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

Not Applicable

Recruiting

• Conditions: Gynecologic Cancer; Skin Cancer; Pancreatic Cancer; Hepatobiliary Cancer; Head and Neck Cancer; Sarcoma; Renal Cancer; Bladder Cancer; Upper Urinary Tract Carcinoma; Gastric Cancer

• Registration Number: NCT04498767
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-7-30
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival

Secondary Outcome Measures

Name	Time	Method
Progression-free survival;Disease-specific survival;Time to disease progression;Time to development of new metastatic lesions;Time to development of polymetastatic disease;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