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

• Sponsor: Chinese Academy of Medical Sciences (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02675088
• Collaborator: Sun Yat-sen University (Other), Fudan University (Other), West China Hospital (Other), Zhejiang Cancer Hospital (Other), Tianjin Medical University Cancer Institute and Hospital (Other)
• Enrollment: 186
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site: 93
• Patients Per Site Per Month: 3.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Small Cell; Lung Neoplasms	Radiation: high-dose TRT; Radiation: standard-dose TRT	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 186 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Phase III Study Comparing Different Thoracic Radiotherapy Regimens in Patients With Extensive Stage Small Cell Lung Cancer Who Respond to Chemotherapy
• Actual Study Start Date: Dec 1, 2017
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Dec 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. overall survival [2 years]

   The time interval between diagnosis and death

Secondary Outcome Measures

1. progression-free survival [2 years]

   The time interval between diagnosis and disease progression

2. Incidence of tumor recurrence in local or regional area [2 years]

   Number of patients experienceing recurrences in local or regional area divided by number of all enrolled patients

3. Incidence of radiotherapy and chemotherapy induced toxicities assessed by CTCAE v 4.0 [2 years]

   Number of patients experienceing any toxicities induced by radiotherapy or chemotherapy divided by number of all enrolled patients

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences	Beijing	Beijing	China	100021
2	Zhejiang Cancer Hospital	Hangzhou	Zhejiang	China	0571

Sponsors and Collaborators

• Chinese Academy of Medical Sciences
• Sun Yat-sen University
• Fudan University
• West China Hospital
• Zhejiang Cancer Hospital
• Tianjin Medical University Cancer Institute and Hospital

Investigators

• Principal Investigator: LuHua Wang, MD, Cancer Hospital of CAMS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Luhua Wang, Vice President of Cancer hospital of CAMS, Chinese Academy of Medical Sciences
• ClinicalTrials.gov Identifier: NCT02675088
• Other Study ID Numbers: CH-L-045/1
• First Posted: Feb 5, 2016
• Last Update Posted: Apr 4, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Luhua Wang, Vice President of Cancer hospital of CAMS, Chinese Academy of Medical Sciences: Extensive Stage Small Cell Lung Cancer; thoracic radiotherapy; radiotherapy regimen
• Additional relevant MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma; Carcinoma, Small Cell

Study Results

No Results Posted as of Apr 4, 2019