Extranodal NK-T-CELL LYMPHOMAPhase 2Gifox-BNCT02808091
Bortezomib With Combination of Gemcitabine, Ifosfamide and Oxaliplatin in Untreated NK/T Cell Lymphoma
A Phase 2 study testing GIFOX-Bortezomib and IMRT in people with Extranodal NK-T-CELL LYMPHOMA, run by National Cancer Centre, Singapore at 1 site in Singapore.
Trial summary
Assess responses, progression free survival (PFS) and overall survival (OS) of the combination of GIFOX-B chemotherapy with intensity-modulated radiation therapy (IMRT) in Stage IB or bulky disease - II and without IMRT in Stage III - IV. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Extranodal NK-T-CELL LYMPHOMA
- What is being tested?
- GIFOX-Bortezomib and IMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSingapore
- Study dates
- Mar 2011to Mar 2014
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Extranodal NK/T-cell lymphomas
- Confirmed pathological diagnosis by the Department of Pathology SGH/NUH/TTSH.
- Age more than or equals to 21 years.
- Stages IB or bulky disease, II - IV
- ECOG performance 0-2
- Laboratory tests: ANC more than or equals to 1000/mm3, platelet more than or equals to 75,000/mm3. Creatinine less than or equals to 2x ULN or creatinine clearance more than or equals to 50 ml/min; AST and ALT less than or equals to 3x ULN. Total bilirubin < 1.5x ULN except < 3x ULN in patients with Gilbert's (as defined as > 80% unconjugated hyperbilirubinemia without other known cause); unless impairment is due to organ involvement by lymphoma.
- Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- Had prior systemic chemotherapy. Patients may be entered if they have had prior limited-field radiotherapy or a short course of glucocorticoids or single agent chemotherapy for an urgent local problem at diagnosis (e.g. epidural cord compression, superior vena caval syndrome).
- History of peripheral neuropathy
- HIV positive
- Presence of CNS disease
- Hypersensitivity to bortezomib, boron, or mannitol
- Contraindication to any cytotoxic drug contained in the chemotherapy regimen.
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- Female subject of child-bearing potential not willing to use an acceptable method of birth control (i.e. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and one year beyond treatment completion.
- Female subject pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum β-human chorionic gonadotrophin (β-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for women without child-bearing potential.
- Invasive or active malignancy in past 2 years.
- Serious concomitant medical illnesses that would jeopardize the patient's ability to receive the regimen with reasonable safety.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial of Bortezomib With Combination of Gemcitabine, Ifosfamide and Oxaliplatin (GIFOX-B)in Untreated NK/T Cell Lymphoma
- Assess responses, progression free survival (PFS) and overall survival (OS) of the combination of GIFOX-B chemotherapy with intensity-modulated radiation therapy (IMRT) in Stage IB or bulky disease - II and without IMRT in Stage III - IV.
- Assess the toxicity and maximum tolerated dose of bortezomib administered in combination with GIFOX chemotherapy.
- Conditions
- Extranodal NK-T-CELL LYMPHOMA
- Being tested
- GIFOX-Bortezomib, IMRT
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIFOX-BortezomibDrug
GIFOX-Bortezomib will be given every 21 days for 4 cycles
GIFOX-BortezomibDrug
GIFOX-Bortezomib will be given every 21 days for a total of 6 cycles.
IMRTRadiation
Also called Intensity-modulated radiation therapy
a minimum of 50 Gy of IMRT to tumor bed and neck (5 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Early stage (IB or bulky disease - II) | Experimental | who will receive GIFOX-B chemotherapy followed by involved field radiotherapy. Receives: Drug: GIFOX-Bortezomib; Radiation: IMRT |
| Advanced stage (III - IV) | Experimental | will receive only chemotherapy alone Receives: Drug: GIFOX-Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rates of bortezomib in combination with GIFOX (GIFOX-B) chemotherapy with or without intensity-modulated radiation therapy (IMRT)
Assess the response rates of bortezomib in combination with GIFOX (GIFOX-B) chemotherapy together with intensity-modulated radiation therapy (IMRT) in stage IB or bulky disease - II patients and chemotherapy alone in stage III - IV patients.
Measured: 3 years
Secondary outcomes (3)
Progression free survival (PFS) of the combination of GIFOX-B chemotherapy with IMRT in stage IB and III - IV patients
Measured: 3 years
Overall survival (OS) of the combination of GIFOX-B chemotherapy with IMRT in stage IB and III - IV patients
Measured: 5 years
Toxicity of bortezomib administered in combination with GIFOX chemotherapy
Access the toxicity of treatment according to CTC AE 4.0
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startMar 2011
- Primary completionNov 2013
- Study completionMar 2014
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extranodal NK-T-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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Soon Thye LIM, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808091
- Sponsor's protocol ID
- NCC1004
- Acronym
- Gifox-B
- Status last verified
- Sep 2016
- First submitted
- 9 Jun 2016
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Bortezomib With Combination of Gemcitabine, Ifosfamide and Oxaliplatin (GIFOX-B)in Untreated NK/T Cell Lymphoma
- ClinicalTrials.gov ID
- NCT02808091
- Acronym / sponsor ID
- Gifox-B / NCC1004
- Conditions
- Extranodal NK-T-CELL LYMPHOMA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 21 Jun 2016 (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.
- Assess responses, progression free survival (PFS) and overall survival (OS) of the combination of GIFOX-B chemotherapy with intensity-modulated radiation therapy (IMRT) in Stage IB or bulky disease - II and without IMRT in Stage III - IV.
- Assess the toxicity and maximum tolerated dose of bortezomib administered in combination with GIFOX chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early stage (IB or bulky disease - II) | Experimental | Drug: GIFOX-Bortezomib, Radiation: IMRTwho will receive GIFOX-B chemotherapy followed by involved field radiotherapy. |
| Advanced stage (III - IV) | Experimental | Drug: GIFOX-Bortezomibwill receive only chemotherapy alone |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Extranodal NK/T-cell lymphomas
- Confirmed pathological diagnosis by the Department of Pathology SGH/NUH/TTSH.
- Age more than or equals to 21 years.
- Stages IB or bulky disease, II - IV
- ECOG performance 0-2
Key exclusion criteria (10 listed)
- Had prior systemic chemotherapy. Patients may be entered if they have had prior limited-field radiotherapy or a short course of glucocorticoids or single agent chemotherapy for an urgent local problem at diagnosis (e.g. epidural cord compression, superior vena caval syndrome).
- History of peripheral neuropathy
- HIV positive
- Presence of CNS disease
- Hypersensitivity to bortezomib, boron, or mannitol
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 |
|---|---|---|
| GIFOX-BortezomibGIFOX-Bortezomib will be given every 21 days for 4 cycles | Drug | Early stage (IB or bulky disease - II) |
| GIFOX-BortezomibGIFOX-Bortezomib will be given every 21 days for a total of 6 cycles. | Drug | Advanced stage (III - IV) |
| IMRTAlso: Intensity-modulated radiation therapya minimum of 50 Gy of IMRT to tumor bed and neck (5 weeks) | Radiation | Early stage (IB or bulky disease - II) |
Primary outcome
Response rates of bortezomib in combination with GIFOX (GIFOX-B) chemotherapy with or without intensity-modulated radiation therapy (IMRT)
Time frame: 3 years
Assess the response rates of bortezomib in combination with GIFOX (GIFOX-B) chemotherapy together with intensity-modulated radiation therapy (IMRT) in stage IB or bulky disease - II patients and chemotherapy alone in stage III - IV patients.
3 secondary outcomes
Progression free survival (PFS) of the combination of GIFOX-B chemotherapy with IMRT in stage IB and III - IV patients
Time frame: 3 years
Overall survival (OS) of the combination of GIFOX-B chemotherapy with IMRT in stage IB and III - IV patients
Time frame: 5 years
Toxicity of bortezomib administered in combination with GIFOX chemotherapy
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2016.
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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.
Soon Thye LIM principal investigator
National Cancer Centre, Singapore
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 GIFOX-Bortezomib and IMRT in people with Extranodal NK-T-CELL LYMPHOMA, run by National Cancer Centre, Singapore at 1 site in Singapore.
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 10 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: stopped early, as of the sponsor's last update on 5 Sep 2016. 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 Singapore. 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 was stopped early (reason given: Slow recruitment). Results are not available in the source record.
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?
Response rates of bortezomib in combination with GIFOX (GIFOX-B) chemotherapy with or without intensity-modulated radiation therapy (IMRT) (time frame: 3 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 5 Sep 2016.