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Dose-escalation by boosting radiation dose within the primary tumor on the basis of a pre-treatment FDG-PET-CT scan in stage IB, II and III NSCLC: A randomized phase II trial

Dose-escalation by boosting radiation dose within the primary tumor on the basis of a pre-treatment FDG-PET-CT scan in stage IB, II and III NSCLC: A randomized phase II trial - PET Boost

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43597
Enrollment
160
Registered
2009-11-09
Start date
2010-10-23
Completion date
Unknown
Last updated
2024-05-06

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 carcinom

Interventions

Radiotherapy with integrated boost on primary tumor on the basis of a pre-treatment FDG-PET-CT scan

Sponsors

Antoni van Leeuwenhoek Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Patients > 18 years with any subtype of pathologically proven, non-small cell lung cancer. The diagnosis may be established from biopsy or cytology obtained from the primary tumor and/ or from metastatic lymph nodes. 2. Minimal diameter of the primary tumor 4 cm, to allow boosting of sub-volumes. 3. UICC Stage T2-4, N0-3, M0 disease (TNM definition see appendix 2). 4. Only stage IB-II patients who are not candidates for surgery are eligible 5 Measurable disease at registration. 6. ECOG-performance status

Exclusion criteria

Exclusion criteria: 1. Prior radiotherapy to the thorax. 2. Clinical superior vena cava syndrome, malignant pleural effusion or malignant pericardial effusion. 3. Tumor growth in large blood vessels on spiral CT scan or encasement >50 % 4. Multiple nodules in the same or ipsilateral lobe(s). 5. Post-obstructive atelectasis or infiltration that cannot be distinguished from tumor on a CT-PET scan. 6. Patients with a diagnosis of other cancer within the last 3-years (except in situ carcinoma*s and / or non-melanoma skin cancer). 7. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Freedom from local failure in patients alive at 1 year

Secondary

MeasureTime frame
Toxicity Overall survival Quality of life Distant metastases Local and regional failures outside PTV Correlation between intra-tumor recurrence 3 and 12 months post radiotherapy based on average PET CT , 18F HX4 and DCE-CT scan Correlation between intra-tumor recurrence 3 and 12 months post radiotherapy based on average PET CT and 18F HX4. Correlation between distant metastases and 18F HX4 uptake in the primary tumor.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)