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

Lymphoma Clinical Trial

— RAPID  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00943423
• Other study ID #: 03_DOG05_07
• Secondary ID: CHNT-RAPIDISRCTN
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 2003
• Est. completion date: December 2028

Study information

• Verified date: November 2023
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 602
• Est. completion date: December 2028
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma

Intervention

Radiation:
• Involved Field Radiotherapy
IFRT 30Gy delivered in daily fractions of 1.8 - 2.0Gy

Other:
• No further treatment

Locations

Country	Name	City	State
United Kingdom	Christie Hospital	Manchester	England

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	The Christie NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		up to 5 years after randomisation
Secondary	Incidence of FDG-PET scan positivity/negativity after 3 courses of chemotherapy		3 months after treatment start
Secondary	Survival and cause of death		up to 5 years after randomisation
Secondary	Incidence and type of second cancers		up to 5 years after randomisation

External Links

•   Clinical trial summary from the UCL CTC website