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NCT Number: NCT06102161

Wedge Resection for Ground-glass Opacity-featured Lung Cancer (ECTOP-1020)

This is a clinical trial from the Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1020. The goal of this clinical trial is to confirm the therapeutic effect of Wedge resection for ground-glass opacity-featured lung cancer with a size less than 2cm and a consolidation-to-tumor ratio between 0.25 to 0.5.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fudan University Shanghai Cancer Center

Shanghai, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who sign the informed consent form and are willing to complete the study according to the plan;
  • Aged from 18 to 80 years old;
  • ECOG equals 0 or 1;
  • Not receiving lung cancer surgery before;
  • Intraoperative or postoperative pathologic diagnosis of lung adenocarcinoma;
  • Single lung nodules with ground-glass dominant or pure ground-glass on CT, or multiple lung nodules with the major lesion being the aforementioned nodules;
  • The nodule has a consolidation-to-tumor ratio (CTR) between 0.25 and 0.5 (including 0.25 and 0.5), and the nodule size is less than or equal to 2 cm;
  • peripheral type of nodes, namely, nodes in the outer 1/3 of the lung field.
  • cT1N0M0 tumors;
  • Complete tumor resection by wedge resection as assessed by the surgeon;
  • Not receiving chemotherapy or radiotherapy before.

Exclusion criteria

  • Postoperative pathologic diagnosis of adenocarcinoma in situ or minimally invasive adenocarcinoma.
  • CTR is not between 0.25-0.5 or nodule size greater than 2 cm;
  • Cannot be completely resected by wedge resection;
  • Invasive lung adenocarcinoma or lung malignancy other than lung adenocarcinoma diagnosed cytologically or pathologically;
  • Receiving lung cancer surgery before;
  • Receiving radiotherapy or chemotherapy.

Treatment and study plan

Wedge resection

Procedure

Wedge resection is a surgical procedure that is done to remove a wedge-shaped section of lung tissue, usually for treating lung cancer. A wedge resection is less invasive than some of the other surgical options used to remove lung cancer.

Primary outcomes

  1. 5-year overall survival

    Time frame: 5 years

    The event is defined as the death due to any causes.

Secondary outcomes

  1. 5-year recurrence-free survival

    Time frame: 5 years

    The event is defined as the tumor recurrence.

  2. Postoperative lung function (FEV1)

    Time frame: 5 years

    forced expiratory volume in one second (FEV1)

  3. Postoperative lung function

    Time frame: 5 years

    forced vital capacity (FVC)

  4. Sites of tumor recurrence and metastasis

    Time frame: 5 years

  5. Radical wedge resection (R0 resection) completion rate

    Time frame: 5 years

  6. Surgery-related complications

    Time frame: 5 years

Study contacts

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

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Wedge Resection for Ground-glass Opacity-featured Lung Cancer With Size Less Than 2cm and Consolidation-to-tumor Ratio Between 0.25 to 0.5: a Single-arm, Multi-center, Prospective, Confirmatory Phase III Trial

Important dates

Study start
2023
Primary completion
2025
Study completion
2030
First posted
Oct 26, 2023
Registry last updated
Oct 26, 2023

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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