PET Scan in Planning Treatment in Patients Undergoing Combination Chemotherapy For Stage IA or Stage IIA Hodgkin Lymphoma (RAPID)

University College London (UCL)

Status and phase: Active, not recruiting; Phase 3

Conditions: Lymphoma

Treatments: Other: No further treatment; Radiation: Involved Field Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00943423

03_DOG05_07

EU-20931

ISRCTN99811594

CHNT-RAPID

Details and patient eligibility

About

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.

Full 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.

Enrollment: 602 patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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602 participants in 2 patient groups

Arm I

Active Comparator group

Description:

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

Treatment:

Radiation: Involved Field Radiotherapy

Arm II

Experimental group

Description:

Patients receive no further treatment.

Treatment:

Other: No further treatment