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LymphomaPhase 3RAPIDNCT00943423

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

A Phase 3 study testing Involved Field Radiotherapy and No further treatment in people with Lymphoma, run by University College, London at 1 site in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 16 to 75 years
Conditions the study is for
Lymphoma
What is being tested?
Involved Field Radiotherapy and No further treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
602 participants
Where
1 siteUnited Kingdom
Study dates
Jul 2003to Dec 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 16 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Christie Hospital

    Manchester, England, M20 4BX

Other trials in United Kingdom

About this study

Official title: A Randomised Phase III Trial to Determine the Role of FDG-PET Imaging in Clinical Stages IA/IIA Hodgkin's Disease

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.

Read the 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.
Conditions
Lymphoma
Being tested
Involved Field Radiotherapy, No further treatment
Keywords
stage I adult Hodgkin lymphoma, stage II adult Hodgkin lymphoma
Medical subject headings
Lymphoma, Hodgkin Disease

What participants receive

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

  • Involved Field RadiotherapyRadiation

    IFRT 30Gy delivered in daily fractions of 1.8 - 2.0Gy

  • No further treatmentOther

Study groups in NCT00943423
Study groupRoleWhat they receive
Arm IActive comparatorWithin 6 weeks after completion of course 3 of chemotherapy, patients undergo involved field radiotherapy to disease areas.
Receives: Radiation: Involved Field Radiotherapy
Arm IIExperimentalPatients receive no further treatment.
Receives: Other: No further treatment

What is being measured

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

  1. Progression-free survival

    Measured: up to 5 years after randomisation

Secondary outcomes (3)

  1. Incidence of FDG-PET scan positivity/negativity after 3 courses of chemotherapy

    Measured: 3 months after treatment start

  2. Survival and cause of death

    Measured: up to 5 years after randomisation

  3. Incidence and type of second cancers

    Measured: up to 5 years after randomisation

Timeline

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

  1. First posted22 Jul 2009 (estimated)
  2. Study startJul 2003
  3. Primary completionJul 2014
  4. Study completionDec 2028 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
602 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00943423
Sponsor's protocol ID
03_DOG05_07
Other IDs
CHNT-RAPID, ISRCTN99811594, EU-20931
Acronym
RAPID
Status last verified
Nov 2023
First submitted
20 Jul 2009
Last updated
30 Nov 2023
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 40135712

  • 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.

    PubMed 39774828

  • 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.

    PubMed 36541117

  • 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.

    PubMed 34388007

  • 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.

    PubMed 31935289

  • 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.

    PubMed 31112475

  • 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.

    PubMed 25901426

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Involved Field Radiotherapy and No further treatment in people with Lymphoma, run by University College, London at 1 site in United Kingdom.

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: under way, not looking for participants, as of the sponsor's last update on 30 Nov 2023. 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 Kingdom. 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?

This study is still under way. Results are not available in the source record yet.

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?

Progression-free survival (time frame: up to 5 years after randomisation). 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 NCT00943423, which also lists 7 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 Nov 2023.

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