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NCT Number: NCT06427460

Central-boost Ablative Radiation Therapy for Solid Tumors (CBART)

In the case of large tumors or tumors closely adjacent to organs at risk, ablative doses offered by stereotactic body radiation therapy (SBRT) could not be delivered. Therefore, a technique that could provide high radiation doses to tumors without increasing of risks of severe adverse effects is required.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Huojun Zhang

Shanghai, Shanghai Municipality, 200433, China

Location status: Recruiting

Location contact

Huojun Zhang, M.D.

PRINCIPAL_INVESTIGATOR

Xiaofei Zhu

CONTACT

[email protected]

86-021-31162222

About this study

Regarding the advanced stage tumor, especially tumors with large volumes or closely adjacent to organs at risk, patients are not candidates for surgical resection. Therefore, raduitherapy may be the optimal local therapy to ameliorate symptoms and be combined with systemic therapy, including chemotherapy, targeted therapy or immunotherapy. However, for those tumors, ablative doses could not be given due to large volumes and abutting to organs at risk.

In order to solve the problem, spatially fractionated radiation therapy (SFRT) is used. In details, it was performed based on grid or lattice, which creates several cylindrical high-radiation-dose areas in tumors. Nevertheless, the ablative dose areas are limited albeit with SFRT, which may not greatly improve tumor local. Hence, we create an inner and complete inner gross tumor volume that would be delivered ablative radiation doses, which is named as central-boost ablative radiation therapy (CBART). We aim to investigate the efficacy and safety of CBART in large tumors or tumors adjacent to organs at risk.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18-75 years.
  • Pathologically confirmed lung, liver, pancreas or retroperitoneal malignant tumor.
  • Oligometastasis in the case of metastatic tumor
  • the shortest diameter ≥2cm or the distance from the tumor to the organs at risk less than 5mm
  • ECOG of 0 to 1 point
  • No abnormality in blood routine test, liver and kidney function test and coagulation test (White blood cell count ≥4.0×10^9/L, neutrophil count ≥2.0×10^9, hemoglobin level ≥100g/L, platelet count ≥100×10^9/L, ALT and AST level < 2.5 times the upper limit of normal, total bilirubin and creatinine level within the normal, international normalized ratio <2)

Exclusion criteria

  • History of radiotherapy for the lesion
  • History of tumor within 5 years
  • ECOG ≥2 points
  • Significant abnormality in blood routine test, liver and kidney function test and coagulation test
  • Active inflammatory bowel disease in the case of pancreas or retroperitoneal tumor
  • Gastrointestinal bleeding or perforation within 6 months in the case of pancreas or retroperitoneal tumor
  • Infections required antibiotics
  • Heart or respiratory insufficiency
  • Pregnant or breastfeeding women

Treatment and study plan

Central-boost ablative dose delivered by stereotactic body radiation therapy

Radiation

An inner and complete gross tumor volume (iGTV) is created within the gross tumor volume (GTV). For the liver or lung tumor, the convetional radiation dose is 35-45Gy/5f. Regarding the pancreatic tumor or retroperitoneal tumor, the radiation dose is 30-40Gy/5f. Hence, the radiation dose of iGTV should not be less than 120% of the dose of GTV.

Primary outcomes

  1. One-year local control will be determined.

    Time frame: 1 year

    The proportion of patients without tumor local progression at one year. The progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Secondary outcomes

  1. Overall survival will be determined.

    Time frame: 2 years

    The time from the enrollment to death.

  2. Progression free survival will be determined.

    Time frame: 2 years

    The time from the enrollment to documentation of any clinical or radiological disease progression or death, whichever occurred first. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

  3. Treatment related adverse events

    Time frame: 2 years

    Treatment-related adverse effects are determined by National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.

Study contacts

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

Xiaofei Zhu

CONTACT

[email protected]

86-021-31162222

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

Central-boost Ablative Radiation Therapy for Large Tumors or Tumors Adjacent to Organs at Risk

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
May 23, 2024
Registry last updated
May 23, 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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