Desmoid TumorPhase 2NCT00030680
Radiation Therapy in Treating Patients With Aggressive Fibromatoses
A Phase 2 study testing radiation therapy in people with Desmoid Tumor, run by European Organisation for Research and Treatment of Cancer - EORTC at 21 sites in 7 countries.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients who have aggressive fibromatoses. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Desmoid Tumor
- What is being tested?
- radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 21 sitesin 7 countries
- Study dates
- Nov 2001to Mar 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed aggressive fibromatoses arising in any site
- Primary, recurrent, or progressive disease that is inoperable or requires a major operation resulting in a large functional or cosmetic deficit or mutilation
- Progressive disease defined as at least 20% increase in tumor size on 2 MRI scans within 1 year after any prior therapy except radiotherapy OR
- Incompletely resected tumor with gross residual disease not suitable for further surgery
- Resected within the past 3 months
- Lesions must be suitable for radiotherapy
- No bulky intra-abdominal disease in close relation to small bowel
- Measurable disease
PATIENT CHARACTERISTICS:
Age:
- 16 and over
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- No conditions that would preclude study follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Prior chemotherapy allowed
- No concurrent chemotherapy
Endocrine therapy:
- Prior endocrine therapy allowed
- No concurrent endocrine therapy
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy to indicator lesion
Surgery:
- See Disease Characteristics
- Prior surgery allowed
Other:
- No prior isolated limb perfusion with tumor necrosis factor
- No concurrent isolated limb perfusion with tumor necrosis factor
Trial locations and contacts
21 sites in 7 countries.
21 sites in 7 countries
United Kingdom7 sites
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, B15 2TH
Cookridge Hospital
Leeds, England, LS16 6QB
Christie Hospital
Manchester, England, M20 4BX
Mount Vernon Cancer Centre at Mount Vernon Hospital
Northwood, England, HA6 2RN
Nottingham City Hospital NHS Trust
Nottingham, England, NG5 1PB
Cancer Research Centre at Weston Park Hospital
Sheffield, England, S1O 2SJ
Royal Marsden - Surrey
Sutton, England, SM2 5PT
Netherlands6 sites
Arnhems Radiotherapeutisch Instituut
Arnhem, 6815 AD
University Medical Center Groningen
Groningen, 9700 RB
Leiden University Medical Center
Leiden, 2300 RC
Maastro Clinic - Locatie Maastricht
Maastricht, NL-6229 ET
Daniel Den Hoed Cancer Center at Erasmus Medical Center
Rotterdam, 3008 AE
Dr. Bernard Verbeeten Instituut
Tilburg, 5042 SB
France3 sites
Institut Bergonie
Bordeaux, 33076
Centre Leon Berard
Lyon, 69008
CHU de la Timone
Marseille, 13385
Belgium2 sites
Cliniques Universitaires Saint-Luc
Brussels, 1200
Universitair Ziekenhuis Antwerpen
Edegem, B-2650
Germany1 site
Southwest German Cancer Center at Eberhard-Karls-University
Tübingen, D-72076
Poland1 site
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, 02-781
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, CH-1011
About this study
Official title: Phase II Pilot Study Of Moderate Dose Radiotherapy For Inoperable Aggressive Fibromatoses
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients who have aggressive fibromatoses.
Read the detailed description
OBJECTIVES:
- Determine the efficacy of moderate-dose radiotherapy, in terms of local control, in patients with aggressive fibromatoses.
- Determine the acute and late side-effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive radiotherapy 5 days a week for 5.5 weeks for a total of 56 Gy in 28 fractions.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 3 years.
- Conditions
- Desmoid Tumor
- Being tested
- radiation therapy
- Keywords
- desmoid tumor
- Medical subject headings
- Desmoid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Local control as assessed by MRI at 3 years
Secondary outcomes (2)
Toxicity as assessed by CTC 2.0
Response as assessed by MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startNov 2001
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Desmoid TumorStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- R. B. Keus, MD, Study chair, Arnhems Radiotherapeutisch InstituutThomas Schnabel, MD, Study chair, Klinikum der Stadt Ludwigshafen am Rhein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00030680
- Sponsor's protocol ID
- EORTC-62991-22998
- Other IDs
- EORTC-62991, EORTC-22998
- Status last verified
- Aug 2013
- First submitted
- 14 Feb 2002
- Last updated
- 27 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Pilot Study Of Moderate Dose Radiotherapy For Inoperable Aggressive Fibromatoses
- ClinicalTrials.gov ID
- NCT00030680
- Acronym / sponsor ID
- EORTC-62991-22998
- Conditions
- Desmoid Tumor
- Keywords
- desmoid tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- Nov 2001
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells.
PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients who have aggressive fibromatoses.
Detailed description
OBJECTIVES:
- Determine the efficacy of moderate-dose radiotherapy, in terms of local control, in patients with aggressive fibromatoses.
- Determine the acute and late side-effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive radiotherapy 5 days a week for 5.5 weeks for a total of 56 Gy in 28 fractions.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 3 years.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiation therapy | Radiation | – |
Primary outcome
Local control as assessed by MRI at 3 years
2 secondary outcomes
Toxicity as assessed by CTC 2.0
Response as assessed by MRI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2013.
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FOG-001 in Locally Advanced or Metastatic Solid Tumors
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A Study of a New Drug, Nirogacestat, for Treating Desmoid Tumors That Cannot be Removed by Surgery
Desmoid Fibromatosis, Recurrent Desmoid Fibromatosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
R. B. Keus, MD study chair
Arnhems Radiotherapeutisch Instituut
Thomas Schnabel, MD study chair
Klinikum der Stadt Ludwigshafen am Rhein
21 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing radiation therapy in people with Desmoid Tumor, run by European Organisation for Research and Treatment of Cancer - EORTC at 21 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United Kingdom, Netherlands, France, Belgium, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local control as assessed by MRI at 3 years. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2013.