ICONIC: Improving Outcomes Through Collaboration in OsteosarComa
キーワード
概要
説明
Osteosarcoma is the most common bone sarcoma, accounting for approximately 30% of all bone sarcoma diagnoses. In England, it accounts for approximately 130 cases per year across all ages.
Generally osteosarcoma has an early peak in adolescent patients, with a second peak in patients over 60 years of age. There are differing treatments, including chemotherapy with more than one drug and surgery to the primary site - and for metastases where these occur.
Outcome, however, has improved little over the past 25 years with the proportion of patients surviving to 5 years remaining at about 42% for all ages and stages in the UK. Patients under 40 years of age (52%) are more likely to survive for 5 years than patients over 40 years (25%).
Survival also depends on the primary site of the osteosarcoma. It is poor for patients with tumours that are not in the limbs, at 36% for patients under the age of 40 years and as low as 6% for patients over 40 years. Also patients with metastatic disease at diagnosis still have a poor outcome.
The use of chemotherapy and surgery depends on factors such as age, the site of the osteosarcoma, how far spread it is and how well the patient is generally, with approximately two thirds of patients currently receiving chemotherapy, radiotherapy and surgery in England each year.
The most recent randomised trial for osteosarcoma, EURAMOS-1 [A randomized trial of the European and American Osteosarcoma Study Group to optimize treatment strategies for resectable osteosarcoma based on histological response to pre-operative chemotherapy], was an excellent example of an international effort to seek improved treatments for a rare cancer. Despite the participation of over 2000 patients, there were no changes to the standard of care for osteosarcoma.
There is still an unmet need to find new approaches, including biomarkers and new, targeted patient specific therapeutic approaches to improve outcomes for this group. This includes searching for improved systemic treatments and better approaches to management of the osteosarcoma. The ICONIC Study will provide a dataset for translational research into osteosarcoma.
Osteosarcoma clinical trials to date have focussed on a limited number of outcomes, usually in the younger patients with a tumour in a limb. So addressing complex inter-related questions has not been possible and several subpopulations of patients have not been studied. This limits opportunities to improve the standard of care. These groups include:
- patients with widely spread (metastatic) disease;
- patients with tumours in the less common locations such as the pelvis, spine and skull;
- patients with osteosarcoma with a background of skeletal abnormalities or an underlying genetic predisposition;
- the 50% of osteosarcoma arising in patients over 40 years.
Little is currently known about factors influencing treatment decisions in these groups and how consistently a standard of care is applied. The effect of treatments on quality of life, patient reported outcomes and other performance assessments is also not well described or understood. As osteosarcoma is quite rare it can be difficult for General Practitioners (GPs) to identify symptoms and patients often wait a long time before tests for osteosarcoma are carried out. How this affects outcomes is not known.
Overall, there is a need to broaden the ambition and scope of osteosarcoma research while improving access for all patients.
日付
最終確認済み: | 10/31/2019 |
最初に提出された: | 07/01/2019 |
提出された推定登録数: | 10/15/2019 |
最初の投稿: | 10/20/2019 |
最終更新が送信されました: | 11/14/2019 |
最終更新日: | 11/18/2019 |
実際の研究開始日: | 10/24/2019 |
一次完了予定日: | 09/30/2022 |
研究完了予定日: | 09/30/2023 |
状態または病気
介入/治療
Other: observational only, no interventions are prescribed in protocol.
段階
適格基準
研究に適格な性別 | All |
サンプリング方法 | Non-Probability Sample |
健康なボランティアを受け入れる | はい |
基準 | Inclusion Criteria: - New histological diagnosis of osteosarcoma or in the absence of osteoid seen on biopsy, pathology and imaging supportive of a diagnosis of osteosarcoma. (It is well recognised that some patients may present with features suggestive of osteosarcoma (under 40 years, radiological abnormality compatible) but in whom no osteoid is detected in needle biopsy. Although categorised as spindle cell tumour of bone, such patients are usually treated in an identical approach to osteosarcoma. A definite diagnosis of osteosarcoma is then often possible after surgery when the entire resection specimen is available.) - Written informed consent of patient and/or parent/legal guardian. Exclusion Criteria: • Diagnosis more than three months prior to registration. |
結果
主な結果の測定
1. Feasibility phase: Patient recruitment. [One year from study opening.]
2. Main Study: Patient recruitment [3 years from study opening.]
二次的な結果の測定
1. Correlation of chemotherapy and radiotherapy to outcome [4 years from registration.]
2. Do tumour margin and response to chemotherapy predict local recurrence in OS? [4 years from registration.]
3. Correlation of tumour heterogeneity and clonal evolution to chemotherapy response and patient outcome. [4 years from registration.]
4. Validation of whole genome sequencing [4 years from registration.]
5. Analysis of circulating biomarkers [4 years from registration.]
6. Patient reported outcomes [4 years from registration.]