Irradiation of Large Lung Tumors or Two or More Lung Metastases Simultaneously

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-22

Study Completion Date

2017-10-31

Brief Summary

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Treatment of larger tumor volumes or ≥ 2 lung metastases simultaneously in lung cancer patient using Stereotactic Body Radiation Therapy (SBRT) in a mean-lung dose escalation study.

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Detailed Description

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A phase I/II multicenter trial will be conducted in patients with medically inoperable with peripheral non small cell lung cancer (NSCLC) \> 5 cm without lymph node involvement (group A) or medically with ≥ 2 or more lung metastases (group B). Radiation pneumonitis is expected to be dose-limiting in these patients and there is evidence that the incidence is predicted by the mean lung dose (MLD). The MLD escalation will be performed separately in both patient groups, using a time-to-event continual reassessment method (TITE-CRM). All patients will receive 3-5 fractions SBRT to the lung tumor(s), with a minimum mean PTV dose ≥ 42 Gy. Fraction size may be downscaled based on the MLD constraint.

Conditions

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Lung Cancer Metastatic Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SBRT group A

escalate MLD in medically inoperable patients with tumors larger than 5 cm in diameter (primary or solitary metastases)

Group Type EXPERIMENTAL

Stereotactic Body Radiotherapy (SBRT)

Intervention Type RADIATION

3-5 fractions within 10-14 days

SBRT group B

Escalate the MLD in patients with ≥ 2 lung metastases

Group Type EXPERIMENTAL

Stereotactic Body Radiotherapy (SBRT)

Intervention Type RADIATION

3-5 fractions per tumor within one treatment session or sequential within one month

Interventions

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Stereotactic Body Radiotherapy (SBRT)

3-5 fractions within 10-14 days

Intervention Type RADIATION

Stereotactic Body Radiotherapy (SBRT)

3-5 fractions per tumor within one treatment session or sequential within one month

Intervention Type RADIATION

Other Intervention Names

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Stereotactic Body Radiotherapy Stereotactic Body Radiotherapy

Eligibility Criteria

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Inclusion Criteria

* Weight loss \< 10% in the last three months.
* WHO-performance status ≤ 2
* 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.

Risk group A specification:

Exclusion Criteria

* 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.
* 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.

Risk group B specification:

* Patients with ≥ 2 simultaneous 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.
* Patients having ≥ 2 peripheral lung metastases without unacceptable dose overlap.

* Patients with central tumors
* Pancoast tumors
* Prior radiotherapy treatment to the thorax
* Patients receiving any systemic treatment during SBRT
* Pregnant patients
* Patients previously treated with adriamycin agents in case of heart involvement within the treatment field.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No