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NCT Number: NCT06037733

Primary Tumor Radiotherapy Omitting CTV for Patients With Advanced NSCLC Responded to Immunotherapy and Chemotherapy

The aim of this randomized study is to investigate pneumonitis, local tumor control, and survival outcomes of primary tumor radiotherapy omitting CTV for patients with advanced NSCLC responded to immunotherapy and chemotherapy

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location status: Recruiting

Location contact

Han Guang, MD

CONTACT

Han Guang, MD

PRINCIPAL_INVESTIGATOR

About this study

Studies have confirmed that systemic therapy combined with primary tumor radiotherapy can improve symptoms and prolong survival of advanced NSCLC. Our previous sturdy indicated that patients who received immunotherapy and subsequent radiotherapy suffered higher proportion of pneumonitis. Patients suffered grade 2 or more pneumonitis have worse prognosis. It is urged to optimize the radiotherapy dose and target volume for patients treated with immunotherapy and radiotherapy. According to retrospective and prospective studies, omitting primary tumor CTV radiation therapy showed no reduction in local control and survival for locally advanced NSCLC. It is postulated that omitting CTV radiation for patients responded to therapy with immunotherapy and chemotherapy will have less pneumonitis without sacrificing the local control rate. Omitting CTV may also retain better immune function which will facilitate the immunotherapy.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically or cytologically confirmed advanced non-small cell lung cancer (according to the 8th edition of the TNM cancer staging system of AJCC and UICC);
  • After over two cycles of chemotherapy combined with immunotherapy, the efficacy was CR, PR or SD (with a decreasing trend);
  • Age 18 to 80 years old, performance status 0-1;
  • measurable or evaluable lesions;
  • Survival expectancy is not less than 6 months;
  • adequate cardiac, pulmonary, renal, and hepatic and bone marrow function

Exclusion criteria

  • tumor progress after therapy with immunotherapy and chemotherapy
  • EGFR, ALK, or ROS1 mutation;
  • Previous thoracic radiotherapy;
  • grade 2 or more immune-related adverse events after induction immunotherapy
  • Previous malignancies (except stage I non-melanic skin cancer or cervical carcinoma in situ);
  • Pregnant or lactating women
  • undergoing other clinical trials;
  • Have serious comorbidities, including myocardial infarction, severe arrhythmia, severe cerebrovascular disease, ulcer disease, psychosis and uncontrollable diabetes;
  • Patients with HIV positive and undergoing antiviral therapy;
  • Active tuberculosis

Treatment and study plan

CTV omitted or delineated

Radiation

Patients who responded to the therapy (immunotherapy and chemotherapy) were randomly (1:1) assigned into CTV-omitted radiotherapy group or CTV-delineated radiotherapy group.

Primary outcomes

  1. grade 2 or more pneumonitis

    Time frame: up to 6 months

Secondary outcomes

  1. local/regional control rate

    Time frame: up to 12 months

  2. Progress free survival

    Time frame: up to 12 months

  3. grade 3 or more pneumonitis

    Time frame: up to 6 months

  4. grade 3 or more esophagitis

    Time frame: up to 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Guang Han, PhD

CONTACT

[email protected]

+86 13886048178

Sponsors and collaborators

Lead sponsor

Hubei Cancer Hospital

Other

Registry information

Official study title

Primary Tumor Radiotherapy Omitting Clinical Target Volume for Patients With Advanced Non Small Cell Lung Cancer Responded to Immunotherapy and Chemotherapy

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 14, 2023
Registry last updated
Mar 15, 2024

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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