A Randomised Phase III Trial to Determine the Role of FDG-PET Imaging in Clinical Stages IA/IIA Hodgkin's Disease
16 Years
75 Years
Both
Lymphoma
Trial Information
A Randomised Phase III Trial to Determine the Role of FDG-PET Imaging in Clinical Stages IA/IIA Hodgkin's Disease
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Outcome Time Frame:
up to 5 years after randomisation
Safety Issue:
No
Principal Investigator
John Radford, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Christie Hospital NHS Foundation Trust
Authority:
United Kingdom: NHS Health Research Authority
Study ID:
03_DOG05_07
NCT ID:
NCT00943423
Start Date:
July 2003
Completion Date:
December 2015
Related Keywords:
- Lymphoma
- stage I adult Hodgkin lymphoma
- stage II adult Hodgkin lymphoma
- Hodgkin Disease
- Lymphoma
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