Clinical trial NCT02688036: Hypofractionated vs. Conventionally Fractionated Concurrent CRT for LD-SCLC
Official title: Phase III Randomized Study of Hypofractionated vs Conventionally Fractionated Concurrent Chemo-radiotherapy for Limited Disease Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Carcinoma, Small Cell
Lung Neoplasms
Keywords: Limited Disease Small Cell Lung Cancer
concurrent chemoradiotherapy
dose fractionation
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: 2016-02-23
Enrollment: 860
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: 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.

Detailed 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.

Eligibility criteria: 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

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