Radiotherapy Followed by Adjuvant Chemotherapy in NK/T-cell Lymphoma

Extranodal NK/T-cell Lymphoma, Nasal Type Clinical Trial

Official title:

A Phase II Study of Radiotherapy Followed by Chemotherapy With DICEP Regimen in Patients With NK/T-cell Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01667302
• Other study ID #: LMTG 12-02
• Status: Recruiting
• Phase: Phase 2
• First received: August 13, 2012
• Last updated: March 2, 2013
• Start date: June 2012
• Est. completion date: December 2016

Study information

• Verified date: March 2013
• Source: Fudan University
• Contact: Ye Guo, MD
• Phone: 862164175590
• Email: pattrick_guo[@]msn.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and tolerability of radiotherapy followed by adjuvant chemotherapy in stage I/II NK/T-cell lymphoma.

Description:

For patients with stage I/II NK/T-cell lymphoma, the sequence of radiotherapy and chemotherapy is controversial. Some studies demonstrated the advantage of upfront radiotherapy. Therefore, we designed this single-arm phase II study to evaluate the efficacy and safety of radiotherapy followed by adjuvant chemotherapy with DICE regimen plus peg-asparaginase which was proved to be effective in NK/T-cell lymphoma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2016
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age range 14-70 years old

• Histological confirmed, previously untreated stage I/II NK/T cell lymphoma in the upper-aerodigestive tract

• ECOG performance status 0-1

• Life expectancy of more than 3 months

• Without prior history of pancreatitis

• Adequate bone marrow and organ functions

Exclusion Criteria:

• Low risk population (Definition: stage I without local invasion, B symptoms and high LDH level)

• Pregnant or lactating women

• With contraindication of steroid including uncontrolled diabetes

• Serious uncontrolled diseases and intercurrent infection

• History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Extranodal NK/T-cell Lymphoma, Nasal Type
• Lymphoma
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, T-Cell

Intervention

Drug:
• Radiotherapy followed by chemotherapy
Radiotherapy Technique: IMRT Total dose: 50 Gy Per fraction: 2 Gy Chemotherapy: q3w Dexamethasone 40 mg d1-4 Ifosfamide 1200mg/m2 d1-4 Etoposide 60 mg/m2 d1-4 Cisplatin 20mg/m2 d1-4 Peg-asparaginase 2000 IU/m2 d1

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	SHanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year Progression-free survival		3 years	No
Secondary	Overall response rate		3 years	Yes
Secondary	3-year overall survival		3 years	No
Secondary	Safety		3 years	Yes