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Completed

NCT Number: NCT02688036

Hypofractionated vs. Conventionally Fractionated Concurrent CRT for LD-SCLC

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences

Beijing, 100021, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hypofractionated concurrent chemoradiotherapy

Radiation

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

conventionally fractionated concurrent chemoradiotherapy

Radiation

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

Primary outcomes

  1. overall survival

    Time frame: 2 years

Secondary outcomes

  1. disease free survival

    Time frame: 2 years

  2. local-regional failure (Incidence of tumor recurrence in local or regional area)

    Time frame: 2 years

    Incidence of tumor recurrence in local or regional area

  3. toxicity (Incidence of radiotherapy and chemotherapy induced toxicities assessed by CTCAE v 4.0)

    Time frame: 2 year

    Incidence of radiotherapy and chemotherapy induced toxicities assessed by CTCAE v 4.0

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Collaborators

  • Fudan University
  • Sun Yat-Sen University Cancer Center
  • Tianjin Medical University Cancer Institute and Hospital
  • West China Hospital
  • Zhejiang Cancer Hospital

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2022
Study completion
2023
First posted
Feb 23, 2016
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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