CASPS
Research type
Research Study
Full title
A Phase II Trial of Cediranib in the Treatment of Patients with Alveolar Soft Part Sarcoma (CASPS).
IRAS ID
60384
Contact name
Ian Judson
Sponsor organisation
The Institute of Cancer Research
Eudract number
2010-021163-33
ISRCTN Number
N/A
Research summary
Alveolar soft part sarcoma (ASPS) is a cancer found in soft tissue, usually in the limbs, head and neck of young adults. ASPS is very rare, with an estimated incidence of 15 cases per year in the UK. The disease spreads to other parts of the body (metastasises) at a high rate, but often then becomes dormant meaning patients can survive for more than 3 years with metastatic (advanced) disease.Standard chemotherapy shows no benefit in ASPS patients and there is no alternative standard accepted treatment.Cediranib is the drug under investigation. It works by blocking the action of a growth factor called Vascular Endothelial Growth Factor (VEGF). VEGF encourages the formation of new blood vessels in the body. As tumours need a blood supply in order to grow, stopping VEGF from working may slow tumour growth and therefore disease progression in ASPS. The CASPS study aims to investigate the role of cediranib in patients with metastatic ASPS. The primary objective of the trial is to compare the size of patients tumours after 24 weeks of cediranib treatment, compared to treatment with a placebo. Treatment allocation will be randomly assigned and neither doctor or patient will know which treatment is being received. Two patients will receive cediranib, for every one patient receiving placebo.At 24 weeks, patients taking placebo can start cediranib treatment and patients already receiving cediranib can continue treatment. All patients continue to take cediranib until their clinician judges they are no longer benefitting ie. their disease gets worse (progression). Patients will undergo routine safety assessments and have regular scans to assess how their disease is responding.Male or female patients, age 16 and over with ASPS which has progressed in the last 6 months are eligible. The trial will be conducted in NHS centres across the UK, and internationally.
Lay Summary of Results
Clinical trial for a Rare Cancer – CASPS Trial
Doctors ran a study called the CASPS trial to test a new medicine called cediranib. They wanted to see if it could help people with a very rare cancer called Alveolar Soft Part
Sarcoma (ASPS) which particularly affects young people. Cancers needs new blood vessels to grow and spread in the body. Cediranib works by stopping new blood vessels
from growing.
• The trial took place in hospitals in the UK, Australia, and Spain.
• Forty-eight patients suffering with this cancer joined the trial. 23 were men and
25 were women, in the age group of 20-29 years.
• In the first part of the trial, some patients took cediranib, while others took a placebo. Placebo is a fake tablet that looks the same but doesn’t have any medicine.
• Patients had a 2 out of 3 chance of getting cediranib and a 1 out of 3 chance of getting the placebo.
• The groups were chosen randomly by a computer, like flipping a coin. This was fair. Neither the patients nor the doctors knew which treatment was being given during the first part of the trial.
After 24 weeks, in the second part of the trial all the patients were allowed to take cediranib.
The study found that patients who took cediranib in the first 24 weeks had more tumour shrinkage than those who took the placebo. It also took longer before their tumours
started growing again. Doctors also looked at how long patients lived with their cancer before it got worse. This was hard to measure because everyone eventually took cediranib.
The medicine did have side effects. Some people felt sick, had diarrhoea, high blood pressure, or felt very tired. Twelve people had serious side effects, and one person had a stroke caused by high blood pressure. This showed that blood pressure needs to be watched closely for anyone taking cediranib.
The CASPS trial showed that cediranib can help patients with ASPS. It could become an important treatment for this rare type of cancer in the future.
Has the registry been updated to include summary results?: Yes
If yes - please enter the URL to summary results: file:///C:/Users/ssirohi01/Downloads/ISRCTN63733470_ResultsPlainEnglish_24Jan25%20(8).pdf
If no – why not?:
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
If yes, describe or provide URLs to disseminated materials: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fpubmed.ncbi.nlm.nih.gov%252F31160249%252F%2FNBTI%2FeaO7AQ%2FAQ%2Fa11b3055-dc92-41d3-9a86-bbbd7f6dba36%2F2%2FTlSvBkR1e1&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C963046a6ffec4f290c9008dd5659da97%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638761666105186906%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=v0QgMsAGYalmYL8VmUJFr2eqoDpgc8oFj5LI82y520Y%3D&reserved=0https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.isrctn.com%252FISRCTN63733470%253Fq%253DCASPS%2526filters%253D%2526sort%253D%2526offset%253D1%2526totalResults%253D1%2526page%253D1%2526pageSize%253D10%2FNBTI%2FeaO7AQ%2FAQ%2Fa11b3055-dc92-41d3-9a86-bbbd7f6dba36%2F3%2FvMAGUWVwn_&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7C963046a6ffec4f290c9008dd5659da97%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638761666105201924%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=OtbkCPzfw3q2KQCSjzFbZSAPyw2mPOOh%2Bp7EiKzAgkg%3D&reserved=0
If pending, date when dissemination is expected:
If no, explain why you didn't follow it:
Have participants been informed of the results of the study?: Yes
If yes, describe and/or provide URLs to materials shared and how they were shared: A lay summary of results and covering letters notifying the participants and/or relatives, of trial closure (approved by Ethics on 4th Mar 2021) was disseminated to the participating sites-who were asked to provide these documents to the patients and/or relatives at their discretion as per their local standard procedures for communicating with patients. The sites were reminded to only send the summary and covering letter to patients who were known to be alive and well enough to receive such a communication.
If pending, date when feedback is expected:
If no, explain why they haven't:
Have you enabled sharing of study data with others?: Yes
If yes, describe or provide URLs to how it has been shared: No specific data access requests have been received to date. Any request for such access will be reviewed in accordance with ICR-CTSU's data and sample access policy.
If no, explain why sharing hasn't been enabled:
Have you enabled sharing of tissue samples and associated data with others?: Yes
If yes, describe or provide a URL: No specific data access requests have been received to date. Any request for such access will be reviewed in accordance with ICR-CTSU's data and sample access policy.
If no, explain why:REC name
London - Surrey Borders Research Ethics Committee
REC reference
10/H0806/118
Date of REC Opinion
18 Feb 2011
REC opinion
Further Information Favourable Opinion