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Hypofractionated vs. Conventionally Fractionated Concurrent CRT for LD-SCLC

Primary Purpose

Carcinoma, Small Cell, Lung Neoplasms

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

hypofractionated concurrent chemoradiotherapy

conventionally fractionated concurrent chemoradiotherapy

About this trial

This is an interventional treatment trial for Carcinoma, Small Cell focused on measuring Limited Disease Small Cell Lung Cancer, concurrent chemoradiotherapy, dose fractionation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cancer Insititute and Hosiptal of Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

hypofractionated CRT

conventionally fractionated CRT

Arm Description

hypofractionated concurrent chemoradiotherapy

conventionally fractionated concurrent chemoradiotherapy

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

disease free survival

local-regional failure (Incidence of tumor recurrence in local or regional area)

Incidence of tumor recurrence in local or regional area

toxicity (Incidence of radiotherapy and chemotherapy induced toxicities assessed by CTCAE v 4.0)

Incidence of radiotherapy and chemotherapy induced toxicities assessed by CTCAE v 4.0

Full Information

NCT ID

NCT02688036

First Posted

November 20, 2015

Last Updated

December 28, 2017

Sponsor

Chinese Academy of Medical Sciences

Collaborators

Sun Yat-sen University, Fudan University, West China Hospital, Zhejiang Cancer Hospital, Tianjin Medical University Cancer Institute and Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02688036

Brief Title

Hypofractionated vs. Conventionally Fractionated Concurrent CRT for LD-SCLC

Official Title

Phase III Randomized Study of Hypofractionated vs Conventionally Fractionated Concurrent Chemo-radiotherapy for Limited Disease Small Cell Lung Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Unknown status

Study Start Date

February 2016 (Actual)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Academy of Medical Sciences

Collaborators

Sun Yat-sen University, Fudan University, West China Hospital, Zhejiang Cancer Hospital, Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Small Cell, Lung Neoplasms

Keywords

Limited Disease Small Cell Lung Cancer, concurrent chemoradiotherapy, dose fractionation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

860 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

hypofractionated CRT

Arm Type

Experimental

Arm Description

hypofractionated concurrent chemoradiotherapy

Arm Title

conventionally fractionated CRT

Arm Type

Active Comparator

Arm Description

conventionally fractionated concurrent chemoradiotherapy

Intervention Type

Radiation

Intervention Name(s)

hypofractionated concurrent chemoradiotherapy

Intervention Description

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

Intervention Name(s)

conventionally fractionated concurrent chemoradiotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

overall survival

Time Frame

2 years

Secondary Outcome Measure Information:

Title

disease free survival

Time Frame

2 years

Title

local-regional failure (Incidence of tumor recurrence in local or regional area)

Description

Incidence of tumor recurrence in local or regional area

Time Frame

2 years

Title

toxicity (Incidence of radiotherapy and chemotherapy induced toxicities assessed by CTCAE v 4.0)

Description

Incidence of radiotherapy and chemotherapy induced toxicities assessed by CTCAE v 4.0

Time Frame

2 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

LuHua Wang, MD

Phone

861087788799

wlhwq@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

LuHua Wang, MD

Organizational Affiliation

Cancer Hospital of CAMS

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences

City

Beijing

ZIP/Postal Code

100021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

LUHUA WANG, MD

First Name & Middle Initial & Last Name & Degree

Luhua Wang, MD

12. IPD Sharing Statement

Plan to Share IPD

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Hypofractionated vs. Conventionally Fractionated Concurrent CRT for LD-SCLC

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