Status:
ACTIVE_NOT_RECRUITING
PET Scan in Planning Treatment in Patients Undergoing Combination Chemotherapy For Stage IA or Stage IIA Hodgkin Lymphoma
Lead Sponsor:
University College, London
Collaborating Sponsors:
The Christie NHS Foundation Trust
Conditions:
Lymphoma
Eligibility:
All Genders
16-75 years
Phase:
PHASE3
Brief 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 ...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2028
Estimated Enrollment :
602 Patients enrolled
Trial Details
Trial ID
NCT00943423
Start Date
July 1 2003
End Date
December 1 2028
Last Update
November 30 2023
Active Locations (1)
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1
Christie Hospital
Manchester, England, United Kingdom, M20 4BX