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NCT00943423 · CITED IN SOURCE DOCUMENTS

PET Scan in Planning Treatment in Patients Undergoing Combination Chemotherapy For Stage IA or Stage IIA Hodgkin Lymphoma

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2023-11-30

RATIONALE: A PET scan may help doctors learn how the cancer responded to combination chemotherapy and whether radiation therapy is also required. PURPOSE: This randomized phase III trial is studying giving a PET scan to see how well it works in deciding whether patients who have received combination chemotherapy for stage IA or stage IIA Hodgkin lymphoma also need radiation therapy.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Histologically confirmed Hodgkin Lymphoma * Stage IA or IIA disease * No stage IA Hodgkin lymphoma with no clinical or CT evidence of disease after diagnostic biopsy * Above the diaphragm with no mediastinal bulk, defined as maximum transverse diameter of mediastinal mass * Internal thoracic diameter at level of D5/6 interspace \> 0.33 * Bulky disease at other sites, defined as nodal mass with transverse diameter ≥ 10 cm allowed PATIENT CHARACTERISTICS: * Not pregnant or nursing * Fertile patients must use effective contraception during and for ≥ 6 months * No prior malignancy except appropriately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix * No severe underlying illness considered to make the trial therapy hazardous (i.e., severe heart disease or lung fibrosis) * Willing to travel to the nearest PET scan center * Able to comply with protocol follow-up arrangements PRIOR CONCURRENT THERAPY: * No prior treatment for Hodgkin lymphoma * No contraindications to chemotherapy or radiotherapy
healthy Volunteers
false
maximum Age
75 Years
minimum Age
16 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Within 6 weeks after completion of course 3 of chemotherapy, patients undergo involved field radiotherapy to disease areas.
    intervention Names
    1. Radiation: Involved Field Radiotherapy
    label
    Arm I
    type
    ACTIVE_COMPARATOR
  2. description
    Patients receive no further treatment.
    intervention Names
    1. Other: No further treatment
    label
    Arm II
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm I
    description
    IFRT 30Gy delivered in daily fractions of 1.8 - 2.0Gy
    name
    Involved Field Radiotherapy
    type
    RADIATION
  2. arm Group Labels
    1. Arm II
    name
    No further treatment
    type
    OTHER
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
602
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Progression-free survival
    time Frame
    up to 5 years after randomisation
secondary Outcomes
  1. measure
    Incidence of FDG-PET scan positivity/negativity after 3 courses of chemotherapy
    time Frame
    3 months after treatment start
  2. measure
    Survival and cause of death
    time Frame
    up to 5 years after randomisation
  3. measure
    Incidence and type of second cancers
    time Frame
    up to 5 years after randomisation
Full study description
brief Summary
RATIONALE: A PET scan may help doctors learn how the cancer responded to combination chemotherapy and whether radiation therapy is also required. PURPOSE: This randomized phase III trial is studying giving a PET scan to see how well it works in deciding whether patients who have received combination chemotherapy for stage IA or stage IIA Hodgkin lymphoma also need radiation therapy.
detailed Description
OBJECTIVES: * Determine whether patients with stage IA or IIA Hodgkin lymphoma who have a negative fludeoxyglucose F 18 positron emission tomography (FDG-PET) imaging after 3 courses of chemotherapy comprising doxorubicin hydrochloride, bleomycin sulfate, vinblastine, and dacarbazine (ABVD) require consolidation radiotherapy (to areas of previous involvement) in order to delay or prevent disease progression. OUTLINE: Patients receive doxorubicin hydrochloride IV, bleomycin sulfate IV, vinblastine IV, and dacarbazine IV (ABVD) on days 1 and 15. Treatment repeats every 28 days for 3 courses. On day 15 of the third course of chemotherapy, patients undergo a CT scan of the neck, thorax, abdomen and pelvis. Patients with nonresponsive disease or progressive disease are removed from the study. Patients who achieve response undergo fludeoxyglucose F 18 positron emission tomography (FDG-PET). Patients with a positive FDG-PET scan receive an additional course of ABVD and undergo involved field radiotherapy. Patients with a negative FDG-PET scan are randomized to 1 of 2 treatment arms. * Arm I: Within 6 weeks after completion of course 3 of chemotherapy, patients undergo involved field radiotherapy to disease areas. * Arm II: Patients receive no further treatment. After completion of study therapy, patients are followed up every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
Source references
references
  1. citation
    Kreuzberger N, Goldkuhle M, von Tresckow B, Kobe C, Sickinger MT, Monsef I, Skoetz N. Positron emission tomography-adapted therapy for first-line treatment in adults with Hodgkin lymphoma. Cochrane Database Syst Rev. 2025 Mar 26;3(3):CD010533. doi: 10.1002/14651858.CD010533.pub3.
    pmid
    40135712
    type
    DERIVED
  2. citation
    Phillips EH, Counsell N, Illidge T, Andre M, Aurer I, Fiaccadori V, Fortpied C, Neven A, Federico M, Barrington SF, Raemaekers J, Radford J. Maximum tumor diameter is associated with relapse risk in limited-stage Hodgkin lymphoma: an international study. Blood Adv. 2025 May 13;9(9):2266-2274. doi: 10.1182/bloodadvances.2024015140.
    pmid
    39774828
    type
    DERIVED
  3. citation
    Fiaccadori V, Neven A, Fortpied C, Aurer I, Andre M, Federico M, Counsell N, Phillips EH, Clifton-Hadley L, Barrington SF, Illidge T, Radford J, Raemaekers JMM. Relapse patterns in early-PET negative, limited-stage Hodgkin lymphoma (HL) after ABVD with or without radiotherapy-a joint analysis of EORTC/LYSA/FIL H10 and NCRI RAPID trials. Br J Haematol. 2023 Mar;200(6):731-739. doi: 10.1111/bjh.18594. Epub 2022 Dec 21.
    pmid
    36541117
    type
    DERIVED
  4. citation
    Cutter DJ, Ramroth J, Diez P, Buckle A, Ntentas G, Popova B, Clifton-Hadley L, Hoskin PJ, Darby SC, Radford J, Illidge T. Predicted Risks of Cardiovascular Disease Following Chemotherapy and Radiotherapy in the UK NCRI RAPID Trial of Positron Emission Tomography-Directed Therapy for Early-Stage Hodgkin Lymphoma. J Clin Oncol. 2021 Nov 10;39(32):3591-3601. doi: 10.1200/JCO.21.00408. Epub 2021 Aug 13.
    pmid
    34388007
    type
    DERIVED
  5. citation
    Illidge TM, Phillips EH, Counsell N, Pettengell R, Johnson PWM, Culligan DJ, Popova B, Clifton-Hadley L, McMillan A, Hoskin P, Barrington SF, Radford J. Maximum tumor diameter is associated with event-free survival in PET-negative patients with stage I/IIA Hodgkin lymphoma. Blood Adv. 2020 Jan 14;4(1):203-206. doi: 10.1182/bloodadvances.2019001023.
    pmid
    31935289
    type
    DERIVED
  6. citation
    Barrington SF, Phillips EH, Counsell N, Hancock B, Pettengell R, Johnson P, Townsend W, Culligan D, Popova B, Clifton-Hadley L, McMillan A, Hoskin P, O'Doherty MJ, Illidge T, Radford J. Positron Emission Tomography Score Has Greater Prognostic Significance Than Pretreatment Risk Stratification in Early-Stage Hodgkin Lymphoma in the UK RAPID Study. J Clin Oncol. 2019 Jul 10;37(20):1732-1741. doi: 10.1200/JCO.18.01799. Epub 2019 May 21.
    pmid
    31112475
    type
    DERIVED
  7. citation
    Radford J, Illidge T, Counsell N, Hancock B, Pettengell R, Johnson P, Wimperis J, Culligan D, Popova B, Smith P, McMillan A, Brownell A, Kruger A, Lister A, Hoskin P, O'Doherty M, Barrington S. Results of a trial of PET-directed therapy for early-stage Hodgkin's lymphoma. N Engl J Med. 2015 Apr 23;372(17):1598-607. doi: 10.1056/NEJMoa1408648.
    pmid
    25901426
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        ">EORTC/LYSA/FIL H10</a> [NCT00433433][<a href="#cit/section_5.14">14</a>,<a href="#cit/section_5.15">15</a>]; <a href="/clinicaltrials/NCT00943423">RAPID</a> [NCT00943423][<a href="#cit/section_5.16">16</a>,<a href="#cit/section_5.17">17</a>]; and <a href="/clinicaltrials/NCT00736320">GHSG HD16</a> [NCT00736320][<a href="#cit/se
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        e to give four or more cycles of ABVD when omitting radiation therapy.</p></li><li>ABVD was given for three cycles (six doses) in the <a href="/clinicaltrials/NCT00943423">RAPID</a> study,[<a href="#cit/section_5.16">16</a>] for four cycles (eight doses) in the <a href="/clinicaltrials/NCT00433433">EORTC/LYSA/FIL H10</a> study,[
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        14">14</a>] and the other study (GHSG HD16) added IFRT to 30 Gy.[<a href="#cit/section_5.18">18</a>]<p id="_1252" tabindex="-1">In the <a href="/clinicaltrials/NCT00943423">RAPID</a> study (NCT00943423), patients with postchemotherapy PET-CT Deauville scores of 5 (uptake &#8805;3 times maximum liver uptake) had inferior 5-year PF
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        y (GHSG HD16) added IFRT to 30 Gy.[<a href="#cit/section_5.18">18</a>]<p id="_1252" tabindex="-1">In the <a href="/clinicaltrials/NCT00943423">RAPID</a> study (NCT00943423), patients with postchemotherapy PET-CT Deauville scores of 5 (uptake &#8805;3 times maximum liver uptake) had inferior 5-year PFS rates (61.9%; 95% CI, 41.1%&
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      source title
      Hodgkin Lymphoma Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: February 12, 2025
        datetime
        2025-02-12T12:00:00Z
        display
        February 12, 2025

    Preserved source evidence · Not medical advice