Know Cancer

or
forgot password

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


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Extranodal NK/T-cell Lymphoma, Nasal Type

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

3-year Progression-free survival

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Ye Guo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: Ethics Committee

Study ID:

LMTG 12-02

NCT ID:

NCT01667302

Start Date:

June 2012

Completion Date:

December 2016

Related Keywords:

  • Extranodal NK/T-cell Lymphoma, Nasal Type
  • NK/T-cell lymphoma
  • Radiotherapy
  • Adjuvant chemotherapy
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, Extranodal NK-T-Cell

Name

Location