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

Phase 3
16 Years
75 Years
Open (Enrolling)

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Trial Information

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


- 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


- 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


- 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


- No prior treatment for Hodgkin lymphoma

- No contraindications to chemotherapy or radiotherapy

Type of Study:


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:


Principal Investigator

John Radford, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Christie Hospital NHS Foundation Trust


United Kingdom: NHS Health Research Authority

Study ID:




Start Date:

July 2003

Completion Date:

December 2015

Related Keywords:

  • Lymphoma
  • stage I adult Hodgkin lymphoma
  • stage II adult Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma