CCRT-VIDL: Concomitant Chemo-radiotherapy Plus VIDL Chemotherapy in NK/T-cell Lymphoma

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01007526
• Collaborator: Asan Medical Center (Other), National Cancer Center, Korea (Other), Severance Hospital (Other)
• Enrollment: 31
• Location: 1
• Arm: 1
• Duration (Months): 56
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

This study is to evaluate the efficacy of risk-adapted treatment strategy for stage I/II extranodal NK/T cell lymphoma. The risk stratification is based on the Korean NK prognostic index. Thus, the group I/II will receive concomitant chemoradiation followed by VIDL chemotherapy. The group III/IV will receive high dose-chemotherapy followed by autologous stem cell transplantation after the completion of VIDL chemotherapy.

Condition or Disease	Intervention/Treatment	Phase
NK/T-cell Lymphoma of Nasal Cavity	Other: CCRT followed by VIDL chemotherapy	Phase 2

Detailed Description

1. Concomitant chemo-radiotherapy:

Radiotherapy 36-44 Gy/18-22 fractions

• weekly cisplatin 30 mg/m2 for 4 weeks

1. Rest period: 3 weeks

2. VIDL combination chemotherapy: (total 2 cycles) VP-16 (etoposide) 100mg/m2 I.V. D1-3 Ifosfamide 1.2g/m2 I.V. D1-3 Dexamethasone 40mg/day D1-3 L-asparaginase 4000IU/m2 IM D8, 10, 12, 14, 16, 18, 20 Repeated every 28 days

3. Peripheral blood stem cell mobilization G-CSF 400ug/m2/day or 10ug/kg/day S.C. or I.V. for 4-6 days followed by stem cell collection (Minimum requirement of CD34+ cells > 2×106/kg)

4. High-dose chemotherapy with autologous stem cell transplantation Busulfex 3.2mg/kg/day from day -7 to day -5 Etoposide 400mg/m2/day on day -5, -4 Cyclophosphamide 50mg/kg/day on day -3, -2 Followed by stem cell infusion

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: VIDL (Etoposide, ifosfamide, dexamethasone and L-asparaginase)VIDL (Etoposide, ifosfamide, dexamethasone and L-asparaginase)
• Masking: None (Open Label)
• Masking Description: Concomitant Chemo-radiotherapy Plus VIDL Chemotherapy
• Primary Purpose: Treatment
• Official Title: Open-labeled, Multicenter Phase II Study of Concomitant Chemo-radiotherapy Followed by VIDL Chemotherapy With Risk-based Application of Autologous Stem Cell Transplantation in Stage I/II Extranodal NK/T-cell Lymphoma
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CCRT plus VIDL CCRT followed by VIDL chemotherapy Concomitant chemo-radiotherapy followed by VIDL chemotherapy with risk-based application of autologous stem cell transplantation Patients who are planned to be treated with CCRT plus VIDL chemotherapy and/or autologous stem cell transplantation	Other: CCRT followed by VIDL chemotherapy; CCRT followed by VIDL chemotherapy concomitant chemo-radiotherapy followed by VIDL (VP-16, Ifosfamide, Dexamethasone, L-asparaginase) chemotherapy with risk-based application of autologous stem cell transplantation

Outcome Measures

Primary Outcome Measures

1. Compete Response Rate [Within 3 weeks after the completion fo treatment]

   Response was determined by the revised response criteria for malignant lymphoma (Cheson BD et al. J Clin Oncol. 2007 Feb 10;25(5):579-86.): 1) Complete response 2) Partial response 3) Stable disease 4) Progressive disease

Secondary Outcome Measures

1. Overall Response Rate, Survival, Toxicity [Up to 5 years after the completion of treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients were required to have a biopsy-proven diagnosis of nasal ENKTL

• at least 18 years old

• Ann Arbor stage IE or IIE

• measurable disease

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

• life expectancy greater than 12 weeks

• adequate hematologic (hemoglobin > 9.0 g/dL, absolute neutrophil count > 1,500/uL and platelets > 100,000/uL)

• renal (serum creatinine < 1.5 mg/dL, creatinine clearance > 50 mL/min)

• hepatic (total bilirubin < 2 times of upper limit of normal and aspartate transferase < 3 times of upper limit of normal) function

• Diagnosis of ENKTL is based on the presence of histological features and immunophenotypes compatible with ENKTL (e.g., cytoplasmic CD3+, CD20-, CD56+, positive for cytotoxic molecules, positive for EBV by in situ hybridization).

• Informed consent

Exclusion Criteria:

• prior or concomitant malignant tumors

• any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.

• ENKTL with non-nasal sites such as skin or gastrointestinal tract was excluded even if it is localized.

• Other subtypes of non-Hodgkin lymphoma (NHL), including myeloid/NK cell precursor acute leukemia, blastic NK cell lymphoma/precursor NK cell lymphoblastic leukemia, aggressive NK cell leukemia, and peripheral T cell lymphoma, unspecified, were excluded.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of	135-710

Sponsors and Collaborators

• Samsung Medical Center
• Asan Medical Center
• National Cancer Center, Korea
• Severance Hospital

Investigators

• Principal Investigator: Won Seog Kim, MD, PhD, Samsung Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Won Seog Kim, Professor, Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT01007526
• Other Study ID Numbers: 2008-04-033
• First Posted: Nov 4, 2009
• Last Update Posted: Feb 7, 2019
• Last Verified: Sep 1, 2018

• Keywords provided by Won Seog Kim, Professor, Samsung Medical Center: Extranodal Lymphoma; Natural killer cell; T cell; Radiotherapy; Chemotherapy
• Additional relevant MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral

Study Results

Participant Flow

Recruitment Details	Recruitment between August 2008 and October 2010 Location: University hospital or Institutes

Arm/Group Title	CCRT Plus VIDL
Arm/Group Description	CCRT followed by VIDL chemotherapy Concomitant chemo-radiotherapy followed by VIDL chemotherapy with risk-based application of autologous stem cell transplantation Patients who are planned to be treated with CCRT plus VIDL chemotherapy and/or autologous stem cell transplantation
Period Title: Overall Study
STARTED	31
COMPLETED	31
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	CCRT Plus VIDL
Arm/Group Description	CCRT followed by VIDL chemotherapy Concomitant chemo-radiotherapy followed by VIDL chemotherapy with risk-based application of autologous stem cell transplantation Patients who are planned to be treated with CCRT plus VIDL chemotherapy and/or autologous stem cell transplantation
Overall Participants	31
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	27 87.1%
>=65 years	4 12.9%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.1 (12.7)
Sex: Female, Male (Count of Participants)
Female	11 35.5%
Male	20 64.5%
Region of Enrollment (participants) [Number]
Korea, Republic of	31 100%

Outcome Measures

1. Primary Outcome

Title	Compete Response Rate
Description	Response was determined by the revised response criteria for malignant lymphoma (Cheson BD et al. J Clin Oncol. 2007 Feb 10;25(5):579-86.): 1) Complete response 2) Partial response 3) Stable disease 4) Progressive disease
Time Frame	Within 3 weeks after the completion fo treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CCRT Plus VIDL
Arm/Group Description	CCRT followed by VIDL chemotherapy Concomitant chemo-radiotherapy followed by VIDL chemotherapy with risk-based application of autologous stem cell transplantation Patients who are planned to be treated with CCRT plus VIDL chemotherapy and/or autologous stem cell transplantation
Measure Participants	31
Number [participants]	31 100%

2. Secondary Outcome

Title	Overall Response Rate, Survival, Toxicity
Time Frame	Up to 5 years after the completion of treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	6 months after registration
Adverse Event Reporting Description	We applied the same definition as the clinicaltrials.gov.
Arm/Group Title	CCRT Plus VIDL
Arm/Group Description	CCRT followed by VIDL chemotherapy Concomitant chemo-radiotherapy followed by VIDL chemotherapy with risk-based application of autologous stem cell transplantation Patients who are planned to be treated with CCRT plus VIDL chemotherapy and/or autologous stem cell transplantation
All Cause Mortality
	CCRT Plus VIDL
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	CCRT Plus VIDL
	Affected / at Risk (%)	# Events
Total	0/31 (0%)
Other (Not Including Serious) Adverse Events
	CCRT Plus VIDL
	Affected / at Risk (%)	# Events
Total	30/30 (100%)
Blood and lymphatic system disorders
Neutropenia	30/30 (100%)	30

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.