Childhood Favorable Prognosis Hodgkin LymphomaPhase 3NCT00302003

Combination Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Lymphoma

A Phase 3 study testing radiation therapy, doxorubicin hydrochloride and vincristine sulfate in people with Childhood Favorable Prognosis Hodgkin Lymphoma and Childhood Lymphocyte Depletion Hodgkin Lymphoma, run by Children's Oncology Group at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages Up to 21 years
Conditions the study is for: Childhood Favorable Prognosis Hodgkin Lymphoma, Childhood Lymphocyte Depletion Hodgkin Lymphoma, Childhood Mixed Cellularity Hodgkin Lymphoma
What is being tested?: radiation therapy, doxorubicin hydrochloride and vincristine sulfate
Type of treatment: Pill or oral medicine, Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 287 participants
Where: 1 siteUnited States
Study dates: Feb 2006to 30 Jun 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Histologically confirmed Hodgkin's lymphoma meeting the following criteria:
Newly diagnosed disease
Stage IA OR stage IIA without bulky disease
No lymphocyte-predominant histology
Staging on this study will be determined by the clinical stage; surgical staging is strongly discouraged, except for the rare situation of equivocal imaging studies below the diaphragm
Patients may not have received any previous chemotherapy or radiation therapy; patients may not have received systemic corticosteroids within 30 days of enrollment on this protocol; steroids used for treatment of contrast agent allergy required for computed tomography (CT) scans are acceptable

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Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^3
Total bilirubin =< 1.5 x normal
Alanine (ALT) =< 2.5 x normal
Shortening fraction >= 27% by echocardiogram OR ejection fraction >= 50% by multi-gated acquisition (MUGA)
No pathologic prolongation of QTc interval on 12-lead electrocardiography (ECG)
Female patients of childbearing potential must have a negative pregnancy test
Lactating females must agree that they will not breastfeed a child while on this study
Fertile patients must use effective contraception
Males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
All patients and/or their parents or legal guardians must sign a written informed consent
All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Oncology Group
Arcadia, California, 91006-3776

Other trials in United States

About this study

Official title: A Phase III Study for the Treatment of Children and Adolescents With Newly Diagnosed Low Risk Hodgkin Disease

This phase III trial is studying how well combination chemotherapy works when given before radiation therapy and/or additional chemotherapy in treating young patients with newly diagnosed Hodgkin's lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving more than one drug (combination chemotherapy) and giving them together with radiation therapy may kill more cancer cells.

Read the detailed description

OBJECTIVES:

Investigate the paradigm of response-based therapy for low-risk Hodgkin's lymphoma by eliminating involved-field radiotherapy (IFRT) in patients who achieve a complete remission (CR) after initial chemotherapy.

II. Investigate whether 3 courses of doxorubicin hydrochloride, vincristine, prednisone, and cyclophosphamide (AV-PC) for the treatment of low-risk Hodgkin's lymphoma is sufficient to induce CR in at least 80% of patients.

III. Investigate whether patients who experience a low-risk relapse after initial treatment with chemotherapy alone can be successfully treated with a salvage regimen comprising ifosfamide and vinorelbine ditartrate with dexamethasone, etoposide phosphate, cisplatin, and cytarabine (IV/DECA) and IFRT.

IV. Maintain the overall survival for patients with low-risk Hodgkin's lymphoma at or above 97%.

Determine the prognostic significance of very early response as measured by fludeoxyglucose-positron emission tomography (FDG-PET) or gallium after the first course of chemotherapy.

VI. Evaluate the prognostic significance of elevation of erythrocyte sedimentation rate and C-reactive protein at the time of diagnosis in patients with low-risk Hodgkin's lymphoma on CR rate and relapse rate after chemotherapy alone.

VII. Determine the frequency and severity of late effects of therapy, including thyroid dysfunction, infertility, cardiotoxicity, and second malignant neoplasms.

OUTLINE: This is a multicenter study.

INITIAL CHEMOTHERAPY: Patients receive doxorubicin hydrochloride intravenously (IV) over 10-30 minutes and cyclophosphamide IV over 1 hour on days 1-2, vincristine IV on days 1 and 8, prednisone orally (PO) on days 1-7, and filgrastim (G-CSF) subcutaneously (SC) on days 3-7 and 9-14. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Patients achieving complete remission (CR) proceed to observation. Patients achieving partial remission proceed to radiotherapy. Patients who have a low-risk relapse after achieving CR on initial chemotherapy proceed to salvage chemotherapy followed by radiotherapy. Patients who have stable disease or disease progression go off study.

SALVAGE CHEMOTHERAPY: Patients receive ifosfamide IV continuously on days 1-4, vinorelbine ditartrate IV over 6-10 minutes on days 1-5, and G-CSF SC or IV beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses. Patients then receive dexamethasone IV over 15 minutes every 12 hours, etoposide phosphate IV over 3 hours every 12 hours, and cytarabine IV over 3 hours every 12 hours on days 1 and 2; cisplatin IV over 6 hours on day 1; and G-CSF SC or IV beginning on day 3 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses. Patients then proceed to radiotherapy.

INVOLVED-FIELD RADIOTHERAPY (IFRT): Beginning 4 weeks after completion of chemotherapy, patients undergo IFRT once daily, 5 days a week, for 2.8 weeks. Patients who do not achieve CR go off study.

After completion of study treatment, patients are followed periodically for up to 10 years.

Conditions: Childhood Favorable Prognosis Hodgkin Lymphoma, Childhood Lymphocyte Depletion Hodgkin Lymphoma, Childhood Mixed Cellularity Hodgkin Lymphoma, Childhood Nodular Sclerosis Hodgkin Lymphoma, Stage I Childhood Hodgkin Lymphoma, Stage II Childhood Hodgkin Lymphoma
Being tested: radiation therapy, doxorubicin hydrochloride, vincristine sulfate, prednisone, cyclophosphamide
Medical subject headings: Hodgkin Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

radiation therapyRadiation
Also called irradiation, radiotherapy, therapy, radiation
Undergo radiation therapy
doxorubicin hydrochlorideDrug
Also called ADM, ADR, Adria, Adriamycin PFS
Given IV
vincristine sulfateDrug
Also called leurocristine sulfate, VCR, Vincasar PFS
Given IV
prednisoneDrug
Also called DeCortin, Deltra
Given orally
cyclophosphamideDrug
Also called CPM, CTX, Cytoxan, Endoxan
Given IV
ifosfamideDrug
Also called Cyfos, Holoxan, IFF, IFX
Given IV
vinorelbine tartrateDrug
Also called Eunades, navelbine ditartrate, NVB, VNB
Given IV
dexamethasoneDrug
Also called Aeroseb-Dex, Decaderm, Decadron, DM
Given IV
etoposide phosphateDrug
Also called ETOP, Etopophos
Given IV
cisplatinDrug
Also called CACP, CDDP, CPDD, DDP
Given IV
cytarabineDrug
Also called ARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-U
Given IV
filgrastimBiological
Also called G-CSF, Neupogen
Given IV or subcutaneously

Study groups in NCT00302003
Study group	Role	What they receive
Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim	Experimental	Treatment consists of 3 cycles of Doxorubicin hydrochloride IV (25 mg/m2) days 1 \& 2, Vincristine sulfate IV (1.4 mg/m2 [max 2.8 mg]) Days 1 \& 8, Prednisone orally (40 mg/m2) Days 1-7, Cyclophosphamide IV (600 mg/m2) Days 1 \& 2, Filgrastim by mouth or IV (5 micrograms/kg/dose) 24 hours after Cyclophosphamide complete. See detailed description for remainder of therapy. Receives: Radiation: radiation therapy; Drug: doxorubicin hydrochloride; Drug: vincristine sulfate; Drug: prednisone; Drug: cyclophosphamide; Drug: ifosfamide; Drug: vinorelbine tartrate; Drug: dexamethasone; Drug: etoposide phosphate; Drug: cisplatin; Drug: cytarabine; Biological: filgrastim

What is being measured

The primary outcome is the main question the study is designed to answer.

Event Free Survival Without Receiving Radiation Therapy (EFSnoRT).
Survival is defined as the minimum time from study entry to requirement for additional chemotherapy and IFRT for retrieval, occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact. Patients who achieve less than CR after 3 cycles of AV-PC will require IFRT and hence will satisfy this definition at the time of response evaluation. Patients who achieve a CR but who relapse will receive addition chemotherapy and IFRT or intense retrieval and hence will satisfy this definition at the time of the first relapse of Hodgkin disease. This endpoint will be used to compute event free survival without receiving radiation therapy (EFSnoRT).
Measured: At 60 months
Intensive Therapy Free Survival (ITFS).
Survival is defined as the minimum time from study entry to a relapse of higher risk at any time, any relapse following treatment with protocol mandated IFRT, death from any cause, or the occurrence of a second malignant neoplasm. This will be used to compute intensive therapy free survival (ITFS). Patients without report of such events where censored at last contact. This differs from traditional EFS in that relapse after AVPC* x3 therapy alone that does not place the patient in a higher risk category is not considered a treatment failure. In this definition, higher-risk relapse refers to relapse involving sites and extent of disease that place the patient in the current COG definition of intermediate or high-risk disease. If a patient with CR who experiences a LR relapse is not retreated with protocol-mandated chemotherapy and IFRT, subsequent disease relapses will nevertheless be counted in the analysis of the treatment strategy.
Measured: At 60 months
Event Free Survival (EFS)
Survival is defined as the minimum time from study entry to a relapse of any kind, death from any cause, or occurrence of a second malignant neoplasm. Patients without report of such events where censored at last contact. This will be used to compute event free survival (EFS).
Measured: At 60 months

Secondary outcomes (1)

Overall Survival
Survival is defined as time from study entry to death due to any cause. Patients alive at last contact where censored at last contact.
Measured: At 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 200630 Jun 2019

First posted13 Mar 2006 (estimated)
Study startFeb 2006
Primary completionMar 2012
Study completion30 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Childhood Favorable Prognosis Hodgkin LymphomaStudies of the same condition, open and under way.
More trials run by Children's Oncology GroupThe 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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 287 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00302003
Sponsor's protocol ID: AHOD0431
Other IDs: NCI-2009-00377, CDR0000459962, U10CA098543, COG-AHOD0431
Status last verified: Aug 2016
First submitted: 9 Mar 2006
Last updated: 30 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Castellino SM, Giulino-Roth L, Harker-Murray P, Kahn JM, Forlenza C, Cho S, Hoppe B, Parsons SK, Kelly KM; COG Hodgkin Lymphoma Committee. Children's Oncology Group's 2023 blueprint for research: Hodgkin lymphoma. Pediatr Blood Cancer. 2023 Sep;70 Suppl 6(Suppl 6):e30580. doi: 10.1002/pbc.30580. Epub 2023 Jul 28.
PubMed 37505794
Parekh A, Keller FG, McCarten KM, Kessel S, Cho S, Pei Q, Wu Y, Castellino SM, Constine LS, Schwartz CL, Hodgson D, Kelly KM, Hoppe BS. Targeted radiotherapy for early-stage, low-risk pediatric Hodgkin lymphoma slow early responders: a COG AHOD0431 analysis. Blood. 2022 Sep 8;140(10):1086-1093. doi: 10.1182/blood.2022016098.
PubMed 35763667

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Study for the Treatment of Children and Adolescents With Newly Diagnosed Low Risk Hodgkin Disease
ClinicalTrials.gov ID: NCT00302003
Acronym / sponsor ID: AHOD0431
Conditions: Childhood Favorable Prognosis Hodgkin Lymphoma, Childhood Lymphocyte Depletion Hodgkin Lymphoma, Childhood Mixed Cellularity Hodgkin Lymphoma, Childhood Nodular Sclerosis Hodgkin Lymphoma, Stage I Childhood Hodgkin Lymphoma, Stage II Childhood Hodgkin Lymphoma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 287 participants (actual)
Lead sponsor: Children's Oncology GroupResearch network
Collaborators: National Cancer Institute (NCI)
Study start: Feb 2006
Primary completion: Mar 2012 (actual)
Study completion: 30 Jun 2019 (actual)
First posted: 13 Mar 2006 (estimated)
Results: Posted 9 Feb 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

OBJECTIVES:

Investigate the paradigm of response-based therapy for low-risk Hodgkin's lymphoma by eliminating involved-field radiotherapy (IFRT) in patients who achieve a complete remission (CR) after initial chemotherapy.

IV. Maintain the overall survival for patients with low-risk Hodgkin's lymphoma at or above 97%.

Determine the prognostic significance of very early response as measured by fludeoxyglucose-positron emission tomography (FDG-PET) or gallium after the first course of chemotherapy.

VII. Determine the frequency and severity of late effects of therapy, including thyroid dysfunction, infertility, cardiotoxicity, and second malignant neoplasms.

OUTLINE: This is a multicenter study.

INVOLVED-FIELD RADIOTHERAPY (IFRT): Beginning 4 weeks after completion of chemotherapy, patients undergo IFRT once daily, 5 days a week, for 2.8 weeks. Patients who do not achieve CR go off study.

After completion of study treatment, patients are followed periodically for up to 10 years.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim	Experimental	Radiation: radiation therapy, Drug: doxorubicin hydrochloride, Drug: vincristine sulfate, Drug: prednisone, Drug: cyclophosphamide, Drug: ifosfamide, Drug: vinorelbine tartrate, Drug: dexamethasone, Drug: etoposide phosphate, Drug: cisplatin, Drug: cytarabine, Biological: filgrastimTreatment consists of 3 cycles of Doxorubicin hydrochloride IV (25 mg/m2) days 1 \& 2, Vincristine sulfate IV (1.4 mg/m2 [max 2.8 mg]) Days 1 \& 8, Prednisone orally (40 mg/m2) Days 1-7, Cyclophosphamide IV (600 mg/m2) Days 1 \& 2, Filgrastim by mouth or IV (5 micrograms/kg/dose) 24 hours after Cyclophosphamide complete. See detailed description for remainder of therapy.

Who may qualify

Ages: Up to 21 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (17 listed)

Histologically confirmed Hodgkin's lymphoma meeting the following criteria:
Staging on this study will be determined by the clinical stage; surgical staging is strongly discouraged, except for the rare situation of equivocal imaging studies below the diaphragm
Patients may not have received any previous chemotherapy or radiation therapy; patients may not have received systemic corticosteroids within 30 days of enrollment on this protocol; steroids used for treatment of contrast agent allergy required for computed tomography (CT) scans are acceptable
Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^3
Total bilirubin =< 1.5 x normal

Key exclusion criteria (0 listed)

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 therapyAlso: irradiation, radiotherapy, therapy, radiationUndergo radiation therapy	Radiation	Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
doxorubicin hydrochlorideAlso: ADM, ADR, Adria, Adriamycin PFSGiven IV	Drug	Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
vincristine sulfateAlso: leurocristine sulfate, VCR, Vincasar PFSGiven IV	Drug	Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
prednisoneAlso: DeCortin, DeltraGiven orally	Drug	Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
cyclophosphamideAlso: CPM, CTX, Cytoxan, EndoxanGiven IV	Drug	Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
ifosfamideAlso: Cyfos, Holoxan, IFF, IFXGiven IV	Drug	Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
vinorelbine tartrateAlso: Eunades, navelbine ditartrate, NVB, VNBGiven IV	Drug	Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
dexamethasoneAlso: Aeroseb-Dex, Decaderm, Decadron, DMGiven IV	Drug	Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
etoposide phosphateAlso: ETOP, EtopophosGiven IV	Drug	Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
cisplatinAlso: CACP, CDDP, CPDD, DDPGiven IV	Drug	Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
cytarabineAlso: ARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-UGiven IV	Drug	Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
filgrastimAlso: G-CSF, NeupogenGiven IV or subcutaneously	Biological	Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim

Primary outcome

Event Free Survival Without Receiving Radiation Therapy (EFSnoRT).
Time frame: At 60 months
Survival is defined as the minimum time from study entry to requirement for additional chemotherapy and IFRT for retrieval, occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact. Patients who achieve less than CR after 3 cycles of AV-PC will require IFRT and hence will satisfy this definition at the time of response evaluation. Patients who achieve a CR but who relapse will receive addition chemotherapy and IFRT or intense retrieval and hence will satisfy this definition at the time of the first relapse of Hodgkin disease. This endpoint will be used to compute event free survival without receiving radiation therapy (EFSnoRT).
Intensive Therapy Free Survival (ITFS).
Time frame: At 60 months
Survival is defined as the minimum time from study entry to a relapse of higher risk at any time, any relapse following treatment with protocol mandated IFRT, death from any cause, or the occurrence of a second malignant neoplasm. This will be used to compute intensive therapy free survival (ITFS). Patients without report of such events where censored at last contact. This differs from traditional EFS in that relapse after AVPC* x3 therapy alone that does not place the patient in a higher risk category is not considered a treatment failure. In this definition, higher-risk relapse refers to relapse involving sites and extent of disease that place the patient in the current COG definition of intermediate or high-risk disease. If a patient with CR who experiences a LR relapse is not retreated with protocol-mandated chemotherapy and IFRT, subsequent disease relapses will nevertheless be counted in the analysis of the treatment strategy.
Event Free Survival (EFS)
Time frame: At 60 months
Survival is defined as the minimum time from study entry to a relapse of any kind, death from any cause, or occurrence of a second malignant neoplasm. Patients without report of such events where censored at last contact. This will be used to compute event free survival (EFS).

1 secondary outcome

Overall Survival
Time frame: At 60 months

Results and safety

Results posted to the registry on 9 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim	287	207

Primary outcome: Event Free Survival Without Receiving Radiation Therapy (EFSnoRT).

Time frame: At 60 months. Number (95% Confidence Interval). Unit: Probability of survival

Measure	Group 1 n = 275
Value	0.49 (0.42 to 0.54)

Population analysed: Eligible (n=278) and evaluable response and review of response, n=275. Follow-up for censored patients (n=138) is 76 months (range: 1.8 to 108 months).

Primary outcome: Intensive Therapy Free Survival (ITFS).

Time frame: At 60 months. Number (95% Confidence Interval). Unit: Probability of survival

Measure	Group 1 n = 275
Value	0.89 (0.84 to 0.92)

Population analysed: Eligible (n=278) and evaluable response and review of response, n=275. Follow-up for censored patients (n=245) is 76 months (range: 4.7 to 109 months).

Primary outcome: Event Free Survival (EFS)

Time frame: At 60 months. Number (95% Confidence Interval). Unit: Probability of survival

Measure	Group 1 n = 278
Value	0.79 (0.74 to 0.84)

Population analysed: Eligible (n=278). Follow-up for censored patients (n=223) is 75 months (range: 4.7 to 108 months).

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim	2 of 278 (0.7%)	80 of 278 (28.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37505794Castellino SM, Giulino-Roth L, Harker-Murray P, Kahn JM, Forlenza C, Cho S, Hoppe B, Parsons SK, Kelly KM; COG Hodgkin Lymphoma Committee. Children's Oncology Group's 2023 blueprint for research: Hodgkin lymphoma. Pediatr Blood Cancer. 2023 Sep;70 Suppl 6(Suppl 6):e30580. doi: 10.1002/pbc.30580. Epub 2023 Jul 28.
Derived from this study: PubMed 35763667Parekh A, Keller FG, McCarten KM, Kessel S, Cho S, Pei Q, Wu Y, Castellino SM, Constine LS, Schwartz CL, Hodgson D, Kelly KM, Hoppe BS. Targeted radiotherapy for early-stage, low-risk pediatric Hodgkin lymphoma slow early responders: a COG AHOD0431 analysis. Blood. 2022 Sep 8;140(10):1086-1093. doi: 10.1182/blood.2022016098.
Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data ArchiveLink provided by the sponsor.

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.

Frank Keller, MD principal investigator

Children's Oncology Group

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 0 exclusion criteria. 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 30 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Event Free Survival Without Receiving Radiation Therapy (EFSnoRT). (time frame: At 60 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00302003, which also lists 2 linked publications.

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 30 Mar 2021.