Hypofractionated vs. Conventionally Fractionated Concurrent CRT for LD-SCLC

Lung Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02688036
• Other study ID #: CH-L-045/2
• Status: Recruiting
• Phase: Phase 3
• First received: November 20, 2015
• Last updated: December 28, 2017
• Start date: February 2016
• Est. completion date: May 2020

Study information

• Verified date: December 2017
• Source: Chinese Academy of Medical Sciences
• Contact: LuHua Wang, MD
• Phone: 861087788799
• Email: wlhwq[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 860
• Est. completion date: May 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Small Cell
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Radiation:
• 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.
• 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.

Locations

Country	Name	City	State
China	Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences	Beijing

Sponsors (6)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences	Fudan University, Sun Yat-sen University, Tianjin Medical University Cancer Institute and Hospital, West China Hospital, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

References & Publications (34)

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		2 years
Secondary	disease free survival		2 years
Secondary	local-regional failure (Incidence of tumor recurrence in local or regional area)	Incidence of tumor recurrence in local or regional area	2 years
Secondary	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	2 year