Lymphoma, Large B-cell, DiffusePhase 3NCT01156259
30Gy Versus 40Gy Radiotherapy for Localized Diffuse Large B Cell Lymphoma Achieving CR After Chemotherapy
A Phase 3 study testing Radiotherapy followed by chemotherapy and 3D-CRT based Involved Field Radiotherapy in people with Lymphoma, Large B-cell, Diffuse, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to determine whether 30Gy radiotherapy is as effective as 40Gy in the treatment of localized Diffused Large B cell Lymphoma (DLBCL) when completing CR after chemotherapy. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Lymphoma, Large B-cell, Diffuse
- What is being tested?
- Radiotherapy followed by chemotherapy and 3D-CRT based Involved Field Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 1 siteChina
- Study dates
- 14 Jul 2010to Jul 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written informed consent obtained before any trial-specific procedure.
- Age 15 years or older.
- Newly diagnosed, histologically confirmed DLBCL or primary mediastinal B-cell lymphoma (PMBL).
- Ann Arbor stage I or II disease.
- Complete response after chemotherapy, defined as the absence of clinical or imaging evidence of active disease, or a Deauville score of 1-3 on PET/CT.
- An interval of less than 90 days between completion of chemotherapy and radiotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Able to receive conformal radiotherapy and to complete the required follow-up.
Who cannot join
- HIV seropositivity.
- Primary lymphoma of the central nervous system, skin, or testis.
- Transformation from another indolent lymphoma.
- Previous malignancy other than cervical carcinoma in situ.
- Hepatic or cardiac failure.
- Any concurrent condition precluding protocol treatment.
- Chemotherapy or radiotherapy before trial enrolment.
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
About this study
Official title: Phase 3 Study of 30Gy Versus 40Gy Radiotherapy in Localized Diffuse Large B Cell Lymphoma Achieving CR After Chemotherapy
The purpose of this study is to determine whether 30Gy radiotherapy is as effective as 40Gy in the treatment of localized Diffused Large B cell Lymphoma (DLBCL) when completing CR after chemotherapy.
Read the detailed description
The best proper doses of RT in combined modality treatments (CMT) for localized DLBCL is still undetermined. Existing treatment guidelines recommend 40Gy or above as the standard treatment dosage. However, there were large-scaled clinical trials implying smaller doses such as 30Gy may be equivalent effective. Lowering radiation doses can decrease treatment toxicities and radiotherapy-induced diseases, which has been conformed by HD13 study for Hodgkin's Lymphoma. It may even retain the truth when modern era radiation techniques are involved and especially in patients achieving CR after chemotherapy. A comprehensive, prospective dose-comparing study is needed.
- Conditions
- Lymphoma, Large B-cell, Diffuse
- Being tested
- Radiotherapy followed by chemotherapy, 3D-CRT based Involved Field Radiotherapy
- Keywords
- B cell cll/lymphoma, human
- 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.
Radiotherapy followed by chemotherapyRadiation
CT simulation, 3D-CRT or IMRT techniques, Radiotherapy of 30Gy
3D-CRT based Involved Field RadiotherapyRadiation
CT simulation, 3D-CRT or IMRT techniques, Radiotherapy of 40Gy
| Study group | Role | What they receive |
|---|---|---|
| 30 Gy | Experimental | Not described Receives: Radiation: Radiotherapy followed by chemotherapy |
| 40 Gy | Active comparator | Not described Receives: Radiation: 3D-CRT based Involved Field Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
the time from randomisation to disease progression, relapse, or death from any cause, whichever occurred first
Measured: five years
Secondary outcomes (4)
overall survival
Measured: five years
acute treatment toxicity
Measured: up to 12 weeks
late treatment toxicity
Measured: five years
treatment failure type
freedom from locoregional recurrence (FFLR), distant metastasis-free survival (DMFS)
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study start14 Jul 2010
- Primary completion1 Jul 2019
- Study completionJul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Large B-cell, DiffuseStudies 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
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-Sen University Cancer Center
- Responsible party
- Principal investigator, Shunan Qi, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Yexiong Li, MD, Study director, Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156259
- Sponsor's protocol ID
- CH-LYM-004
- Status last verified
- Apr 2010
- First submitted
- 29 Jun 2010
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of 30Gy Versus 40Gy Radiotherapy in Localized Diffuse Large B Cell Lymphoma Achieving CR After Chemotherapy
- ClinicalTrials.gov ID
- NCT01156259
- Acronym / sponsor ID
- CH-LYM-004
- Conditions
- Lymphoma, Large B-cell, Diffuse
- Keywords
- B cell cll/lymphoma, human
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Sun Yat-Sen University Cancer Center
- Study start
- 14 Jul 2010 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- Jul 2025 (actual)
- First posted
- 2 Jul 2010 (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 purpose of this study is to determine whether 30Gy radiotherapy is as effective as 40Gy in the treatment of localized Diffused Large B cell Lymphoma (DLBCL) when completing CR after chemotherapy.
Detailed description
The best proper doses of RT in combined modality treatments (CMT) for localized DLBCL is still undetermined. Existing treatment guidelines recommend 40Gy or above as the standard treatment dosage. However, there were large-scaled clinical trials implying smaller doses such as 30Gy may be equivalent effective. Lowering radiation doses can decrease treatment toxicities and radiotherapy-induced diseases, which has been conformed by HD13 study for Hodgkin's Lymphoma. It may even retain the truth when modern era radiation techniques are involved and especially in patients achieving CR after chemotherapy. A comprehensive, prospective dose-comparing study is needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 Gy | Experimental | Radiation: Radiotherapy followed by chemotherapy |
| 40 Gy | Active comparator | Radiation: 3D-CRT based Involved Field Radiotherapy |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent obtained before any trial-specific procedure.
- Age 15 years or older.
- Newly diagnosed, histologically confirmed DLBCL or primary mediastinal B-cell lymphoma (PMBL).
- Ann Arbor stage I or II disease.
- Complete response after chemotherapy, defined as the absence of clinical or imaging evidence of active disease, or a Deauville score of 1-3 on PET/CT.
Key exclusion criteria (8 listed)
- HIV seropositivity.
- Primary lymphoma of the central nervous system, skin, or testis.
- Transformation from another indolent lymphoma.
- Previous malignancy other than cervical carcinoma in situ.
- Hepatic or cardiac failure.
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 |
|---|---|---|
| Radiotherapy followed by chemotherapyCT simulation, 3D-CRT or IMRT techniques, Radiotherapy of 30Gy | Radiation | 30 Gy |
| 3D-CRT based Involved Field RadiotherapyCT simulation, 3D-CRT or IMRT techniques, Radiotherapy of 40Gy | Radiation | 40 Gy |
Primary outcome
Progression-free survival (PFS)
Time frame: five years
the time from randomisation to disease progression, relapse, or death from any cause, whichever occurred first
4 secondary outcomes
overall survival
Time frame: five years
acute treatment toxicity
Time frame: up to 12 weeks
late treatment toxicity
Time frame: five years
treatment failure type
Time frame: five years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
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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.
Yexiong Li, MD study director
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
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 Radiotherapy followed by chemotherapy and 3D-CRT based Involved Field Radiotherapy in people with Lymphoma, Large B-cell, Diffuse, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 8 inclusion and 8 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: finished, as of the sponsor's last update on 23 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: five years). 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 23 Oct 2026.