusion was cytologically proved. In a word, stage I-IIIB excluding the patients with lung metastases should be defined as LD according to AJCC cancer staging 7th edition.
• No progression after 2 cycles of chemotherapy with EP.
• No prior history of anti-tumor treatment.
• No severe internal diseases and no organ dysfunction
• Written informed consent provided and

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

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

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: collaborator

Fudan University

OTHER

Sponsor Role: collaborator

West China Hospital

OTHER

Sponsor Role: collaborator

Zhejiang Cancer Hospital

OTHER

Sponsor Role: collaborator

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: collaborator

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Luhua Wang

Vice President of Cancer hospital of CAMS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

LuHua Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Hospital of CAMS

Locations

Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

LuHua Wang, MD

Role: CONTACT

wlhwq@yahoo.com

861087788799

Facility Contacts

LUHUA WANG, MD

Role: primary

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Other Identifiers

CH-L-045/2

Identifier Type: -

Identifier Source: org_study_id