1. Overall survival (Time Frame - 7.5 years from first patient in): Overall survival is the time interval from the date of randomization to the date of death whatever the cause of death. Patients who are alive are censored at the last date known to be alive.
Secondary outcome:
1. Progression-free survival (Time Frame - 9 years from first patient in)
2. Disease-specific survival (Time Frame - 9 years from first patient in)
3. Time to disease progression (Time Frame - 9 years from first patient in): Disease-specific survival is the time interval from the date of randomization to the date of cancer-related death.
4. Time to development of new metastatic lesions (Time Frame - 9 years from first patient in): Time to development of new metastatic lesions is the time interval from the date of randomization to the date of first occurrence of any of the following events:
Development new metastatic lesions,
Cancer-related death.
5. Time to development of polymetastatic disease (Time Frame - 9 years from first patient in): Time to development of polymetastatic disease is the time interval from the date of randomization to the date of first occurrence of any of the following events:
Presence of more than 5 metastases at a specific timepoint during follow-up,
Development of metastases that preclude treatment with SBRT (e.g. due to large size or locating in previously irradiated region where re-irradiation is not possible),
Cancer-related death.
6. Adverse events graded according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0 (Time Frame - 9 years from first patient in)
7. Health-related quality of life evaluated using self-administered EORTC QLQ-C30 questionnaires (Time Frame - 9 years from first patient in)
8. Health-related quality of life evaluated using self-administered EQ-5D-5L questionnaires (Time Frame - 9 years from first patient in)
Active Comparator: Arm 1: Standard of Care + palliative RT Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications. Recommended dose fractionations in this arm will include 8 Gy in 1 fractions, 20 Gy in 5 fractions, and 30 Gy in 10 fractions. Patients in this arm should not receive stereotactic doses or radiotherapy boosts, unless there is a clearly known clinical benefit (e.g. stereotactic radiation to a new brain metastases when all disease is controlled on systemic therapy).
Systemic therapy will be pre-specified based on the standard of care approach for that patient, and it may include cytotoxic, targeted, hormonal, or immunotherapy.
Experimental: Arm 2: Standard of Care + SBRT The experimental arm consists of SBRT (and standard of care systemic therapy). Each lesion may be treated with 1, 3, or 5 SBRT fractions of 16-24 Gy, 24-33 Gy or 25-40 Gy, respectively, depending on the local practice and size & location of oligometastases. Three-fraction regimens will deliver a fraction every second day, and five-fraction regimens are delivered daily. All treatments must be completed within 2 weeks (10 working days) in order to avoid delays in starting systemic therapy.
Patients treated with prior or concomitant systemic therapy are eligible for this study. Use of chemotherapy regimens, targeted therapy or immunotherapy containing potent enhancers of radiation damage (e.g. gemcitabine, doxorubicin) can be postponed or interrupted for a duration of one month after radiation.
Stereotactic body radiotherapy (SBRT): Each lesion may be treated with 1, 3, or 5 SBRT fractions of 16-24 Gy, 24-33 Gy or 25-40 Gy, respectively, depending on the local practice and size & location of oligometastases. Three-fraction regimens will deliver a fraction every second day, and five-fraction regimens are delivered daily. All treatments must be completed within 2 weeks (10 working days) in order to avoid delays in starting systemic therapy.
Palliative RT: Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications. Recommended dose fractionations in this arm will include 8 Gy in 1 fractions, 20 Gy in 5 fractions, and 30 Gy in 10 fractions. Patients in this arm should not receive stereotactic doses or radiotherapy boosts, unless there is a clearly known clinical benefit (e.g. stereotactic radiation to a new brain metastases when all disease is controlled on systemic therapy).
Quelle: ClinicalTrials.gov
Sie können folgenden Inhalt einem Kollegen empfehlen:
"Stereotactic Body Radiotherapy in Patients With Rare Oligometastatic Cancers (OligoRARE)"
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