The aim of the trial is to individualize treatment for each patient by adapting it to early response and to treat only those patients with addiotional radiotherapy who show an inadequate treatment response. The degree of treatment response is…
ID
Source
Brief title
Condition
- Lymphomas Hodgkin's disease
- Lymphomas Hodgkin's disease
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Progression Free Survival (PFS)
Secondary outcome
CR rate
Overall survival
late toxicity of treatment
Secondary maligancy rate
Rate of patients who are PET positive and PET negative after to 2 cycles of
ABVD
Background summary
The German Hodgkin Study Group Center (GHSG) in Cologne is responsible for
developing trials to improve the treatment of Hodgkin lymphoma.
Improvements in radiotherapy and the introduction of polychemotherapy have
contributed to the development of an incurable malignant disease into an
oncological disease in adults that actually has the best prognosis of all.
Relevant improvements in diagnostics and treatment are based on a stringent
implementation of quality standards in the areas of pathology, radiology,
nuclear medicine, radiotherapy
and chemotherapy.
Due to its superior tumor control and low toxicity level, ABVD is the GHSG*s
standard regimen for early stage HL patients. The question whether 2 x ABVD is
equivalent to 2 x AVD cannot be answered until the final analysis of the HD13
trial has been drawn up. Due to the results of the HD10 trial, 20Gy IF-RT is
the new standard within the scope of clinical trials. If the final analysis of
HD13 reveals that 2 x ABVD is equivalent to 2 x AVD, also this new standard
would possibly be implemented into this trial.
Study objective
The aim of the trial is to individualize treatment for each patient by adapting
it to early response and to treat only those patients with addiotional
radiotherapy who show an inadequate treatment response.
The degree of treatment response is determined by means of FDG-PET after 2
cycles of ABVD.
The aim for patients who show a good response is to reduce the toxicity of
therapy without impairing treatment results.
With this trial it is to be confirmed that the experimental arm (2x ABVD with
or without radiotherapy) is non-inferior to standard treatment ( 2x ABVD plus
20 Gy radiotherapy) with respect to the primary endpoint of PFS.
Study design
Prospective, randomized multicenter study with treatment stratification by
means of FDGPET-scan performed after 2 courses of chemotherapy.
In the HD16 trial, early response after 2 cycles of chemotherapy is examined by
means of FDG-PET. Patients who are randomized into the standard arm receive
IF-RT (20 Gy), independent of their PET-2 result. Patients who are randomized
into the experimental arm receive IF-RT (20 Gy) in case of a positive PET
result (PET-2 positive). Patients with a negative PET (PET-2 negative) don't
receive any further treatment.
The randomization result will not be disclosed until the results of the
restaging examinations and the FDG-PET assessment by the central PET panel have
been established.
Intervention
For PET-2 negative patients: end of treatment
For PET-2 positive patients: 20 Gy Involved Field Radiotherapy
Study burden and risks
Not applicable.
de Boelelaan 1117
Amsterdam 1081 HV
NL
de Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
1.Histologically proven primary diagnosis of Hodgkin lymphoma;
2. Stage: I and II without risk factor
3. Patient had no previous treatment for HL;
4. Age at entry: 18 - 75 years;
5. 6. Normal organ function (except HL-related);
6. Negative HIV test
7. In women: negative pregnancy test
8. Life expectancy > 3 months
Exclusion criteria
1. Incomplete diagnosis of the disease stage;
2. Prior or concurrent disease that prevents treatment according to protocol;
3. HL as composite lymphoma;
4. Prior chemotherapy or radiation;
5. Malignant disease within the last 5 years (exceptions: basalioma, carcinoma in
situ of the cervix uteri, completely resected melanoma TNMpT1);
6. Pregnancy, lactation;
7. WHO activity index > 2;
8. Long-term administration of corticosteroids (e.g. for chronic polyarthritis) or
antineoplastic drugs (e.g. methotrexate)
9. Non-compliance
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR200700447424-NL |
| ClinicalTrials.gov | NCT00736320 |
| CCMO | NL32169.029.10 |