Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00292695
Status:
COMPLETED
Last Update Posted:
2013-10-30
First Post:
2006-02-15
Brief Title:
A Phase II Study of Nasal NKT-cell Lymphoma
Sponsor:
National Health Research Institutes Taiwan
Organization:
National Health Research Institutes Taiwan
Study Overview
Official Title:
A Phase II Study of Concurrent Chemoradiation for The Localized Nasal NKT-cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine whether adding combinational chemotherapy concurrently to conventional radiation will improve the response rate event-free survival and overall survival
To test the dose intensity and toxicity of chemotherapy in concurrence with radiation
To detect the blood EBV DNA level in Chinese Nasal NKT-cell lymphoma patients and correlate to the treatment response and prognosis
To test the dose intensity and toxicity of chemotherapy in concurrence with radiation
To detect the blood EBV DNA level in Chinese Nasal NKT-cell lymphoma patients and correlate to the treatment response and prognosis
Detailed Description:
Inclusion Criteria
1 Histologically proven extranodal NKT-cell lymphoma nasal type according to the WHO classification must be pathology-proven EBV DNA positive as well as cytoplasmic CD3 while CD56 is not an essential diagnostic criteria Both newly diagnosed patients and who were previous chemotherapy-treated patients with residual or recurrent diseases will be allowed
2 Any of lymphomatous involvement exist in nasal cavity andor paranasal sinuses orbit Waldeyers ring and oral cavity PS with ECOG scale 0-2
3 Stage I or contiguous stage II measurable or evaluable lymphoma by clinical imaging No previous chemotherapy andor radiotherapy
4 ANC 2000mm3 Platelet 100000mm3 of peripheral blood
5 Age 70
6 Total bilirubin 25 mgdl Serum creatinine 15 mgdl Blood urea nitrogen BUN 25 mgdl
7 Signed informed consent
Exclusion criteria
1 Pregnancy or lactation period
2 Severe intercurrent illness eg infection heart failure
3 Myocardial infarction within recent 12 months
4 Known hypersensitivity to any component drug of the treatment regimen
TREATMENT PLAN
Concurrent chemoradiation is the primary treatment The treatment will be started within 2 weeks after registration The patients are intended to receive the complete radiation dose 50 Gy and 2 courses of DEP regimen concurrently The first course of DEP regimen must be started within one week before or after the initiation of radiation 1st week The second course of DEP regimen will be given in 4 weeks ie the 5th week after completion of the first course of DEP and during the period of radiotherapy The first evaluation of response by CT or MRI will be performed at 4 weeks after the completion of the second course DEP ie the 9th week If patients respond to therapy or remain in the SD situation DVIP regimen will be followed immediately every 4 weeks for another 2 courses as a consolidation therapy If patients are progressive study treatment will be stopped and patients will be off-studied And they will proceed to salvage therapy with DHAP regimen for ethical reason The second evaluation of response will be performed in 4 weeks after completion of treatment ie 21st week
1 Systemic chemotherapy with DEP and DVIP regimens
Schedule and Dose for DEP q4w CCRT Dexamethosone 20 mgm2d iv Day 1-3 VP-16 75 mgm2d iv 1h Day 1-3 cisplatin 75 mgm2d iv 4h Day 1
11 Courses will be repeated every 28 days for total 2 courses 12 The first and second course will be performed concurrently with radiotherapy
13 The first course of DEP regimen must be started within one week before or after the initiation of radiation 1st week
14 The H3-antagonist is permitted for anti-emetic use 15 G-CSF is allowed to be used prophylactically for older 60 years old patients and for patients with previous or ongoing prolonged myelosuppression
Schedule and Dose for DVIP q4w post RT Dexamethosone 20 mgm2d iv Day 1-4 VP-16 75 mgm2d iv 1h Day 1-4 ifosfamide 12 mgm2d iv 2h Day 1-4 mesna 240 mgm2d iv at 048 hr Day 1-4 cisplatin 20 mgm2d iv 1h Day 1-4
16 Courses will be repeated every 28 days for total 2 courses 17 The first course will be performed on the 9th week after the first evaluation of response by CT or MRI
18 The H3-antagonist is permitted for anti-emetic use 19 G-CSF is allowed to be used prophylactically for older 60 years old patients and for patients with previous or ongoing prolonged myelosuppression
2 Involved field radiotherapy Guidelines-
21 General Guidelines Local radiation will be given concurrently with chemotherapy from the beginning of treatment Radiation will be given to the involved field only
1 Equipment- Only megavoltage equipment with source skin distance of 80 cm or greater will be used with SAD technique The treatment cannot be given via electron beam alone even if the lesion is only superficial
2 Cessation of RT- when any condition of
1 Grade 4 mucositis with progression
2 Grade 4 dermatitis in the RT field with progression
3 WBC less than 2000mm3
4 Infection which is potentially life threatening
3 Re-start of RT If toxicity subsides or infection is controlled
22 Target Volume
Gross Tumor Volume GTV The GTV is defined as the volume of tumor at presentation as defined by CT MRI Uninvolved draining regions are not covered The treatment cannot be given via electron beam alone even if the lesion is superficial In cases where there is discrepancy between the scans the larger volume will be irradiated
Clinical Target Volume CTV This is defined as the GTV with a 15cm margin Include ethmoid sinus and medial half of the maxillary sinus into CTV when gross tumor is located within the nasal cavity If ethmoid sinus is extensively involved but there is no clinical or radiographic evidence of orbital involvement the medial bony boundary of the orbit is usually irradiated for possible microscopic disease extension
Planning Target Volume PTV For the purpose of this study a margin for set up error or patient movement is to be added to the CTV This may vary but must be at least 05cm
CRITERIA FOR WITHDRAWAL FROM STUDY All patients who are still under or have completed protocol treatments should be continuously followed-up for all study end points Patients are removed from study if they have completed the protocol or major violations
1 Completion of assigned therapy and observation
2 Disease progression
3 Excessive complication or toxicity
4 Patient death
5 Patient withdrawal or refusal
6 Serum creatinine30 mgdl
7 Any grade III toxicity persists 3 wks after the due day
1 Histologically proven extranodal NKT-cell lymphoma nasal type according to the WHO classification must be pathology-proven EBV DNA positive as well as cytoplasmic CD3 while CD56 is not an essential diagnostic criteria Both newly diagnosed patients and who were previous chemotherapy-treated patients with residual or recurrent diseases will be allowed
2 Any of lymphomatous involvement exist in nasal cavity andor paranasal sinuses orbit Waldeyers ring and oral cavity PS with ECOG scale 0-2
3 Stage I or contiguous stage II measurable or evaluable lymphoma by clinical imaging No previous chemotherapy andor radiotherapy
4 ANC 2000mm3 Platelet 100000mm3 of peripheral blood
5 Age 70
6 Total bilirubin 25 mgdl Serum creatinine 15 mgdl Blood urea nitrogen BUN 25 mgdl
7 Signed informed consent
Exclusion criteria
1 Pregnancy or lactation period
2 Severe intercurrent illness eg infection heart failure
3 Myocardial infarction within recent 12 months
4 Known hypersensitivity to any component drug of the treatment regimen
TREATMENT PLAN
Concurrent chemoradiation is the primary treatment The treatment will be started within 2 weeks after registration The patients are intended to receive the complete radiation dose 50 Gy and 2 courses of DEP regimen concurrently The first course of DEP regimen must be started within one week before or after the initiation of radiation 1st week The second course of DEP regimen will be given in 4 weeks ie the 5th week after completion of the first course of DEP and during the period of radiotherapy The first evaluation of response by CT or MRI will be performed at 4 weeks after the completion of the second course DEP ie the 9th week If patients respond to therapy or remain in the SD situation DVIP regimen will be followed immediately every 4 weeks for another 2 courses as a consolidation therapy If patients are progressive study treatment will be stopped and patients will be off-studied And they will proceed to salvage therapy with DHAP regimen for ethical reason The second evaluation of response will be performed in 4 weeks after completion of treatment ie 21st week
1 Systemic chemotherapy with DEP and DVIP regimens
Schedule and Dose for DEP q4w CCRT Dexamethosone 20 mgm2d iv Day 1-3 VP-16 75 mgm2d iv 1h Day 1-3 cisplatin 75 mgm2d iv 4h Day 1
11 Courses will be repeated every 28 days for total 2 courses 12 The first and second course will be performed concurrently with radiotherapy
13 The first course of DEP regimen must be started within one week before or after the initiation of radiation 1st week
14 The H3-antagonist is permitted for anti-emetic use 15 G-CSF is allowed to be used prophylactically for older 60 years old patients and for patients with previous or ongoing prolonged myelosuppression
Schedule and Dose for DVIP q4w post RT Dexamethosone 20 mgm2d iv Day 1-4 VP-16 75 mgm2d iv 1h Day 1-4 ifosfamide 12 mgm2d iv 2h Day 1-4 mesna 240 mgm2d iv at 048 hr Day 1-4 cisplatin 20 mgm2d iv 1h Day 1-4
16 Courses will be repeated every 28 days for total 2 courses 17 The first course will be performed on the 9th week after the first evaluation of response by CT or MRI
18 The H3-antagonist is permitted for anti-emetic use 19 G-CSF is allowed to be used prophylactically for older 60 years old patients and for patients with previous or ongoing prolonged myelosuppression
2 Involved field radiotherapy Guidelines-
21 General Guidelines Local radiation will be given concurrently with chemotherapy from the beginning of treatment Radiation will be given to the involved field only
1 Equipment- Only megavoltage equipment with source skin distance of 80 cm or greater will be used with SAD technique The treatment cannot be given via electron beam alone even if the lesion is only superficial
2 Cessation of RT- when any condition of
1 Grade 4 mucositis with progression
2 Grade 4 dermatitis in the RT field with progression
3 WBC less than 2000mm3
4 Infection which is potentially life threatening
3 Re-start of RT If toxicity subsides or infection is controlled
22 Target Volume
Gross Tumor Volume GTV The GTV is defined as the volume of tumor at presentation as defined by CT MRI Uninvolved draining regions are not covered The treatment cannot be given via electron beam alone even if the lesion is superficial In cases where there is discrepancy between the scans the larger volume will be irradiated
Clinical Target Volume CTV This is defined as the GTV with a 15cm margin Include ethmoid sinus and medial half of the maxillary sinus into CTV when gross tumor is located within the nasal cavity If ethmoid sinus is extensively involved but there is no clinical or radiographic evidence of orbital involvement the medial bony boundary of the orbit is usually irradiated for possible microscopic disease extension
Planning Target Volume PTV For the purpose of this study a margin for set up error or patient movement is to be added to the CTV This may vary but must be at least 05cm
CRITERIA FOR WITHDRAWAL FROM STUDY All patients who are still under or have completed protocol treatments should be continuously followed-up for all study end points Patients are removed from study if they have completed the protocol or major violations
1 Completion of assigned therapy and observation
2 Disease progression
3 Excessive complication or toxicity
4 Patient death
5 Patient withdrawal or refusal
6 Serum creatinine30 mgdl
7 Any grade III toxicity persists 3 wks after the due day
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None