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NCT00943423Active, not recruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 30 Nov 2023

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
602 (actual)
First submitted
20 Jul 2009
Start date
Jul 2003
Primary completion date
Jul 2014
Lead sponsor
University College, London
NCT number
NCT00943423

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 602
  • From Jul 2003 to the primary completion date, Jul 2014
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • 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

Age in the registry: 16 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Christie Hospital
Coordinator of this site? Confirm its status
ManchesterUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.