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Stereotactic Body Radiotherapy in Patients With Rare Oligometastatic Cancers (OligoRARE) (OligoRARE)

Primary Purpose

Gynecologic Cancer, Skin Cancer, Head and Neck Cancer

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Stereotactic body radiotherapy

Palliative RT

About this trial

This is an interventional treatment trial for Gynecologic Cancer focused on measuring oligometastatic cancer, Stereotactic body radiotherapy, SBRT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
Controlled primary tumour, defined as:
at least 3 months since original tumour treated definitively, with no progression at primary site
Total number of oligometastases of 1-5 including:
Brain metastases amenable to radiosurgery or fractionated stereotactic radiotherapy patient who had neurosurgical resection before trial inclusion are allowed and resected brain metastases count to the total number of oligometastases
All sites of disease can be safely treated based on the judgement of an experienced radiation oncologist
ECOG score 0-2
Life expectancy > 6 months
Age 18 or older
Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.

Exclusion Criteria:

Primary cancer of prostate, breast, lung or colorectal
Serious medical comorbidities precluding radiotherapy:
These include interstitial lung disease in patients requiring thoracic radiation, Crohn's disease in patients where the GI tract will receive radiotherapy, or ulcerative colitis where the bowel will receive radiotherapy and connective tissue disorders such as lupus or scleroderma.
For patients with liver metastases, moderate/severe liver dysfunction (Child Pugh B or C)
Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints herein. For patients treated previously with radiation, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed in the RTQA Guidelines. All such cases should be discussed with one of the study coordinators
Brain metastases only, without extra-cerebral metastases
Malignant pleural effusion, malignant ascites, meningeal carcinomatosis and peritoneal carcinomatosis
Maximum size of 6 cm for lesions outside the brain, except:
Bone metastases over 5 cm may be included, if in the opinion of the local radiation oncologist it can be treated safely (e.g. rib, scapula, pelvis)
Clinical or radiologic evidence of symptomatic spinal cord compression. Patients can be eligible if surgical resection has been performed, but the surgical site counts toward the total of up to 3 metastases.
Metastatic disease that invades any of the following: GI tract (including oesophagus, stomach, small or large bowel), mesenteric lymph nodes, or disseminated skin metastases and lymphangiosis
Pregnant or breast feeding women
Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial

Sites / Locations

Universitair Ziekenhuis GentRecruiting
Gasthuiszusters Antwerpen - Sint-AugustinusRecruiting
Centre Oscar LambretRecruiting
Gustave RoussyRecruiting
Istituto Europeo di OncologiaRecruiting
InselspitalRecruiting
UniversitaetsSpital ZurichRecruiting
University Hospitals Birmingham NHS Foundation Trust (UHB) - UHB-Queen Elisabeth Medical Centre
Royal Marsden Hospital - site: Chelsea, London

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm 1: Standard of Care + palliative RT

Arm 2: Standard of Care + SBRT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Progression-free survival

Disease-specific survival

Time to disease progression

Disease-specific survival is the time interval from the date of randomization to the date of cancer-related death.

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: Development new metastatic lesions, Cancer-related death.

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: 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.

Adverse events graded according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0

Health-related quality of life evaluated using self-administered EORTC QLQ-C30 questionnaires

Health-related quality of life evaluated using self-administered EQ-5D-5L questionnaires

Full Information

NCT ID

NCT04498767

First Posted

July 30, 2020

Last Updated

April 14, 2023

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

Anticancer Fund, Belgium, Rising Tide Foundation

1. Study Identification

Unique Protocol Identification Number

NCT04498767

Brief Title

Stereotactic Body Radiotherapy in Patients With Rare Oligometastatic Cancers (OligoRARE)

Acronym

OligoRARE

Official Title

Stereotactic Body Radiotherapy in Addition to Standard of Care Treatment in Patients With Rare Oligometastatic Cancers (OligoRARE): a Randomized, Phase 3, Open-label Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 10, 2021 (Actual)

Primary Completion Date

August 1, 2028 (Anticipated)

Study Completion Date

February 1, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

Anticancer Fund, Belgium, Rising Tide Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gynecologic Cancer, Skin Cancer, Head and Neck Cancer, Sarcoma, Renal Cancer, Bladder Cancer, Upper Urinary Tract Carcinoma, Pancreatic Cancer, Hepatobiliary Cancer, Gastric Cancer, Small Bowel Cancer, Esophageal Cancer, Melanoma, Colon Cancer, Oligometastasis

Keywords

oligometastatic cancer, Stereotactic body radiotherapy, SBRT

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm 1: Standard of Care + palliative RT

Arm Type

Active Comparator

Arm Description

Arm Title

Arm 2: Standard of Care + SBRT

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

Stereotactic body radiotherapy

Other Intervention Name(s)

SBRT

Intervention Description

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.

Intervention Type

Radiation

Intervention Name(s)

Palliative RT

Intervention Description

Primary Outcome Measure Information:

Title

Overall survival

Description

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.

Time Frame

7.5 years from first patient in

Secondary Outcome Measure Information:

Title

Progression-free survival

Time Frame

9 years from first patient in

Title

Disease-specific survival

Time Frame

9 years from first patient in

Title

Time to disease progression

Description

Disease-specific survival is the time interval from the date of randomization to the date of cancer-related death.

Time Frame

9 years from first patient in

Title

Time to development of new metastatic lesions

Description

Time Frame

9 years from first patient in

Title

Time to development of polymetastatic disease

Description

Time Frame

9 years from first patient in

Title

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

Title

Health-related quality of life evaluated using self-administered EORTC QLQ-C30 questionnaires

Time Frame

9 years from first patient in

Title

Health-related quality of life evaluated using self-administered EQ-5D-5L questionnaires

Time Frame

9 years from first patient in

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required. Controlled primary tumour, defined as: at least 3 months since original tumour treated definitively, with no progression at primary site Total number of oligometastases of 1-5 including: Brain metastases amenable to radiosurgery or fractionated stereotactic radiotherapy patient who had neurosurgical resection before trial inclusion are allowed and resected brain metastases count to the total number of oligometastases All sites of disease can be safely treated based on the judgement of an experienced radiation oncologist ECOG score 0-2 Life expectancy > 6 months Age 18 or older Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations. Exclusion Criteria: Primary cancer of prostate, breast, lung or colorectal Serious medical comorbidities precluding radiotherapy: These include interstitial lung disease in patients requiring thoracic radiation, Crohn's disease in patients where the GI tract will receive radiotherapy, or ulcerative colitis where the bowel will receive radiotherapy and connective tissue disorders such as lupus or scleroderma. For patients with liver metastases, moderate/severe liver dysfunction (Child Pugh B or C) Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints herein. For patients treated previously with radiation, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed in the RTQA Guidelines. All such cases should be discussed with one of the study coordinators Brain metastases only, without extra-cerebral metastases Malignant pleural effusion, malignant ascites, meningeal carcinomatosis and peritoneal carcinomatosis Maximum size of 6 cm for lesions outside the brain, except: Bone metastases over 5 cm may be included, if in the opinion of the local radiation oncologist it can be treated safely (e.g. rib, scapula, pelvis) Clinical or radiologic evidence of symptomatic spinal cord compression. Patients can be eligible if surgical resection has been performed, but the surgical site counts toward the total of up to 3 metastases. Metastatic disease that invades any of the following: GI tract (including oesophagus, stomach, small or large bowel), mesenteric lymph nodes, or disseminated skin metastases and lymphangiosis Pregnant or breast feeding women Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

EORTC HQ

Phone

+32 2 7744 1611

eortc@eortc.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matthias Guckenberger

Organizational Affiliation

University of Zurich

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Piet Ost

Organizational Affiliation

Gasthuiszusters Antwerpen - Sint-Augustinus

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universitair Ziekenhuis Gent

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pieter Deseyne, MD

First Name & Middle Initial & Last Name & Degree

Pieter Deseyne, MD

Facility Name

Gasthuiszusters Antwerpen - Sint-Augustinus

City

Wilrijk

ZIP/Postal Code

2610

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Piet Ost, MD

First Name & Middle Initial & Last Name & Degree

Piet Ost, MD

Facility Name

Centre Oscar Lambret

City

Lille

ZIP/Postal Code

59020

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Pasquier, MD

First Name & Middle Initial & Last Name & Degree

David Pasquier, MD

Facility Name

Gustave Roussy

City

Villejuif

ZIP/Postal Code

94805

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Antonin Levy, MD

First Name & Middle Initial & Last Name & Degree

Antonin Levy, MD

Facility Name

Istituto Europeo di Oncologia

City

Milano

ZIP/Postal Code

20141

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Daniela Alterio, MD

First Name & Middle Initial & Last Name & Degree

Daniela Alterio, MD

Facility Name

Inselspital

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hossein Hemmatazad, MD

First Name & Middle Initial & Last Name & Degree

Hossein Hemmatazad, MD

Facility Name

UniversitaetsSpital Zurich

City

Zurich

ZIP/Postal Code

8091

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Matthias Guckenberger, MD

First Name & Middle Initial & Last Name & Degree

Matthias Guckenberger, MD

Facility Name

University Hospitals Birmingham NHS Foundation Trust (UHB) - UHB-Queen Elisabeth Medical Centre

City

Birmingham

ZIP/Postal Code

B15 2TH

Country

United Kingdom

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jennifer Sherriff, MD

First Name & Middle Initial & Last Name & Degree

Jennifer Sherriff, MD

Facility Name

Royal Marsden Hospital - site: Chelsea, London

City

London

ZIP/Postal Code

SW3 6JJ

Country

United Kingdom

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shane Zaidi, MD

12. IPD Sharing Statement

Learn more about this trial

Stereotactic Body Radiotherapy in Patients With Rare Oligometastatic Cancers (OligoRARE)

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