The aim of the trial is to individualize treatment for each patient by adapting it to early response and thus to continue intensive treatment only with those patients wo show an inadequate treatment response.For patients who show a good initial…
ID
Source
Brief title
Condition
- Lymphomas Hodgkin's disease
- Lymphomas Hodgkin's disease
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Progresion Free Survival (PFS).
Secondary outcome
Overall survival
Acute and late toxicity of treatment
Quality of Life
Secondary maligancy rate
CR rate
HL-specific death rate
Prognostic value of the PET-2 examination
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.
The standard treatment for patients with advanced stage is 8 coureses of
escalated BEACOPP chemotherapy every 3 weeks, followed by radiotherapy, when
necessary.
This standard treatment is an intensive and long treatment with both acute and
long term toxicity.
Therefore the GHSG had started this new trial to investigate if the
experimental therapy (4x BEACOPP escalated) for patients who are PET negative
after 2 cycles of chemotherapy is non-inferior to standard treatment with
respect to the primary endpoint of progression free survival.
Also the GHSG investigates if the experimental therapy for patients who are PET
positive after 2 cycles of chemotherapy: standard treatment with Rituximab, is
superior to standard treatment alone.
In July 2011amendement 2: the standard therapy will be 6 courses of BEACOPP
escalated in stead of 8 courses. This was the outcome of the results of the HD
15 study.
Also randomisation for PET-2 positive patients was closed, because inclusion
for arm B has been ended. They have already included the number of patients.
Study objective
The aim of the trial is to individualize treatment for each patient by adapting
it to early response and thus to continue intensive treatment only with those
patients wo show an inadequate treatment response.
For patients who show a good initial response to treatment (PET-2 negative
patients) the primary aim of the trial is to reduce toxicity while maintaining
tumor control.
For patients who show a poor initial response to treatment (PET-2 positive
patients), the primary aim of the trial is to improve PFS by means of adding
Rituximab to treatment.
Study design
Prospective, randomized and unblinded multicenter study with treatment
stratification by means of FDG-PET-scan performed after 2 courses of
chemotherapy.
Intervention
For PET-2 negative patients:
one group with in total 8x escalated BEACOPP cycles (standard arm)
one group with in total 4x escalated BEACOPP cycles (experimental arm)
For PET-2 positive patients:
one group 8x escalated BEACOPP and 30 Gy radiotherapy on residual tumor
(standard arm)
one group 8x escalated BEACOPP with Rituximab and 30 Gy radiotherapy on
residual tumor (experimental arm)
July 2011amendement 2:
For PET-2 negative patients:
one group with in total 6x escalated BEACOPP cycles.
one group with in total 4x escalated BEACOPP cycles.
For PET-2 positive patients: 6x escalated BEACOPP cycles and 30 Gy radiotherapy
on residual tumor.
Study burden and risks
In the experimental arm Rituximab will be added to the treatment in cycle 4 - 8.
This may induce a larger decrease of the serum immunoglobulines. This may
result in a larger risk for infections. In the protocol are described mandatory
measurements to prevent complications.
Amendement 2 is submitted that the experimental arm with Rituximab is closed
because the necessary number of patient has been achieved.
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:
2.1 CS (PS) IIB with one or both of the following risk factors:
a) Large mediastinal mass (><= 1/3 of the maximum transverse diameter of the
thorax),
b) Extranodal lesions (see definition in section 14.3.4);
2.2 CS (PS) III, IV;
3. Patient had no previous treatment for HL;
4. Age at entry: 18 - 60 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 ingestion of corticosteroids (e.g. for chronic polyarthritis) or
antineoplastic drugs (e.g. methotrexate)
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 | EUCTR2007-003187-22-NL |
| Other | ISRTCN 00515554 |
| CCMO | NL25542.029.09 |