Treatment of larger tumor volumes or >= 2 lung tumors simultaneously in lung cancer patients using SBRT in a mean-lung dose escalation study

Phase 2

Recruiting

• Conditions: lung cancer; Non small cell lung cancer; 10038666; 10029107

• Registration Number: NL-OMON41422
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 35

Inclusion Criteria

Inclusion criteria for riskgroup A and B
- Weight loss < 10% in the last three months
- WHO-performance status <= 2 (see Appendix II)
- Medical inoperable patients or patients refusing surgery
- Chemotherapy is allowed in neoadjuvant and adjuvant setting, with exclusion of the period 4 weeks pre-SBRT and 6 weeks post-SBRT.
- Before patient registration, written informed consent must be given according to ICH/GCP, national and local regulations (see section 11.3).
- Check of inclusion by PI (h.peulen@nki.nl and j.belderbos@nki.nl*) by sending
oScreenshot of CT-thorax with tumor location
oCase summary
oTreatment plan
Risk group A specification (large lung tumors):
- NSCLC (Cytological or histological proven) patients with one peripheral tumor >5 cm with tumor staging cT2bN0M0 or cT3N0M0 (chest wall infiltration is no exclusion criteria, as long as the tumor diameter is > 5 cm).
- In patients without cytological or histological confirmation of NSCLC, a growing FDG-PET positive lesion (SUV >5) is accepted if a contra-indication for invasive diagnostic examination (or refusal) is present
- Or a single peripheral lung metastasis in inoperable patients with a diameter of > 5 cm. In case of first presentation of metastatic disease, cytological or histological proof is obligated.
Risk group B specification (lung metastases):
- Patients with 2 peripheral lprimary NSCLC <= 5 with tumor staging cT1-2aN0M0 (cytological/histological proven or growing and PET positive as described in section 5.2.2)
- Patients having two or more peripheral lung tumors without unacceptable dose overlap
- Or patients with >= 2 peripheral lung metastases <= 5 cm of any origin at any location in the lung. In case of first presentation of metastatic disease, cytological or histological proof is obligated. This is not necessary in case of a history of an already proven disseminated disease.

Exclusion Criteria

- patients with more lung tumors/metastases who will very likely be retreated within 6 months
- Patients with central tumors
- Pancoast tumors
- Prior radiotherapy treatment to the thorax.
- Patients previously treated with adriamycin agents in case of heart involvement within the treatment field
- FEV1 and DLCO less than 40 % of the age-adjusted normal value
- patients receiving any systemic treatment
- pregnancy
- patients receiving Bevacizumab within 3 months prior to SBRT or within 1 month post SBRT.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary objective: The MLD that is associated with a 20% chance on dose<br /><br>limiting toxicity with a confidence interval of 10%.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives:<br /><br>- local control<br /><br>- regional control<br /><br>- overall survival<br /><br>- quality of life</p><br>