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Value assessment of contralateral esophagus-sparing technique in hyperfractionated radiotherapy for limited-stage small cell lung cancer

Value assessment of contralateral esophagus-sparing technique in hyperfractionated radiotherapy for limited-stage small cell lung cancer: a single-center, prospective, randomized controlled study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088886
Enrollment
Unknown
Registered
2024-08-28
Start date
2022-08-08
Completion date
Unknown
Last updated
2024-09-02

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

Conditions

Lung cancer

Interventions

Test group:Using the contralateral esophagus-sparing technique (CEST) in radiotherapy planning
Control group:Adopting the conventional esophageal dose constraints based on RTOG standards

Sponsors

Shanghai Pulmonary Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) Age 18 to 85 years old; 2) Small cell lung cancer confirmed by histology or cytology; 3) confirmed limited stage (stage I-III, according to the 8th edition of AJCC); 4) Must have tumor lesions (including primary tumor or involved lymph nodes) within 1 cm of the esophagus on recent CT images; 5) Must have adequate organs function; 6) Females of childbearing potential must undergo a serum pregnancy test before the start of radiotherapy, and the result is negative; 7) ECOG PS 0-1; expected survival period = 12 weeks; 8) The subjects voluntarily joined the study and signed the informed consent form. They had good compliance and cooperated with the follow-up.

Exclusion criteria

Exclusion criteria: 1) With a history of tumor that has received thoracic radiotherapy in the past; 2) Tumors suspected or known to invade the esophagus; 3) Previously diagnosed with reflux esophagitis and not completely relieved; 4) Complicated with other diseases such as cardiovascular, urinary, digestive, hematopoietic, endocrine and metabolic systems, etc., with serious complications, liver and kidney insufficiency, and mental illness; 5) Patients who are pregnant or lactating women; 6) Patients who do not follow the doctor's advice, could not judge the curative effect or with incomplete clinical data which would affect the judgment of curative effect; 7) Patients with poor complications or unable to cooperate as judged by the doctor; 8) Researchers consider as not appropriate to participate in; 9) Patients refused to sign the informed consent form after a specific explanation; 10) With a history of allergic reactions to the chemotherapy drugs used.

Design outcomes

Primary

MeasureTime frame
Severe esophagitis incidence;

Secondary

MeasureTime frame
Objective Response Rate;Disease Control Rate;Overall survival;

Countries

China

Contacts

Public ContactYaping Xu, Hui Liu

Shanghai Pulmonary Hospital

xuyaping1207@163.com+86 21 6511 5006

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026