Long-term Effects Secondary to Cancer Therapy in ChildrenPhase 2NCT00416559
Observation of Young Patients With Localized Neuroblastoma Who Have Undergone Surgery Only
A Phase 2 study testing clinical observation in people with Long-term Effects Secondary to Cancer Therapy in Children and Neuroblastoma, run by Children's Cancer and Leukaemia Group.
Trial summary
RATIONALE: Observation is closely monitoring a patient's condition and not giving treatment until symptoms appear or change. Observation may help doctors see how effective surgery is in treating neuroblastoma. Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Long-term Effects Secondary to Cancer Therapy in Children, Neuroblastoma
- What is being tested?
- clinical observation
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to not given
- 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 Up to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
DISEASE CHARACTERISTICS:
- Histologically confirmed neuroblastoma or ganglioneuroblastoma
- Meets 1 of the following International Neuroblastoma Staging System (INSS) criteria:
- Stage 1
- Stage 2A or 2B meeting 1 of the following criteria:
- With or without N-myc amplification
- No evaluation of NMA
- Symptomatic spinal cord compression
- Stage 3*
- Dumbbell syndrome with clinical signs of spinal cord compression*
- NOTE: *These patients are eligible for the study but do not undergo observation; instead they will undergo standard treatment
- Has undergone complete or gross surgical resection OR diagnostic surgical or needle biopsy
- No metastases within 1 month of diagnosis
- No skin metastases by clinical examination and MIBG scan
- Normal liver by CT scan or ultrasonography
- Normal chest X-ray (in case of nonthoracic primary site)
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior steroids allowed
- No prior chemotherapy
About this study
Official title: Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma
RATIONALE: Observation is closely monitoring a patient's condition and not giving treatment until symptoms appear or change. Observation may help doctors see how effective surgery is in treating neuroblastoma.
PURPOSE: This phase II trial is studying how well surgery alone works in treating young patients with localized neuroblastoma.
Read the detailed description
OBJECTIVES:
Primary
- Evaluate the safety and efficacy of surgical treatment alone in young patients with stage 2 neuroblastoma without N-myc amplification (NMA).
Secondary
- Determine predictive factors of relapse and survival of patients with stage 1, 2A, or 2B neuroblastoma without NMA who have undergone surgery only.
OUTLINE: This is a nonrandomized, multicenter study.
Patients with stage 1 or 2 disease and no N-myc amplification (NMA) undergo observation comprising clinical evaluation, ultrasound or CT scan of the abdomen, and chest x-ray periodically for up to 5 years. All other patients undergo additional therapy and follow-up according to national standards. Patients who develop recurrent disease or disease progression may undergo surgical resection, preceded or followed by chemotherapy, according to national standards.
PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study.
- Being tested
- clinical observation
- Keywords
- long-term effects secondary to cancer therapy in children, localized resectable neuroblastoma, localized unresectable neuroblastoma, regional neuroblastoma
- Medical subject headings
- Neuroblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical observationOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy
Secondary outcomes (1)
Predictive factors of relapse and survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2006 (estimated)
- Study startDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long-term Effects Secondary to Cancer Therapy in ChildrenStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Cancer and Leukaemia Group
- Sponsor type
- University, hospital or other
- Investigators
- Bruno De Bernardi, MD, Study chair, Istituto Giannina GasliniJean Marie Michon, MD, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416559
- Sponsor's protocol ID
- CDR0000454574
- Other IDs
- CCLG-NB-1995-06, EU-20596, CCLG-94-01
- Status last verified
- May 2007
- First submitted
- 27 Dec 2006
- Last updated
- 20 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Surgery as the Only Treatment for INSS Stage 2A & 2B Neuroblastoma
- ClinicalTrials.gov ID
- NCT00416559
- Acronym / sponsor ID
- CDR0000454574
- Keywords
- long-term effects secondary to cancer therapy in children, localized resectable neuroblastoma, localized unresectable neuroblastoma, regional neuroblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Children's Cancer and Leukaemia GroupUniversity, hospital or other
- Study start
- Dec 2004
- First posted
- 28 Dec 2006 (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: Observation is closely monitoring a patient's condition and not giving treatment until symptoms appear or change. Observation may help doctors see how effective surgery is in treating neuroblastoma.
PURPOSE: This phase II trial is studying how well surgery alone works in treating young patients with localized neuroblastoma.
Detailed description
OBJECTIVES:
Primary
- Evaluate the safety and efficacy of surgical treatment alone in young patients with stage 2 neuroblastoma without N-myc amplification (NMA).
Secondary
- Determine predictive factors of relapse and survival of patients with stage 1, 2A, or 2B neuroblastoma without NMA who have undergone surgery only.
OUTLINE: This is a nonrandomized, multicenter study.
Patients with stage 1 or 2 disease and no N-myc amplification (NMA) undergo observation comprising clinical evaluation, ultrasound or CT scan of the abdomen, and chest x-ray periodically for up to 5 years. All other patients undergo additional therapy and follow-up according to national standards. Patients who develop recurrent disease or disease progression may undergo surgical resection, preceded or followed by chemotherapy, according to national standards.
PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| clinical observation | Other | – |
Primary outcome
Safety and efficacy
1 secondary outcome
Predictive factors of relapse and survival
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
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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.
Bruno De Bernardi, MD study chair
Istituto Giannina Gaslini
Jean Marie Michon, MD
Institut Curie
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing clinical observation in people with Long-term Effects Secondary to Cancer Therapy in Children and Neuroblastoma, run by Children's Cancer and Leukaemia Group.
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: status not confirmed, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Safety and efficacy. 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 20 Sep 2013.