Diffuse Large B-cell LymphomaPhase 3NCT02449278
The Palliative Benefit of Involved-site Radiotherapy for Patients With Advanced-stage Diffuse Large B-cell Lymphoma
A Phase 3 study testing Consolidation involved-site radiotherapy (ISRT), Consolidation involved-field radiotherapy (IFRT) and cyclophosphamide in people with Diffuse Large B-cell Lymphoma, run by Wuhan University at 1 site in China.
Trial summary
The standard treatment approach for patients with stage III-IV DLBCL is combination chemotherapy. Receipt of consolidation radiotherapy (RT) after effective chemotherapy was associated with improved in-field control and event-free survival. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- What is being tested?
- Consolidation involved-site radiotherapy (ISRT), Consolidation involved-field radiotherapy (IFRT) and cyclophosphamide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Oct 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both male and female aged range from 18 years to 65 years.
- Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1.
- All patients had histologically confirmed Diffuse large B-cell lymphoma.
- Advanced-stage DLBCL patients at newly diagnosed or recurrent without RT in initial management.
- Adequate organ function.
- Negative pregnancy test.
- Signed informed consent document on file.
Who cannot join
- Woman who were pregnant or lactating.
- With severe local infection or general infective disease.
- Primary lymphoma in special organ including cuticula, center never system, gastrointestinal tract, testicle, and lung.
- With other second primary malignancy except cutaneum carcinoma.
- Being or planning to participate in other study.
- Any patient who in the opinion of the investigator should not participate in the study.
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- Withdrawal Criteria:
- Patient are free to withdrawal completely from the study at any time upon request.
- Patient in the study may be stopped with the patient agreement at any time at the discretion of investigator.
- In-field progression on irradiation ongoing.
- Poor tolerability adverse events in the period of chemotherapy or irradiation after enrolled in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Palliative Benefit of Involved-site Radiotherapy Following Effective Chemotherapy for Patients With Advanced-stage Diffuse Large B-cell Lymphoma: Wuhan University Cancer Center - NHL04 Trial
The standard treatment approach for patients with stage III-IV DLBCL is combination chemotherapy. Receipt of consolidation radiotherapy (RT) after effective chemotherapy was associated with improved in-field control and event-free survival. However, it is uncertain for the radiotherapy field size to treat for these patients after chemotherapy. Involved-field radiotherapy (IFRT) after effective chemotherapy is a common strategy for patients with stage III-IV DLBCL. There is not a clinical trial to research whether the sequential narrowed radiotherapy field size (involved-site radiotherapy, ISRT) can obtain the same efficacy as IFRT and decrease toxicities related to radiotherapy.
Read the detailed description
Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma. Approximately 50% of patients present with stage III-IV disease at diagnosis. The standard treatment approach for these patients is combination chemotherapy. the role of radiation therapy (RT) after effective system therapy in stage III-IV DLBCL (advanced-stage DLBCL) is controversial. The recommended approaches for patients with stage III-IV disease by The National Comprehensive Cancer Network (NCCN) are that consolidation RT is managed for patients who achieved a complete response (CR) to chemotherapy and palliative RT for patients with partial response (PR) after chemotherapy. However, it is uncertain for the radiotherapy field size to treat for these patients after chemotherapy.
Some benefits of consolidation RT after chemotherapy exist for patients with advanced-stage DLBCL. One of the important aims of treatment for these patients is the improvement of event-free survival (EFS). After patients receive chemotherapy alone, the most common site of disease recurrence is at sites of initial disease involvement. The complications related to chemotherapy, including second malignancies and other non-neoplastic late events, were needed to emphasize for those patients managed with more cycles' regimens alone to increase the efficacy of patients with advanced-stage DLBCL. Receipt of consolidation RT was associated with improved in-field control and EFS though no difference in overall survival (OS) when compared to patients without consolidation RT. Several randomized and retrospective studies demonstrated that the EFS (even the OS) can be improved by consolidation RT for patients with advanced-stage DLBCL after CHOP or CHOP-like chemotherapy. The patients randomized among those diagnosed initially with bulky disease (>10 cm), those achieving CR or PR after chemotherapy, and even those in stage IV with bone marrow involved.
The complications related to consolidation RT also need to be additionally explored for those patients since the efficacy of advanced-stage DLBCL has improved by combined-modality therapy (CMT). Especially, considerable difficulties in the continuous salvage options are unavoidable because of the risk of blood cell production disorders associated to extensive-field radiotherapy. Consolidation involved-field radiotherapy (IFRT) after effective chemotherapy is common palliative strategy for patients with advanced-stage DLBCL. The morbidity of treatment may be decreased further by RT with the radiation field size reduction. Involved-site radiotherapy (ISRT), based on a modified involved field, aims to reduce the radiation volume treated and the probability of late effects. Its radiation targets include a gross tumor volume (GTV), a clinical target volume (CTV), and a planning target volume (PTV), which were defined in International Commission on Radiation Units and Measurements Report (ICRU) 50. This is based on defining the site of gross disease before chemotherapy, the GTV and using a CT-based volume with an expansion to form a CTV in the cranio-caudal direction. There is not a clinical trial to research whether the sequential narrowed radiotherapy field size (involved-site radiotherapy, ISRT) can obtain the same efficacy as IFRT and decrease toxicities related to radiotherapy.
To evaluate the differences between IFRT and ISRT in the efficacy and complications related to consolidation RT for patients with advanced-stage DLBCL who achieved effective chemotherapy. The CTV of ISRT is defined as the region including the prechemotherapy volume of disease with 1.5 cm margin expanded cranio-caudally in the direction of potential lymphatic spread. The CTV should not extend into air in the transverse plane and should be limited in the involved lymph node region defined by the Cancer and Leukemia Group B (CALGB). The PTV is then extended from CTV by adding the necessary margin for setup error and organ motion.
- Conditions
- Diffuse Large B-cell Lymphoma
- Being tested
- Consolidation involved-site radiotherapy (ISRT), Consolidation involved-field radiotherapy (IFRT), cyclophosphamide, doxorubicin, vincristine
- Keywords
- advanced-stage DLBCL, ISRT, chemotherapy
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consolidation involved-site radiotherapy (ISRT)Radiation
6 cycles modern CHOP chemotherapy followed consolidation involved-site radiotherapy (ISRT).
Involved-site radiotherapy (ISRT) is based on defining the site of gross disease before chemotherapy, the GTV and using a CT-based volume with an expansion to form a CTV in the cranio-caudal direction.
The general dose had been guided that 30-36Gy in 15~18 fractions of 2 Gy 5 days per week was managed for patients with complete response (CR) after chemotherapy and 40-50Gy in 20~25 fractions of 2 Gy 5 days per week for partial response (PR).
Consolidation involved-field radiotherapy (IFRT)Radiation
6 cycles modern CHOP chemotherapy followed consolidation involved-field radiotherapy (IFRT).
Radiotherapy field of IFRT defined by CALGB is encompassed the prechemotherapy gross tumor.
The general dose had been guided that 30-36Gy in 15~18 fractions of 2 Gy 5 days per week was managed for patients with complete response (CR) after chemotherapy and 40-50Gy in 20~25 fractions of 2 Gy 5 days per week for partial response (PR).
cyclophosphamideDrug
Patients in both arms will be given cyclophosphamide chemotherapy
doxorubicinDrug
Patients in both arms will be given doxorubicin chemotherapy
vincristineDrug
Patients in both arms will be given vincristine chemotherapy
prednisoneDrug
Patients in both arms will be given prednisone chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| ISRT group | Experimental | Six cycles Chemotherapy (cyclophosphamide 750mg/square meter on day 1 + doxorubicin 50mg/square meter on day 1 + vincristine 1.4mg/square meter on day 1 (up to a maximal dose of 2 mg) + prednisone 60mg/square meter on day 1 through 5, repeated at 21-day intervals) .
Consolidation involved-site radiotherapy (ISRT) following in patient with complete or partial response beginning 1 month after last cycle of chemotherapy. Receives: Radiation: Consolidation involved-site radiotherapy (ISRT); Drug: cyclophosphamide; Drug: doxorubicin; Drug: vincristine; Drug: prednisone |
| IFRT group | Active comparator | Six cycles Chemotherapy (cyclophosphamide 750mg/square meter on day 1 + doxorubicin 50mg/square meter on day 1 + vincristine 1.4mg/square meter on day 1 (up to a maximal dose of 2 mg) + prednisone 60mg/square meter on day 1 through 5, repeated at 21-day intervals).
Consolidation involved-field radiotherapy (IFRT) following in patient with complete or partial response beginning 1 month after last cycle of chemotherapy. Receives: Radiation: Consolidation involved-field radiotherapy (IFRT); Drug: cyclophosphamide; Drug: doxorubicin; Drug: vincristine; Drug: prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival - PFS
Treatment failure was defined as any recurrence of non-Hodgkin lymphoma.
Measured: from the date of diagnosis to the date of treatment failure or death from any cause, whichever occurs first, Assessed up to 100 months.
Adverse events with grade 3 or 4 - AEs
Toxicity was scored according to the toxicity scale of the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0.
Measured: The time from the day of treatment to the day of the first documented disease progression or death from any cause, Assessed up to 24 months.
Secondary outcomes (4)
Overall survival - OS
Measured: From the initial diagnosis of follicular lymphoma to death from any cause, Assessed up to 120 months.
Rate of in-field progression
Measured: From the start of RT to the first documented disease progression within the radiotherapy field, Assessed up to 60 months.
Rate of out-field progression
Measured: From the start of RT to the first documented disease progression outside the radiotherapy field, Assessed up to 60 months.
Rate of regional failure
Measured: From the start of RT to the first documented disease progression outside of ISRT field but within the involved region defined as CALGB, Assessed up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2019 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Di Deng, Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449278
- Sponsor's protocol ID
- WUCC-NHL04 Trial
- Status last verified
- Dec 2015
- First submitted
- 7 May 2015
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Palliative Benefit of Involved-site Radiotherapy Following Effective Chemotherapy for Patients With Advanced-stage Diffuse Large B-cell Lymphoma: Wuhan University Cancer Center - NHL04 Trial
- ClinicalTrials.gov ID
- NCT02449278
- Acronym / sponsor ID
- WUCC-NHL04 Trial
- Conditions
- Diffuse Large B-cell Lymphoma
- Keywords
- advanced-stage DLBCL, ISRT, chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Wuhan UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 20 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The standard treatment approach for patients with stage III-IV DLBCL is combination chemotherapy. Receipt of consolidation radiotherapy (RT) after effective chemotherapy was associated with improved in-field control and event-free survival. However, it is uncertain for the radiotherapy field size to treat for these patients after chemotherapy. Involved-field radiotherapy (IFRT) after effective chemotherapy is a common strategy for patients with stage III-IV DLBCL. There is not a clinical trial to research whether the sequential narrowed radiotherapy field size (involved-site radiotherapy, ISRT) can obtain the same efficacy as IFRT and decrease toxicities related to radiotherapy.
Detailed description
Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma. Approximately 50% of patients present with stage III-IV disease at diagnosis. The standard treatment approach for these patients is combination chemotherapy. the role of radiation therapy (RT) after effective system therapy in stage III-IV DLBCL (advanced-stage DLBCL) is controversial. The recommended approaches for patients with stage III-IV disease by The National Comprehensive Cancer Network (NCCN) are that consolidation RT is managed for patients who achieved a complete response (CR) to chemotherapy and palliative RT for patients with partial response (PR) after chemotherapy. However, it is uncertain for the radiotherapy field size to treat for these patients after chemotherapy.
Some benefits of consolidation RT after chemotherapy exist for patients with advanced-stage DLBCL. One of the important aims of treatment for these patients is the improvement of event-free survival (EFS). After patients receive chemotherapy alone, the most common site of disease recurrence is at sites of initial disease involvement. The complications related to chemotherapy, including second malignancies and other non-neoplastic late events, were needed to emphasize for those patients managed with more cycles' regimens alone to increase the efficacy of patients with advanced-stage DLBCL. Receipt of consolidation RT was associated with improved in-field control and EFS though no difference in overall survival (OS) when compared to patients without consolidation RT. Several randomized and retrospective studies demonstrated that the EFS (even the OS) can be improved by consolidation RT for patients with advanced-stage DLBCL after CHOP or CHOP-like chemotherapy. The patients randomized among those diagnosed initially with bulky disease (>10 cm), those achieving CR or PR after chemotherapy, and even those in stage IV with bone marrow involved.
The complications related to consolidation RT also need to be additionally explored for those patients since the efficacy of advanced-stage DLBCL has improved by combined-modality therapy (CMT). Especially, considerable difficulties in the continuous salvage options are unavoidable because of the risk of blood cell production disorders associated to extensive-field radiotherapy. Consolidation involved-field radiotherapy (IFRT) after effective chemotherapy is common palliative strategy for patients with advanced-stage DLBCL. The morbidity of treatment may be decreased further by RT with the radiation field size reduction. Involved-site radiotherapy (ISRT), based on a modified involved field, aims to reduce the radiation volume treated and the probability of late effects. Its radiation targets include a gross tumor volume (GTV), a clinical target volume (CTV), and a planning target volume (PTV), which were defined in International Commission on Radiation Units and Measurements Report (ICRU) 50. This is based on defining the site of gross disease before chemotherapy, the GTV and using a CT-based volume with an expansion to form a CTV in the cranio-caudal direction. There is not a clinical trial to research whether the sequential narrowed radiotherapy field size (involved-site radiotherapy, ISRT) can obtain the same efficacy as IFRT and decrease toxicities related to radiotherapy.
To evaluate the differences between IFRT and ISRT in the efficacy and complications related to consolidation RT for patients with advanced-stage DLBCL who achieved effective chemotherapy. The CTV of ISRT is defined as the region including the prechemotherapy volume of disease with 1.5 cm margin expanded cranio-caudally in the direction of potential lymphatic spread. The CTV should not extend into air in the transverse plane and should be limited in the involved lymph node region defined by the Cancer and Leukemia Group B (CALGB). The PTV is then extended from CTV by adding the necessary margin for setup error and organ motion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ISRT group | Experimental | Radiation: Consolidation involved-site radiotherapy (ISRT), Drug: cyclophosphamide, Drug: doxorubicin, Drug: vincristine, Drug: prednisoneSix cycles Chemotherapy (cyclophosphamide 750mg/square meter on day 1 + doxorubicin 50mg/square meter on day 1 + vincristine 1.4mg/square meter on day 1 (up to a maximal dose of 2 mg) + prednisone 60mg/square meter on day 1 through 5, repeated at 21-day intervals) . Consolidation involved-site radiotherapy (ISRT) following in patient with complete or partial response beginning 1 month after last cycle of chemotherapy. |
| IFRT group | Active comparator | Radiation: Consolidation involved-field radiotherapy (IFRT), Drug: cyclophosphamide, Drug: doxorubicin, Drug: vincristine, Drug: prednisoneSix cycles Chemotherapy (cyclophosphamide 750mg/square meter on day 1 + doxorubicin 50mg/square meter on day 1 + vincristine 1.4mg/square meter on day 1 (up to a maximal dose of 2 mg) + prednisone 60mg/square meter on day 1 through 5, repeated at 21-day intervals). Consolidation involved-field radiotherapy (IFRT) following in patient with complete or partial response beginning 1 month after last cycle of chemotherapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Both male and female aged range from 18 years to 65 years.
- Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1.
- All patients had histologically confirmed Diffuse large B-cell lymphoma.
- Advanced-stage DLBCL patients at newly diagnosed or recurrent without RT in initial management.
- Adequate organ function.
Key exclusion criteria (11 listed)
- Woman who were pregnant or lactating.
- With severe local infection or general infective disease.
- Primary lymphoma in special organ including cuticula, center never system, gastrointestinal tract, testicle, and lung.
- With other second primary malignancy except cutaneum carcinoma.
- Being or planning to participate in other study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Consolidation involved-site radiotherapy (ISRT)6 cycles modern CHOP chemotherapy followed consolidation involved-site radiotherapy (ISRT). Involved-site radiotherapy (ISRT) is based on defining the site of gross disease before chemotherapy, the GTV and using a CT-based volume with an expansion to form a CTV in the cranio-caudal direction. The general dose had been guided that 30-36Gy in 15~18 fractions of 2 Gy 5 days per week was managed for patients with complete response (CR) after chemotherapy and 40-50Gy in 20~25 fractions of 2 Gy 5 days per week for partial response (PR). | Radiation | ISRT group |
| Consolidation involved-field radiotherapy (IFRT)6 cycles modern CHOP chemotherapy followed consolidation involved-field radiotherapy (IFRT). Radiotherapy field of IFRT defined by CALGB is encompassed the prechemotherapy gross tumor. The general dose had been guided that 30-36Gy in 15~18 fractions of 2 Gy 5 days per week was managed for patients with complete response (CR) after chemotherapy and 40-50Gy in 20~25 fractions of 2 Gy 5 days per week for partial response (PR). | Radiation | IFRT group |
| cyclophosphamidePatients in both arms will be given cyclophosphamide chemotherapy | Drug | IFRT group, ISRT group |
| doxorubicinPatients in both arms will be given doxorubicin chemotherapy | Drug | IFRT group, ISRT group |
| vincristinePatients in both arms will be given vincristine chemotherapy | Drug | IFRT group, ISRT group |
| prednisonePatients in both arms will be given prednisone chemotherapy | Drug | IFRT group, ISRT group |
Primary outcome
Progression-free survival - PFS
Time frame: from the date of diagnosis to the date of treatment failure or death from any cause, whichever occurs first, Assessed up to 100 months.
Treatment failure was defined as any recurrence of non-Hodgkin lymphoma.
Adverse events with grade 3 or 4 - AEs
Time frame: The time from the day of treatment to the day of the first documented disease progression or death from any cause, Assessed up to 24 months.
Toxicity was scored according to the toxicity scale of the National Cancer Institute Common Terminology Criteria for Adverse Events 3.0.
4 secondary outcomes
Overall survival - OS
Time frame: From the initial diagnosis of follicular lymphoma to death from any cause, Assessed up to 120 months.
Rate of in-field progression
Time frame: From the start of RT to the first documented disease progression within the radiotherapy field, Assessed up to 60 months.
Rate of out-field progression
Time frame: From the start of RT to the first documented disease progression outside the radiotherapy field, Assessed up to 60 months.
Rate of regional failure
Time frame: From the start of RT to the first documented disease progression outside of ISRT field but within the involved region defined as CALGB, Assessed up to 60 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Consolidation involved-site radiotherapy (ISRT), Consolidation involved-field radiotherapy (IFRT) and cyclophosphamide in people with Diffuse Large B-cell Lymphoma, run by Wuhan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Di Deng, MD (0086-27-67813153, dengdi69@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival - PFS (time frame: from the date of diagnosis to the date of treatment failure or death from any cause, whichever occurs first, Assessed up to 100 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2015.