Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Anticancer Fund, Belgium | OTHER |
| Rising Tide Foundation | OTHER |
Not provided
Not provided
Not provided
Not provided
This is a randomized open-label multicentre Phase III superiority study of the effect of adding SBRT to the standard of care treatment on overall survival in patients with rare oligometastatic cancers.
Patients will be randomized in a 1:1 ratio between current standard of care treatment vs. standard of care treatment + SBRT to all sites of known metastatic disease.
The primary objective of this trial is to assess if the addition of stereotactic body radiotherapy (SBRT) to standard of care treatment improves overall survival (OS) as compared to standard of care treatment alone in patients with rare oligometastatic cancers.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Standard of Care + palliative RT | Active Comparator | 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. |
|
| Arm 2: Standard of Care + SBRT | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic body radiotherapy | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 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. | 7.5 years from first patient in |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | 9 years from first patient in | |
| Disease-specific survival | 9 years from first patient in | |
| Time to disease progression |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| EORTC HQ | Contact | +32 2 7744 1611 | eortc@eortc.org |
| Name | Affiliation | Role |
|---|---|---|
| Matthias Guckenberger | University of Zurich | Principal Investigator |
| Piet Ost | Gasthuiszusters Antwerpen - Sint-Augustinus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Jules Bordet | Recruiting | Anderlecht | 1070 | Belgium | ||
| Universitair Ziekenhuis Gent |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Palliative RT | Radiation | 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). |
|
Disease-specific survival is the time interval from the date of randomization to the date of cancer-related death. |
| 9 years from first patient in |
| Time to development of new metastatic lesions | 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:
| 9 years from first patient in |
| Time to development of polymetastatic disease | 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:
| 9 years from first patient in |
| Adverse events graded according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0 | 9 years from first patient in |
| Health-related quality of life evaluated using self-administered EORTC QLQ-C30 questionnaires | 9 years from first patient in |
| Health-related quality of life evaluated using self-administered EQ-5D-5L questionnaires | 9 years from first patient in |
| Recruiting |
| Ghent |
| 9000 |
| Belgium |
| Gasthuiszusters Antwerpen - Sint-Augustinus | Recruiting | Wilrijk | 2610 | Belgium |
| Centre Oscar Lambret | Recruiting | Lille | 59020 | France |
| Gustave Roussy | Recruiting | Villejuif | 94805 | France |
| Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center | Recruiting | Hamburg | Martinistrasse 52 | DE 20246 | Germany |
| Istituto Europeo di Oncologia | Recruiting | Milan | 20141 | Italy |
| Medical University Of Gdansk | Recruiting | Gdansk | Mariana Smoluchowskiego 17 | PL 80-214 | Poland |
| Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology | Recruiting | Warsaw | PL 02 781 | Poland |
| Inselspital | Recruiting | Bern | 3010 | Switzerland |
| UniversitaetsSpital Zurich | Recruiting | Zurich | 8091 | Switzerland |
| University Hospitals Birmingham NHS Foundation Trust (UHB) - UHB-Queen Elisabeth Medical Centre | Recruiting | Birmingham | B15 2TH | United Kingdom |
| Royal Marsden Hospital - site: Chelsea, London | Recruiting | London | SW3 6JJ | United Kingdom |
| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D012509 | Sarcoma |
| D007680 | Kidney Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D013274 | Stomach Neoplasms |
| D004938 | Esophageal Neoplasms |
| D008545 | Melanoma |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D004067 | Digestive System Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D004935 | Esophageal Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided