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NCT00678327 · CITED IN SOURCE DOCUMENTS

Fludeoxyglucose F 18-PET/CT Imaging in Assessing Response to Chemotherapy in Patients With Newly Diagnosed Stage II, Stage III, or Stage IV 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
COMPLETED
Registry last update
2024-05-08

RATIONALE: Imaging procedures, such as fludeoxyglucose F 18 (FDG)-PET/CT scan, done before, during, and after chemotherapy may help doctors assess a patient's response to treatment and help plan the best treatment. It is not yet known whether FDG-PET/CT imaging is effective in assessing response to chemotherapy in patients with newly diagnosed Hodgkin lymphoma. PURPOSE: This randomized phase III trial is studying FDG-PET/CT imaging to see how well it works in assessing response to chemotherapy in patients with newly diagnosed stage II, stage III, or stage IV Hodgkin lymphoma.

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 classical Hodgkin lymphoma (HL) meeting the following criteria: * Meets current WHO classification criteria (i.e., nodular sclerosis, mixed cellularity, lymphocyte rich, and lymphocyte-depleted) * Clinical stage IIB, III, or IV disease OR clinical stage IIA disease with adverse features, including any of the following: * Bulk mediastinal disease, defined as maximal transverse diameter of mass \> 0.33 of the internal thoracic diameter at D5/6 interspace on routine chest x-ray * Disease outside the mediastinum and lymph node or lymph node mass \> 10 cm in diameter * More than two sites of disease * Other poor-risk features that require treatment with full course combination chemotherapy * Newly diagnosed disease * No CNS or meningeal involvement by lymphoma PATIENT CHARACTERISTICS: * ECOG performance status 0-3 * Life expectancy \> 3 months * ANC \> 1,500/mm\^3 (unless there is bone marrow infiltration by lymphoma) * Platelet count \> 100,000/mm\^3 (unless there is bone marrow infiltration by lymphoma) * Creatinine \< 150% of upper limit of normal (ULN) * Bilirubin \< 2.0 times ULN (unless attributed to lymphoma) * Transaminases \< 2.5 times ULN (unless attributed to lymphoma) * LVEF ≥ 50% (in patients with a significant history of ischemic heart disease or hypertension) * Diffusion capacity within 25% of normal predicted value by lung function testing * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Amenable to the administration of a full course of chemotherapy, according to the investigator * Must have access to PET/CT scanning * No poorly controlled diabetes mellitus * No cardiac contraindication to doxorubicin hydrochloride, including abnormal contractility by ECHO or MUGA * No neurological contraindication to chemotherapy (e.g., pre-existing neuropathy) * No other concurrent uncontrolled medical condition * No other active malignant disease within the past 10 years, except fully excised basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the uterine cervix * No known positivity for HIV, hepatitis B surface antigen, or hepatitis C * Routine testing, in the absence of risk factors, is not required * No medical or psychiatric condition that compromises the patient's ability to give informed consent PRIOR CONCURRENT THERAPY: * No prior chemotherapy, radiotherapy or other investigational drug for HL
healthy Volunteers
false
maximum Age
100 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive ABVD chemotherapy comprising doxorubicin hydrochloride IV, bleomycin IV, vinblastine IV, and dacarbazine IV on days 1 and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Biological: bleomycin sulfate
    2. Drug: dacarbazine
    3. Drug: doxorubicin hydrochloride
    4. Drug: vinblastine sulfate
    label
    Arm I
    type
    ACTIVE_COMPARATOR
  2. description
    Patients receive AVD chemotherapy comprising doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV on days 1 and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: dacarbazine
    2. Drug: doxorubicin hydrochloride
    3. Drug: vinblastine sulfate
    label
    Arm II
    type
    ACTIVE_COMPARATOR
  3. description
    Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1; etoposide IV on days 1-3; oral procarbazine hydrochloride and oral prednisolone on days 1-7; and bleomycin IV and vincristine IV on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 8-13 OR pegfilgrastim SC once on day 8. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Biological: bleomycin sulfate
    2. Biological: filgrastim
    3. Biological: pegfilgrastim
    4. Drug: cyclophosphamide
    5. Drug: doxorubicin hydrochloride
    6. Drug: etoposide
    7. Drug: prednisolone
    8. Drug: procarbazine hydrochloride
    9. Drug: vincristine sulfate
    label
    BEACOPP-14 chemotherapy
    type
    EXPERIMENTAL
  4. description
    Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1; etoposide IV on days 1-3; oral procarbazine hydrochloride on days 1-7; oral prednisolone on days 1-14; and bleomycin IV and vincristine IV on day 8. Patients also receive G-CSF SC beginning on day 8 and continuing until blood counts recover OR pegfilgrastim SC once on day 8. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Biological: bleomycin sulfate
    2. Biological: filgrastim
    3. Biological: pegfilgrastim
    4. Drug: cyclophosphamide
    5. Drug: doxorubicin hydrochloride
    6. Drug: etoposide
    7. Drug: prednisolone
    8. Drug: procarbazine hydrochloride
    9. Drug: vincristine sulfate
    label
    BEACOPP-escalated chemotherapy
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm I
    2. BEACOPP-14 chemotherapy
    3. BEACOPP-escalated chemotherapy
    description
    Given IV
    name
    bleomycin sulfate
    type
    BIOLOGICAL
  2. arm Group Labels
    1. BEACOPP-14 chemotherapy
    2. BEACOPP-escalated chemotherapy
    description
    Given subcutaneously
    name
    filgrastim
    type
    BIOLOGICAL
  3. arm Group Labels
    1. BEACOPP-14 chemotherapy
    2. BEACOPP-escalated chemotherapy
    description
    Given subcutaneously
    name
    pegfilgrastim
    type
    BIOLOGICAL
  4. arm Group Labels
    1. BEACOPP-14 chemotherapy
    2. BEACOPP-escalated chemotherapy
    description
    Given IV
    name
    cyclophosphamide
    type
    DRUG
  5. arm Group Labels
    1. Arm I
    2. Arm II
    description
    Given IV
    name
    dacarbazine
    type
    DRUG
  6. arm Group Labels
    1. Arm I
    2. Arm II
    3. BEACOPP-14 chemotherapy
    4. BEACOPP-escalated chemotherapy
    description
    Given IV
    name
    doxorubicin hydrochloride
    type
    DRUG
  7. arm Group Labels
    1. BEACOPP-14 chemotherapy
    2. BEACOPP-escalated chemotherapy
    description
    Given IV
    name
    etoposide
    type
    DRUG
  8. arm Group Labels
    1. BEACOPP-14 chemotherapy
    2. BEACOPP-escalated chemotherapy
    description
    Given orally
    name
    prednisolone
    type
    DRUG
  9. arm Group Labels
    1. BEACOPP-14 chemotherapy
    2. BEACOPP-escalated chemotherapy
    description
    Given orally
    name
    procarbazine hydrochloride
    type
    DRUG
  10. arm Group Labels
    1. Arm I
    2. Arm II
    description
    Given IV
    name
    vinblastine sulfate
    type
    DRUG
  11. arm Group Labels
    1. BEACOPP-14 chemotherapy
    2. BEACOPP-escalated chemotherapy
    description
    Given IV
    name
    vincristine sulfate
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
1202
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    3-year progression-free survival
    time Frame
    3 years
secondary Outcomes
  1. measure
    Overall survival
    time Frame
    5 years after last patient recruited
  2. measure
    Acute and chronic toxicity as assessed by NCI CTCAE v3.0
    time Frame
    5 years after last patient recruited
Full study description
brief Summary
RATIONALE: Imaging procedures, such as fludeoxyglucose F 18 (FDG)-PET/CT scan, done before, during, and after chemotherapy may help doctors assess a patient's response to treatment and help plan the best treatment. It is not yet known whether FDG-PET/CT imaging is effective in assessing response to chemotherapy in patients with newly diagnosed Hodgkin lymphoma. PURPOSE: This randomized phase III trial is studying FDG-PET/CT imaging to see how well it works in assessing response to chemotherapy in patients with newly diagnosed stage II, stage III, or stage IV Hodgkin lymphoma.
detailed Description
OBJECTIVES: * To determine if fludeoxyglucose F 18 (FDG)-PET/CT imaging can be reproducibly and effectively applied in the early assessment of response to chemotherapy in patients with newly diagnosed stage II-IV Hodgkin lymphoma. * To determine if a negative FDG-PET/CT scan after 2 courses of ABVD chemotherapy comprising doxorubicin hydrochloride, bleomycin, vinblastine, and dacarbazine can be used to predict a group of patients for whom it is safe to reduce therapy by the subsequent omission of bleomycin, without detriment to progression-free survival. * To determine if treatment intensification in response to positive FDG-PET/CT imaging after 2 courses of ABVD chemotherapy can improve the outcome by comparison with previous series. OUTLINE: This is a multicenter study. Patients undergo fludeoxyglucose F 18 (FDG)-PET/CT imaging at baseline. Patients then receive ABVD chemotherapy comprising doxorubicin hydrochloride IV, bleomycin IV, vinblastine IV, and dacarbazine IV on days 1 and 15. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Between days 22 and 25 of course 2, patients undergo a second FDG-PET/CT scan to assess response. Subsequent therapy is based on FDG-PET/CT scan results. * Negative FDG-PET/CT scan: Patients with a negative FDG-PET/CT scan are randomized to 1 of 2 treatment arms. * Arm I (ABVD chemotherapy): Patients receive ABVD chemotherapy comprising doxorubicin hydrochloride IV, bleomycin IV, vinblastine IV, and dacarbazine IV on days 1 and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. * Arm II (AVD chemotherapy): Patients receive AVD chemotherapy comprising doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV on days 1 and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. * Positive FDG-PET/CT scan: Patients with a positive FDG-PET/CT scan are assigned to 1 of 2 chemotherapy regimens, as determined by the participating center. * BEACOPP-14 chemotherapy: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1; etoposide IV on days 1-3; oral procarbazine hydrochloride and oral prednisolone on days 1-7; and bleomycin IV and vincristine IV on day 8. Patients also receive filgrastim (G-CSF) subcutaneously (SC) on days 8-13 OR pegfilgrastim SC once on day 8. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. * BEACOPP-escalated chemotherapy: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1; etoposide IV on days 1-3; oral procarbazine hydrochloride on days 1-7; oral prednisolone on days 1-14; and bleomycin IV and vincristine IV on day 8. Patients also receive G-CSF SC beginning on day 8 and continuing until blood counts recover OR pegfilgrastim SC once on day 8. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. After completion of BEACOPP chemotherapy, patients undergo a third FDG-PET/CT scan to assess response. Patients with a negative FDG-PET/CT scan receive 2 more courses of BEACOPP-14 or 1 more course of BEACOPP-escalated chemotherapy. Patients with a persistently positive FDG-PET/CT scan may receive radiotherapy to sites of FDG uptake or salvage chemotherapy, at the investigator's discretion. After completion of study therapy, patients are followed every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually thereafter. Peer Reviewed and Funded or Endorsed by Cancer Research UK.
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
    Luminari S, Fossa A, Trotman J, Molin D, d'Amore F, Enblad G, Berkahn L, Barrington SF, Radford J, Federico M, Kirkwood AA, Johnson PWM. Long-Term Follow-Up of the Response-Adjusted Therapy for Advanced Hodgkin Lymphoma Trial. J Clin Oncol. 2024 Jan 1;42(1):13-18. doi: 10.1200/JCO.23.01177. Epub 2023 Oct 26.
    pmid
    37883739
    type
    DERIVED
  3. citation
    Anderson RA, Remedios R, Kirkwood AA, Patrick P, Stevens L, Clifton-Hadley L, Roberts T, Hatton C, Kalakonda N, Milligan DW, McKay P, Rowntree C, Scott FM, Johnson PWM. Determinants of ovarian function after response-adapted therapy in patients with advanced Hodgkin's lymphoma (RATHL): a secondary analysis of a randomised phase 3 trial. Lancet Oncol. 2018 Oct;19(10):1328-1337. doi: 10.1016/S1470-2045(18)30500-X. Epub 2018 Sep 13.
    pmid
    30220622
    type
    DERIVED
  4. citation
    Johnson P, Federico M, Kirkwood A, Fossa A, Berkahn L, Carella A, d'Amore F, Enblad G, Franceschetto A, Fulham M, Luminari S, O'Doherty M, Patrick P, Roberts T, Sidra G, Stevens L, Smith P, Trotman J, Viney Z, Radford J, Barrington S. Adapted Treatment Guided by Interim PET-CT Scan in Advanced Hodgkin's Lymphoma. N Engl J Med. 2016 Jun 23;374(25):2419-29. doi: 10.1056/NEJMoa1510093.
    pmid
    27332902
    type
    DERIVED
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        pdq-content-list"><ol id="_1136"><li>A randomized prospective trial of 1,214 patients with advanced-stage HL (<a href="/clinicaltrials/NCT00678327">RATHL</a> [NCT00678327]) investigated the use of PET-CT scans after two cycles of ABVD to modify therapy.[<a href="#cit/section_7.25">25</a>,<a href="#cit/section_7.26">26</a>] Patie
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        Updated: February 12, 2025
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        February 12, 2025

    Preserved source evidence · Not medical advice