Hypofractionated vs. Conventionally Fractionated Concurrent CRT for LD-SCLC

Phase III Randomized Study of Hypofractionated vs Conventionally Fractionated Concurrent Chemo-radiotherapy for Limited Disease Small Cell Lung Cancer

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02688036

Enrollment

860

Registered

2016-02-23

Start date

2016-02-01

Completion date

2023-12-01

Last updated

2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Small Cell, Lung Neoplasms

Keywords

Limited Disease Small Cell Lung Cancer, concurrent chemoradiotherapy, dose fractionation

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.

Interventions

RADIATIONhypofractionated concurrent chemoradiotherapy

For patients with Limited Disease Small Cell Lung Cancer, 45Gy/15F of radiotherapy with concurrent chemotherapy will be used in experimental arm.

RADIATIONconventionally fractionated concurrent chemoradiotherapy

For patients with Limited Disease Small Cell Lung Cancer, 60Gy/30F of radiotherapy with concurrent chemotherapy will be used in the control arm.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
overall survival	2 years

Secondary

Measure	Time frame	Description
disease free survival	2 years	—
local-regional failure (Incidence of tumor recurrence in local or regional area)	2 years	Incidence of tumor recurrence in local or regional area
toxicity (Incidence of radiotherapy and chemotherapy induced toxicities assessed by CTCAE v 4.0)	2 year	Incidence of radiotherapy and chemotherapy induced toxicities assessed by CTCAE v 4.0

Countries

China

Contacts

PRINCIPAL_INVESTIGATORLuHua Wang, MD

Cancer Hospital of CAMS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026