Clinical trial NCT02675088: Comparable Study of Different Thoracic Radiotherapy Regimens for Extensive Stage Small Cell Lung Cancer
Official title: Randomized Phase III Study Comparing Different Thoracic Radiotherapy Regimens in Patients With Extensive Stage Small Cell Lung Cancer Who Respond to Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carcinoma, Small Cell
Lung Neoplasms
Keywords: Extensive Stage Small Cell Lung Cancer
thoracic radiotherapy
radiotherapy regimen
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Sun Yat-sen University
name: Fudan University
name: West China Hospital
name: Zhejiang Cancer Hospital
name: Tianjin Medical University Cancer Institute and Hospital
First posted: 2016-02-05
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: overall survival
timeFrame: 2 years
Secondary outcomes:
measure: progression-free survival
timeFrame: 2 years
measure: Incidence of tumor recurrence in local or regional area
timeFrame: 2 years
measure: Incidence of radiotherapy and chemotherapy induced toxicities assessed by CTCAE v 4.0
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences
state: Beijing
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Cancer Hospital of CAMS
name: LuHua Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.