Lymphoma, T-CellPhase 2NCT00418535
Clinical Study of Chemoradiation Followed by VIPD in Nasal Natural Killer (NK)/T-cell Lymphoma
A Phase 2 study testing Concurrent Radiotherapy (RT)/cisplatin, VIPD in people with Lymphoma, T-Cell, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Nasal NK/T-cell lymphoma is a peculiar clinico-pathologic subtype of non-Hodgkin's lymphoma (NHL). Although most patients present with stage I/II, only 30-60% of the patients remain disease-free. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lymphoma, T-Cell
- What is being tested?
- Concurrent Radiotherapy (RT)/cisplatin, VIPD
- How many people
- Not given
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2006to Jul 2009
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed NK/T-cell lymphoma
- Localized (Ann Arbor stage I/II) disease
- At least one measurable lesion
- Age > 18
- ECOG performance status 0 - 2
- Expected life span of at least 12 weeks
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- Normal marrow function (hemoglobin ≥ 9.0 g/dL; absolute neutrophil count ≥ 1,500/mm3; platelet count ≥ 100,000/mm3)
- Normal liver function (total bilirubin < 2x upper limit of normal [ULN], transaminase < 3x ULN)
- Normal renal function (serum creatinine ≤ 1.5 mg/dL, creatinine clearance ≥ 50 mL/min)
- Written informed consent
Who cannot join
- Other malignancies except for treated non-melanoma skin cancers and cervical cancer in situ
- Serious medical illnesses (congestive heart failure, angina, respiratory failure, and renal failure)
- Acute or active infection requiring intravenous (IV) antibiotics
- Pregnant, lactating women
- Previous history of chemotherapy or radiotherapy
- Concomitant medication that may influence the study drugs
- Allergic reaction to study drugs
- Grade 2 or greater peripheral neuropathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Concurrent Chemoradiation Followed by VIPD (Etoposide/Ifosfamide/Cisplatin/Dexamethasone) in Stage I, II Nasal NK/T-cell Lymphoma
Nasal NK/T-cell lymphoma is a peculiar clinico-pathologic subtype of non-Hodgkin's lymphoma (NHL). Although most patients present with stage I/II, only 30-60% of the patients remain disease-free. The efficacy of the conventional anthracycline-based chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone [CHOPP]) has been unsatisfactory.
The optimal treatment of localized NK/T-cell lymphoma has not been defined yet. The optimal dose, sequence, and multi-modality treatment with involved field radiotherapy still need to be refined. This trial is to evaluate the efficacy of concurrent chemoradiotherapy with cisplatin followed by VIPD (etoposide, ifosfamide, cisplatin, dexamethasone) in localized NK/T-cell lymphoma patients.
- Conditions
- Lymphoma, T-Cell
- Being tested
- Concurrent Radiotherapy (RT)/cisplatin, VIPD
- Keywords
- Lymphoma, NK/T-Cell
- Medical subject headings
- Lymphoma, T-Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent Radiotherapy (RT)/cisplatin, VIPDDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2007 (estimated)
- Study startApr 2006
- Primary completionMar 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, T-CellStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Korea University Anam Hospital, Asan Medical Center, Gyeongsang National University Hospital
- Investigators
- Won Seog Kim, MD, Ph.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00418535
- Sponsor's protocol ID
- 2004-10-08
- Status last verified
- Jan 2007
- First submitted
- 3 Jan 2007
- Last updated
- 21 Oct 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Concurrent Chemoradiation Followed by VIPD (Etoposide/Ifosfamide/Cisplatin/Dexamethasone) in Stage I, II Nasal NK/T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT00418535
- Acronym / sponsor ID
- 2004-10-08
- Conditions
- Lymphoma, T-Cell
- Keywords
- Lymphoma, NK/T-Cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Korea University Anam Hospital, Asan Medical Center, Gyeongsang National University Hospital
- Study start
- Apr 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 5 Jan 2007 (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.
Nasal NK/T-cell lymphoma is a peculiar clinico-pathologic subtype of non-Hodgkin's lymphoma (NHL). Although most patients present with stage I/II, only 30-60% of the patients remain disease-free. The efficacy of the conventional anthracycline-based chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone [CHOPP]) has been unsatisfactory.
The optimal treatment of localized NK/T-cell lymphoma has not been defined yet. The optimal dose, sequence, and multi-modality treatment with involved field radiotherapy still need to be refined. This trial is to evaluate the efficacy of concurrent chemoradiotherapy with cisplatin followed by VIPD (etoposide, ifosfamide, cisplatin, dexamethasone) in localized NK/T-cell lymphoma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pathologically confirmed NK/T-cell lymphoma
- Localized (Ann Arbor stage I/II) disease
- At least one measurable lesion
- Age > 18
- ECOG performance status 0 - 2
Key exclusion criteria (8 listed)
- Other malignancies except for treated non-melanoma skin cancers and cervical cancer in situ
- Serious medical illnesses (congestive heart failure, angina, respiratory failure, and renal failure)
- Acute or active infection requiring intravenous (IV) antibiotics
- Pregnant, lactating women
- Previous history of chemotherapy or radiotherapy
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 |
|---|---|---|
| Concurrent Radiotherapy (RT)/cisplatin, VIPD | Drug | – |
Primary outcome
Not reported in the source record.
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 21 Oct 2009.
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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.
Won Seog Kim, MD, Ph.D principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Concurrent Radiotherapy (RT)/cisplatin, VIPD in people with Lymphoma, T-Cell, run by Samsung Medical Center at 1 site in South Korea.
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 10 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 21 Oct 2009. 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 South Korea. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
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 21 Oct 2009.