Comparable Study of Different Thoracic Radiotherapy Regimens for Extensive Stage Small Cell Lung Cancer

Lung Neoplasms Clinical Trial

Official title:

Randomized Phase III Study Comparing Different Thoracic Radiotherapy Regimens in Patients With Extensive Stage Small Cell Lung Cancer Who Respond to Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02675088
• Other study ID #: CH-L-045/1
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: December 2019

Study information

• Verified date: April 2019
• 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

Most patients with extensive stage small-cell lung cancer (ES-SCLC) who undergo chemotherapy, and prophylactic cranial irradiation, have persistent intrathoracic disease. A Dutch study recently proved that thoracic radiotherapy(TRT), using 30 Gy in 10 fractions of 3 Gy, could improve 2-year overall survival(OS) of this patient group compared with non-TRT group. But intrathoracic progression was still high, either with or without progression elsewhere, occurring in 43.7% in the TRT group. The ideal TRT regimen for ES-SCLC is undefined. Maybe higher dose can provide better local control(LC) and overall survival. In this study, the investigators propose to give an increased dose of TRT to determine whether higher dose will improve 2-year OS, LC and progression-free survival.

Description:

This is a multicenter, prospective, randomised phase III study. For patients with ES-SCLC who respond to chemotherapy after four to six cycles of standard chemotherapy (platinum etoposide), 45Gy/15F of thoracic radiotherapy will be used in experimental arm, while 30Gy/10F of thoracic radiotherapy 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: 186
• Est. completion date: December 2019
• 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.

• Extensive stage small-cell lung cancer (ES-SCLC), was characterized by tumors beyond the hemithorax, hilar, mediastinal, and supraclavicular nodes. According to 2007 AJCC cancer staging 7th edition, stage I-IIIB with lung metastases and stage IV should be defined as LD.

• Has 1-4 extracranial metastatic lesions.

• No brain or central nervous system (CNS) metastases.

• No prior history of anti-tumor treatment.

• Response after 4 to 6 cycles of EP-based chemotherapy within the past 4 weeks.

• No severe internal diseases and no organ dysfunction.

• Written informed consent provided.

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:
• high-dose TRT
every day, Monday-Friday, for a total of 3 weeks, 45 Gy/ 3 Gy/ 15 f
• standard-dose TRT
every day, Monday-Friday, for a total of 2 weeks, 30 Gy/ 3 Gy/ 10 f

Locations

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

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 (1)

Slotman BJ, van Tinteren H, Praag JO, Knegjens JL, El Sharouni SY, Hatton M, Keijser A, Faivre-Finn C, Senan S. Use of thoracic radiotherapy for extensive stage small-cell lung cancer: a phase 3 randomised controlled trial. Lancet. 2015 Jan 3;385(9962):36 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	The time interval between diagnosis and death	2 years
Secondary	progression-free survival	The time interval between diagnosis and disease progression	2 years
Secondary	Incidence of tumor recurrence in local or regional area	Number of patients experienceing recurrences in local or regional area divided by number of all enrolled patients	2 years
Secondary	Incidence of radiotherapy and chemotherapy induced toxicities assessed by CTCAE v 4.0	Number of patients experienceing any toxicities induced by radiotherapy or chemotherapy divided by number of all enrolled patients	2 years