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History of Changes for Study: NCT00943423
PET Scan in Planning Treatment in Patients Undergoing Combination Chemotherapy For Stage IA or Stage IIA Hodgkin Lymphoma
Latest version (submitted November 29, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 July 21, 2009 None (earliest Version on record)
2 July 23, 2009 Study Description and Study Status
3 December 11, 2009 Arms and Interventions and Study Status
4 May 9, 2013 Recruitment Status, Study Status, Study Identification, Arms and Interventions, Study Design, Sponsor/Collaborators, Contacts/Locations, Outcome Measures and Oversight
5 December 3, 2014 Study Status
6 May 17, 2016 Study Status
7 May 1, 2018 Study Status and References
8 October 22, 2019 Study Status
9 November 29, 2023 Study Status
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Study NCT00943423
Submitted Date:  July 21, 2009 (v1)
Open or close this module Study Identification
Unique Protocol ID: CDR0000641094
Brief Title: PET Scan in Planning Treatment in Patients Undergoing Combination Chemotherapy For Stage IA or Stage IIA Hodgkin Lymphoma
Official Title: A Randomised Phase III Trial to Determine the Role of FDG-PET Imaging in Clinical Stages IA/IIA Hodgkin's Disease
Secondary IDs: CHNT-RAPID
ISRCTN99811594
EU-20931
Open or close this module Study Status
Record Verification: July 2009
Overall Status: Recruiting
Study Start: July 2003
Primary Completion: December 2009 [Anticipated]
Study Completion:
First Submitted: July 20, 2009
First Submitted that
Met QC Criteria:		 July 21, 2009
First Posted: July 22, 2009 [Estimate]
Last Update Submitted that
Met QC Criteria:		 July 21, 2009
Last Update Posted: July 22, 2009 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: The Christie NHS Foundation Trust
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module 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 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 every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.
Open or close this module Conditions
Conditions: Lymphoma
Keywords: stage I adult Hodgkin lymphoma
stage II adult Hodgkin lymphoma
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model:
Number of Arms: 2
Masking: (masked roles unspecified)
Allocation: Randomized
Enrollment: 400 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Arm I
Within 6 weeks after completion of course 3 of chemotherapy, patients undergo involved field radiotherapy to disease areas.
 Radiation: radiation therapy
Patients undergo involved field radiotherapy
No Intervention: Arm II
Patients receive no further treatment.
 Procedure: observation
Patients do not receive further treatment
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Progression-free survival
Secondary Outcome Measures:
1. Incidence of FDG-PET scan positivity/negativity after 3 courses of chemotherapy
2. Survival and cause of death
3. Incidence and type of second cancers
Open or close this module Eligibility
Minimum Age: 16 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Study Officials: John Radford, MD
Principal Investigator
The Christie NHS Foundation Trust
Locations: United Kingdom, England
Christie Hospital
[Recruiting]
Manchester, England, United Kingdom, M20 4BX
Contact:Contact: John Radford, MD 44-161-446-3753
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
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