Hodgkin LymphomaHL01NCT00850200

Proton Therapy for Hodgkin Lymphoma

A study testing Proton Radiation Plan, Conventional Photon Radiation Plan and Intensity Modulated Radiation Plan in people with Hodgkin Lymphoma, run by University of Florida 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

Search all trials

Trial summary

The purpose of this study is to reduce the risk of radiation related side effects and complications by treating with radiation (protons or photons) that exposes less of normal organs to low dose radiation. Read more about this study

Who is it for?: Ages 6 years and older
Conditions the study is for: Hodgkin Lymphoma
What is being tested?: Proton Radiation Plan, Conventional Photon Radiation Plan and Intensity Modulated Radiation Plan
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: Aug 2009to 9 Jan 2018
Phase: Interventional
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 6 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Confirmed "classic" Hodgkin lymphoma.
Completed chemotherapy.

Who cannot join

Prior radiotherapy.
Prior or concurrent cancer other than non-melanomatous skin cancer.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Florida Proton Therapy Institute
Jacksonville, Florida, 32206

Other trials in United States

About this study

Official title: Improving the Therapeutic Ratio by Using Proton Beam Radiation Therapy for Patients With Stage IA-IIIBX (Bulky/Non-bulky) Hodgkin Lymphoma Involving the Mediastinum Following Standard Chemotherapy

Read the detailed description

3 treatment plans will be created to deliver between a total of 21-39.6 Gray (Gy)/Centigray Equivalents (CGE) to the planning target volume (PTV).

Proton Plan
Conventional Plan
Intensity Modulated Radiotherapy (IMRT) Plan

The patient will then receive the radiation modality with the lowest percentage of the body receiving 4 Gy (V4Gy/CGE)

Conditions: Hodgkin Lymphoma
Being tested: Proton Radiation Plan, Conventional Photon Radiation Plan, Intensity Modulated Radiation Plan
Keywords: Hodgkin Lymphoma, Proton Radiation
Medical subject headings: Hodgkin Disease

What participants receive

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

Proton Radiation PlanRadiation
Between 21-39.6 Gy/CGE to the PTV
Conventional Photon Radiation PlanRadiation
Between 21-39.6 Gy/CGE to the PTV
Intensity Modulated Radiation PlanRadiation
Between 21-39.6 Gy/CGE to the PTV

Study groups in NCT00850200
Study group	Role	What they receive
Proton Radiation Plan	Experimental	Not described Receives: Radiation: Proton Radiation Plan
Conventional Photon Radiation Plan	Active comparator	Not described Receives: Radiation: Conventional Photon Radiation Plan
Intensity Modulated Radiation Plan	Active comparator	Not described Receives: Radiation: Intensity Modulated Radiation Plan

What is being measured

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

Comparison of Normal Tissue Exposed to Greater Than or Equal to 4 Gy/CGE With Use of Proton Therapy Compared to Both Intensity Modulated Radiotherapy (IMRT) and Conventional Therapy.
Measured: Immediately proceeding completion of each of the three treatment plans

Secondary outcomes (2)

Percentage of Participants Who Survived
Overall survival as assessed with the Kaplan-Meier product limit method.
Measured: 4 years after beginning of radiation therapy
Percentage of Participants Who Did Not Have Disease Progression
Disease free survival as assessed with the Kaplan-Meier product limit method
Measured: 4 years after beginning of radiation therapy

Timeline

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

Aug 20099 Jan 2018

First posted24 Feb 2009 (estimated)
Study startAug 2009
Primary completionMay 2013
Study completion9 Jan 2018

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 (24)Papers the sponsor has linked to this study.
Other trials for Hodgkin LymphomaStudies of the same condition, open and under way.
More trials run by University of FloridaThe 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 N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00850200
Sponsor's protocol ID: UFPTI 0806 - HL01
Acronym: HL01
Status last verified: Jan 2019
First submitted: 20 Feb 2009
Last updated: 31 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Bonadonna G, Bonfante V, Viviani S, Di Russo A, Villani F, Valagussa P. ABVD plus subtotal nodal versus involved-field radiotherapy in early-stage Hodgkin's disease: long-term results. J Clin Oncol. 2004 Jul 15;22(14):2835-41. doi: 10.1200/JCO.2004.12.170. Epub 2004 Jun 15.
PubMed 15199092
Horning SJ, Hoppe RT, Breslin S, Bartlett NL, Brown BW, Rosenberg SA. Stanford V and radiotherapy for locally extensive and advanced Hodgkin's disease: mature results of a prospective clinical trial. J Clin Oncol. 2002 Feb 1;20(3):630-7. doi: 10.1200/JCO.2002.20.3.630.
PubMed 11821442
Straus DJ, Portlock CS, Qin J, Myers J, Zelenetz AD, Moskowitz C, Noy A, Goy A, Yahalom J. Results of a prospective randomized clinical trial of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) followed by radiation therapy (RT) versus ABVD alone for stages I, II, and IIIA nonbulky Hodgkin disease. Blood. 2004 Dec 1;104(12):3483-9. doi: 10.1182/blood-2004-04-1311. Epub 2004 Aug 17.
PubMed 15315964
Oeffinger KC, Mertens AC, Sklar CA, Kawashima T, Hudson MM, Meadows AT, Friedman DL, Marina N, Hobbie W, Kadan-Lottick NS, Schwartz CL, Leisenring W, Robison LL; Childhood Cancer Survivor Study. Chronic health conditions in adult survivors of childhood cancer. N Engl J Med. 2006 Oct 12;355(15):1572-82. doi: 10.1056/NEJMsa060185.
PubMed 17035650
Constine LS, Tarbell N, Hudson MM, Schwartz C, Fisher SG, Muhs AG, Basu SK, Kun LE, Ng A, Mauch P, Sandhu A, Culakova E, Lyman G, Mendenhall N. Subsequent malignancies in children treated for Hodgkin's disease: associations with gender and radiation dose. Int J Radiat Oncol Biol Phys. 2008 Sep 1;72(1):24-33. doi: 10.1016/j.ijrobp.2008.04.067.
PubMed 18722263
van Leeuwen FE, Klokman WJ, Stovall M, Dahler EC, van't Veer MB, Noordijk EM, Crommelin MA, Aleman BM, Broeks A, Gospodarowicz M, Travis LB, Russell NS. Roles of radiation dose, chemotherapy, and hormonal factors in breast cancer following Hodgkin's disease. J Natl Cancer Inst. 2003 Jul 2;95(13):971-80. doi: 10.1093/jnci/95.13.971.
PubMed 12837833
Ng AK, Bernardo MV, Weller E, Backstrand K, Silver B, Marcus KC, Tarbell NJ, Stevenson MA, Friedberg JW, Mauch PM. Second malignancy after Hodgkin disease treated with radiation therapy with or without chemotherapy: long-term risks and risk factors. Blood. 2002 Sep 15;100(6):1989-96. doi: 10.1182/blood-2002-02-0634.
PubMed 12200357
Behringer K, Josting A, Schiller P, Eich HT, Bredenfeld H, Diehl V, Engert A; German Hodgkin Lymphoma Study Group. Solid tumors in patients treated for Hodgkin's disease: a report from the German Hodgkin Lymphoma Study Group. Ann Oncol. 2004 Jul;15(7):1079-85. doi: 10.1093/annonc/mdh273.
PubMed 15205202
Campbell BA, Voss N, Pickles T, Morris J, Gascoyne RD, Savage KJ, Connors JM. Involved-nodal radiation therapy as a component of combination therapy for limited-stage Hodgkin's lymphoma: a question of field size. J Clin Oncol. 2008 Nov 10;26(32):5170-4. doi: 10.1200/JCO.2007.15.1001. Epub 2008 Oct 6.
PubMed 18838714
Girinsky T, Pichenot C, Beaudre A, Ghalibafian M, Lefkopoulos D. Is intensity-modulated radiotherapy better than conventional radiation treatment and three-dimensional conformal radiotherapy for mediastinal masses in patients with Hodgkin's disease, and is there a role for beam orientation optimization and dose constraints assigned to virtual volumes? Int J Radiat Oncol Biol Phys. 2006 Jan 1;64(1):218-26. doi: 10.1016/j.ijrobp.2005.06.004. Epub 2005 Sep 19.
PubMed 16169675
Goodman KA, Toner S, Hunt M, Wu EJ, Yahalom J. Intensity-modulated radiotherapy for lymphoma involving the mediastinum. Int J Radiat Oncol Biol Phys. 2005 May 1;62(1):198-206. doi: 10.1016/j.ijrobp.2004.08.048.
PubMed 15850922
Nieder C, Schill S, Kneschaurek P, Molls M. Influence of different treatment techniques on radiation dose to the LAD coronary artery. Radiat Oncol. 2007 Jun 5;2:20. doi: 10.1186/1748-717X-2-20.
PubMed 17547777
Schneider U, Lomax A, Lombriser N. Comparative risk assessment of secondary cancer incidence after treatment of Hodgkin's disease with photon and proton radiation. Radiat Res. 2000 Oct;154(4):382-8. doi: 10.1667/0033-7587(2000)154[0382:craosc]2.0.co;2.
PubMed 11023601
Sigurdson AJ, Ronckers CM, Mertens AC, Stovall M, Smith SA, Liu Y, Berkow RL, Hammond S, Neglia JP, Meadows AT, Sklar CA, Robison LL, Inskip PD. Primary thyroid cancer after a first tumour in childhood (the Childhood Cancer Survivor Study): a nested case-control study. Lancet. 2005 Jun 11-17;365(9476):2014-23. doi: 10.1016/S0140-6736(05)66695-0.
PubMed 15950715
Nieder C, Schill S, Kneschaurek P, Molls M. Comparison of three different mediastinal radiotherapy techniques in female patients: Impact on heart sparing and dose to the breasts. Radiother Oncol. 2007 Mar;82(3):301-7. doi: 10.1016/j.radonc.2006.10.015. Epub 2006 Dec 6.
PubMed 17156873

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Hodgkin Lymphoma trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving the Therapeutic Ratio by Using Proton Beam Radiation Therapy for Patients With Stage IA-IIIBX (Bulky/Non-bulky) Hodgkin Lymphoma Involving the Mediastinum Following Standard Chemotherapy
ClinicalTrials.gov ID: NCT00850200
Acronym / sponsor ID: HL01 / UFPTI 0806 - HL01
Conditions: Hodgkin Lymphoma
Keywords: Hodgkin Lymphoma, Proton Radiation
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Study start: Aug 2009
Primary completion: May 2013 (actual)
Study completion: 9 Jan 2018 (actual)
First posted: 24 Feb 2009 (estimated)
Results: Posted 21 Mar 2014

Clinical summary

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

Detailed description

3 treatment plans will be created to deliver between a total of 21-39.6 Gray (Gy)/Centigray Equivalents (CGE) to the planning target volume (PTV).

Proton Plan
Conventional Plan
Intensity Modulated Radiotherapy (IMRT) Plan

The patient will then receive the radiation modality with the lowest percentage of the body receiving 4 Gy (V4Gy/CGE)

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Proton Radiation Plan	Experimental	Radiation: Proton Radiation Plan
Conventional Photon Radiation Plan	Active comparator	Radiation: Conventional Photon Radiation Plan
Intensity Modulated Radiation Plan	Active comparator	Radiation: Intensity Modulated Radiation Plan

Who may qualify

Ages: 6 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Confirmed "classic" Hodgkin lymphoma.
Completed chemotherapy.

Key exclusion criteria (2 listed)

Prior radiotherapy.
Prior or concurrent cancer other than non-melanomatous skin cancer.

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
Proton Radiation PlanBetween 21-39.6 Gy/CGE to the PTV	Radiation	Proton Radiation Plan
Conventional Photon Radiation PlanBetween 21-39.6 Gy/CGE to the PTV	Radiation	Conventional Photon Radiation Plan
Intensity Modulated Radiation PlanBetween 21-39.6 Gy/CGE to the PTV	Radiation	Intensity Modulated Radiation Plan

Primary outcome

Comparison of Normal Tissue Exposed to Greater Than or Equal to 4 Gy/CGE With Use of Proton Therapy Compared to Both Intensity Modulated Radiotherapy (IMRT) and Conventional Therapy.
Time frame: Immediately proceeding completion of each of the three treatment plans

2 secondary outcomes

Percentage of Participants Who Survived
Time frame: 4 years after beginning of radiation therapy
Percentage of Participants Who Did Not Have Disease Progression
Time frame: 4 years after beginning of radiation therapy

Results and safety

Results posted to the registry on 21 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Optimal Treatment Plan	20	15

Primary outcome: Comparison of Normal Tissue Exposed to Greater Than or Equal to 4 Gy/CGE With Use of Proton Therapy Compared to Both Intensity Modulated Radiotherapy (IMRT) and Conventional Therapy.

Time frame: Immediately proceeding completion of each of the three treatment plans. Median (Full Range). Unit: percentage of body receiving 4 Gy

Measure	Proton Radiation Plan n = 19	Conventional Photon Radiation Plan n = 19	Intensity Modulated Radiation Plan n = 19
Value	0.161 (0.062 to 0.346)	0.291 (0.162 to 0.497)	0.355 (0.189 to 0.811)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Cumulative adverse events were collected via regular 6 month patient follow-ups after the completion of treatment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Superior Treatment Plan	0 of 15 (0%)	6 of 15 (40%)	1 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15199092Bonadonna G, Bonfante V, Viviani S, Di Russo A, Villani F, Valagussa P. ABVD plus subtotal nodal versus involved-field radiotherapy in early-stage Hodgkin's disease: long-term results. J Clin Oncol. 2004 Jul 15;22(14):2835-41. doi: 10.1200/JCO.2004.12.170. Epub 2004 Jun 15.
Background: PubMed 11821442Horning SJ, Hoppe RT, Breslin S, Bartlett NL, Brown BW, Rosenberg SA. Stanford V and radiotherapy for locally extensive and advanced Hodgkin's disease: mature results of a prospective clinical trial. J Clin Oncol. 2002 Feb 1;20(3):630-7. doi: 10.1200/JCO.2002.20.3.630.
Background: PubMed 15315964Straus DJ, Portlock CS, Qin J, Myers J, Zelenetz AD, Moskowitz C, Noy A, Goy A, Yahalom J. Results of a prospective randomized clinical trial of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) followed by radiation therapy (RT) versus ABVD alone for stages I, II, and IIIA nonbulky Hodgkin disease. Blood. 2004 Dec 1;104(12):3483-9. doi: 10.1182/blood-2004-04-1311. Epub 2004 Aug 17.
Background: PubMed 17035650Oeffinger KC, Mertens AC, Sklar CA, Kawashima T, Hudson MM, Meadows AT, Friedman DL, Marina N, Hobbie W, Kadan-Lottick NS, Schwartz CL, Leisenring W, Robison LL; Childhood Cancer Survivor Study. Chronic health conditions in adult survivors of childhood cancer. N Engl J Med. 2006 Oct 12;355(15):1572-82. doi: 10.1056/NEJMsa060185.
Background: PubMed 18722263Constine LS, Tarbell N, Hudson MM, Schwartz C, Fisher SG, Muhs AG, Basu SK, Kun LE, Ng A, Mauch P, Sandhu A, Culakova E, Lyman G, Mendenhall N. Subsequent malignancies in children treated for Hodgkin's disease: associations with gender and radiation dose. Int J Radiat Oncol Biol Phys. 2008 Sep 1;72(1):24-33. doi: 10.1016/j.ijrobp.2008.04.067.
Background: PubMed 12837833van Leeuwen FE, Klokman WJ, Stovall M, Dahler EC, van't Veer MB, Noordijk EM, Crommelin MA, Aleman BM, Broeks A, Gospodarowicz M, Travis LB, Russell NS. Roles of radiation dose, chemotherapy, and hormonal factors in breast cancer following Hodgkin's disease. J Natl Cancer Inst. 2003 Jul 2;95(13):971-80. doi: 10.1093/jnci/95.13.971.
Background: PubMed 12200357Ng AK, Bernardo MV, Weller E, Backstrand K, Silver B, Marcus KC, Tarbell NJ, Stevenson MA, Friedberg JW, Mauch PM. Second malignancy after Hodgkin disease treated with radiation therapy with or without chemotherapy: long-term risks and risk factors. Blood. 2002 Sep 15;100(6):1989-96. doi: 10.1182/blood-2002-02-0634.
Background: PubMed 15205202Behringer K, Josting A, Schiller P, Eich HT, Bredenfeld H, Diehl V, Engert A; German Hodgkin Lymphoma Study Group. Solid tumors in patients treated for Hodgkin's disease: a report from the German Hodgkin Lymphoma Study Group. Ann Oncol. 2004 Jul;15(7):1079-85. doi: 10.1093/annonc/mdh273.
Background: PubMed 18838714Campbell BA, Voss N, Pickles T, Morris J, Gascoyne RD, Savage KJ, Connors JM. Involved-nodal radiation therapy as a component of combination therapy for limited-stage Hodgkin's lymphoma: a question of field size. J Clin Oncol. 2008 Nov 10;26(32):5170-4. doi: 10.1200/JCO.2007.15.1001. Epub 2008 Oct 6.
Background: PubMed 16169675Girinsky T, Pichenot C, Beaudre A, Ghalibafian M, Lefkopoulos D. Is intensity-modulated radiotherapy better than conventional radiation treatment and three-dimensional conformal radiotherapy for mediastinal masses in patients with Hodgkin's disease, and is there a role for beam orientation optimization and dose constraints assigned to virtual volumes? Int J Radiat Oncol Biol Phys. 2006 Jan 1;64(1):218-26. doi: 10.1016/j.ijrobp.2005.06.004. Epub 2005 Sep 19.
Background: PubMed 15850922Goodman KA, Toner S, Hunt M, Wu EJ, Yahalom J. Intensity-modulated radiotherapy for lymphoma involving the mediastinum. Int J Radiat Oncol Biol Phys. 2005 May 1;62(1):198-206. doi: 10.1016/j.ijrobp.2004.08.048.
Background: PubMed 17547777Nieder C, Schill S, Kneschaurek P, Molls M. Influence of different treatment techniques on radiation dose to the LAD coronary artery. Radiat Oncol. 2007 Jun 5;2:20. doi: 10.1186/1748-717X-2-20.

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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.

Bradford S Hoppe, MD, MPH principal investigator

University of Florida

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 2 inclusion and 2 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 31 Jan 2019. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Mar 2014). 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?

Comparison of Normal Tissue Exposed to Greater Than or Equal to 4 Gy/CGE With Use of Proton Therapy Compared to Both Intensity Modulated Radiotherapy (IMRT) and Conventional Therapy. (time frame: Immediately proceeding completion of each of the three treatment plans). 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 NCT00850200, which also lists 24 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 31 Jan 2019.