This trial is active, not recruiting.

Condition lymphoma
Treatments involved field radiotherapy, no further treatment
Phase phase 3
Sponsor University College, London
Collaborator Christie Hospital NHS Foundation Trust
Start date July 2003
End date July 2014
Trial size 602 participants
Trial identifier NCT00943423, 03_DOG05_07, CHNT-RAPID, EU-20931, ISRCTN99811594


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Within 6 weeks after completion of course 3 of chemotherapy, patients undergo involved field radiotherapy to disease areas.
involved field radiotherapy
IFRT 30Gy delivered in daily fractions of 1.8 - 2.0Gy
Patients receive no further treatment.
no further treatment

Primary Outcomes

Progression-free survival
time frame: up to 5 years after randomisation

Secondary Outcomes

Incidence of FDG-PET scan positivity/negativity after 3 courses of chemotherapy
time frame: 3 months after treatment start
Survival and cause of death
time frame: up to 5 years after randomisation
Incidence and type of second cancers
time frame: up to 5 years after randomisation

Eligibility Criteria

Male or female participants from 16 years up to 75 years old.

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

Additional Information

Official title A Randomised Phase III Trial to Determine the Role of FDG-PET Imaging in Clinical Stages IA/IIA Hodgkin's Disease
Principal investigator John Radford, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University College, London.