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

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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41422
Enrollment
35
Registered
2011-09-12
Start date
2011-10-28
Completion date
Unknown
Last updated
2024-08-12

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

Conditions

lung cancer Non small cell lung cancer

Interventions

A treatment plan is generated with a prescription dose of 3x18 Gy. The MLD will be calculated in Normalized Total Dose (NTD) using the Linear Quadratic(LQ)-model. If the calculated MLD falls in a ri

Sponsors

Antoni van Leeuwenhoek Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for riskgroup A and B - Weight loss 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 = 2 peripheral lung metastases

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Primary objective: The MLD that is associated with a 20% chance on dose limiting toxicity with a confidence interval of 10%.

Secondary

MeasureTime frame
Secondary objectives: - local control - regional control - overall survival - quality of life

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)