NCT00943423

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
602

participants targeted

Target at P75+ for phase_3 lymphoma

Timeline
32mo left

Started Jul 2003

Longer than P75 for phase_3 lymphoma

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jul 2003Dec 2028

Study Start

First participant enrolled

July 1, 2003

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2009

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
14.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Expected
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

11 years

First QC Date

July 20, 2009

Last Update Submit

November 29, 2023

Conditions

Lymphoma

Keywords

stage I adult Hodgkin lymphomastage II adult Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

    up to 5 years after randomisation

Secondary Outcomes (3)

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

    3 months after treatment start

  • Survival and cause of death

    up to 5 years after randomisation

  • Incidence and type of second cancers

    up to 5 years after randomisation

Study Arms (2)

Arm I

ACTIVE COMPARATOR

Within 6 weeks after completion of course 3 of chemotherapy, patients undergo involved field radiotherapy to disease areas.

Radiation: Involved Field Radiotherapy

Arm II

EXPERIMENTAL

Patients receive no further treatment.

Other: No further treatment

Interventions

Involved Field RadiotherapyRADIATION

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

Arm I
No further treatmentOTHER
Arm II

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

Related Publications (7)

  • 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: 40135712DERIVED

  • 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: 39774828DERIVED

  • 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: 36541117DERIVED

  • 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: 34388007DERIVED

  • 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: 31935289DERIVED

  • 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: 31112475DERIVED

  • 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: 25901426DERIVED

Related Links

MeSH Terms

Conditions

LymphomaHodgkin Disease

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • John Radford, MD

    The Christie NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2009

First Posted

July 22, 2009

Study Start

July 1, 2003

Primary Completion

July 1, 2014

Study Completion (Estimated)

December 1, 2028

Last Updated

November 30, 2023

Record last verified: 2023-11

Locations

GB(1)