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Positron Emission Tomography for Staging, and Treatment Assessment of Response in Lymphomas (the Pet-star Lymphoma Study)


N/A
18 Years
N/A
Not Enrolling
Both
Hodgkin's Lymphoma, Non Hodgkin's Lymphoma

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Trial Information

Positron Emission Tomography for Staging, and Treatment Assessment of Response in Lymphomas (the Pet-star Lymphoma Study)


It is currently unknown whether modifying treatment based on FDG-PET results is appropriate.
However, clinicians are increasingly using the FDG-PET result, where obtained, in deciding
management. Consequently, it would be premature to mandate PET-based treatment
modifications in this protocol. Patients will be treated with existing protocols at the
discretion of their treating oncologists, based on available information. Oncologists will
be surveyed as to whether FDG-PET scan results could have (or affect patient management, and
the intervention will be recorded).


Group A: Newly Diagnosed

Inclusion Criteria:



- Patients > 18 years of age.

- Confirmed diagnosis of HL or NHL (any histology).

- Any Ann Arbor stage.

- Pre-treatment staging including CT of head and neck, chest, abdomen and pelvis, where
there is a minimum one equivocal finding on the scan, affecting the assignment of
stage or IPI factor (i.e. stage III/IV vs. stage I/II, or a question of extranodal
involvement by disease).

Group B: Response Assessment

Inclusion Criteria:



- Patients > 18 years of age.

- Confirmed diagnosis of HL or NHL (any histology).

- Any Ann Arbor stage.

- Pre-treatment staging including CT neck, chest, abdomen and pelvis. If alternate
assessment of the neck done by clinical palpitation, ultrasound, or MRI is negative,
CT neck is not mandatory.

- Post-treatment staging including CT of head and neck, chest, abdomen and pelvis, at 1
- 6 weeks post-therapy.

- Treated with anthracycline-based chemotherapy, with or without radiation therapy
(based on the stage of the disease). For Stage III/IV patients, PET will be done
following completion of primary chemotherapy. For stage I/II patients, PET will be
done after combined modality therapy, or after chemotherapy alone if this was the
primary intention of therapy.

- Patients with residual mass on CT following primary chemotherapy with either
"unconfirmed" CR (>75% decrease in size) or PR (³50% decrease in size), based on
International workshop criteria.

Exclusion Criteria: Response Assessment

- None Curative treatment Intent

- After initial therapy the response status is: complete response, stable disease, or
progressive disease

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To determine:the frequency in which the FDG-PET scan result will change the clinical management of the patient, and to record the intervention instituted within 3 months of the PET scan 2)early relapse rates for PET positive, and PET negative patients.

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Richard Tsang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Princess Margaret Hospital

Authority:

Canada: Ethics Review Committee

Study ID:

UHN REB 07-0235-C

NCT ID:

NCT00887718

Start Date:

August 2007

Completion Date:

June 2011

Related Keywords:

  • Hodgkin's Lymphoma
  • Non Hodgkin's Lymphoma
  • PET scan and Hodgkin's Lymphoma
  • PET scan and Non Hodgkin's Lymphoma
  • PET scan
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin

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