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

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

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.

Study Overview

• Status: Unknown
• Conditions: Lung Neoplasms; Carcinoma, Small Cell
• Intervention / Treatment: Radiation: high-dose TRT; Radiation: standard-dose TRT

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 186
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences
      • Contact: LUHUA WANG, MD
      • Principal Investigator: Luhua Wang, MD
  • Zhejiang
    • Hangzhou, Zhejiang, China, 0571
      • Recruiting
      • Zhejiang Cancer Hospital
      • Contact: ming chen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high-dose TRT; high-dose thoracic radiotherapy X-ray RT	Radiation: high-dose TRT; every day, Monday-Friday, for a total of 3 weeks, 45 Gy/ 3 Gy/ 15 f
Active Comparator: standard-dose TRT; standard-dose thoracic radiotherapy XRT	Radiation: standard-dose TRT; every day, Monday-Friday, for a total of 2 weeks, 30 Gy/ 3 Gy/ 10 f

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	The time interval between diagnosis and death	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free survival	The time interval between diagnosis and disease progression	2 years
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
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

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Collaborators: Zhejiang Cancer Hospital; Sun Yat-sen University; Fudan University; West China Hospital; Tianjin Medical University Cancer Institute and Hospital
• Investigators: Principal Investigator: LuHua Wang, MD, Cancer Hospital of CAMS

Publications and helpful links

General Publications

• 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):36-42. doi: 10.1016/S0140-6736(14)61085-0. Epub 2014 Sep 14. Erratum In: Lancet. 2015 Jan 3;385(9962):28.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: February 3, 2016
• First Submitted That Met QC Criteria: February 3, 2016
• First Posted (Estimate): February 5, 2016

Study Record Updates

• Last Update Posted (Actual): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Extensive Stage Small Cell Lung Cancer; thoracic radiotherapy; radiotherapy regimen
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Carcinoma, Small Cell
• Other Study ID Numbers: CH-L-045/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No