GELAD Chemotherapy and Sandwiched Radiotherapy in the Treatment of Stage IE/IIE Natural Killer/T-cell Lymphoma

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT02733458

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

7.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of gemcitabine, etoposide, pegaspargase and dexamethasone (GELAD) chemotherapy and sandwiched radiotherapy as first-line treatment in patients with de novo stage IE/IIE extranodal natural killer/T-cell lymphoma, nasal type.

Condition or Disease	Intervention/Treatment	Phase
Extranodal NK-T-Cell Lymphoma, Nasal Type	Drug: GELAD Radiation: Radiotherapy	N/A

Detailed Description

Extranodal natural killer/T-cell lymphoma (ENKTCL), nasal type, is a rare subtype of non-Hodgkin lymphoma (NHL) with relatively high incidence in China. Radiotherapy alone for stage IE/IIE diseases has good response rate but with high relapse rates, ranging from 20-50%. The combination of chemotherapy and radiotherapy improved the long-term survival for patients with stage IE/IIE diseases. But the optimal treatment schedule has not been established. This study is designed with two cycles GELAD chemotherapy, followed by 50-56Gy radiotherapy, and completed with additional two cycles GELAD chemotherapy. The efficacy and safety of this sandwiched chemoradiotherapy in the treatment of stage IE/IIE ENKTCL will be measured.

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Efficacy and Safety of Gemcitabine, Etoposide, Dexamethasone and Pegaspargase Chemotherapy (GELAD) With Sandwiched Radiotherapy in the Treatment of Stage IE/II Natural Killer/T-Cell Lymphoma: A Multicenter, Prospective Study

Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Apr 1, 2021

Actual Study Completion Date :

Apr 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GELAD/Radiation Patients will be initially treated with two cycles GELAD chemotherapy, followed by 50-56Gy radiotherapy, and completed with another two cycles GELAD chemotherapy. GELAD chemotherapy will be repeated every 21 days. Radiotherapy will be delivered in 25-32 fractions.	Drug: GELAD Gemcitabine, 1.0g/m2/d IV, day 1 Etoposide, 60mg/m2 IV, day 1 to day 3 Dexamethasone, 40mg/d IV, day 1 to day 4 Pegaspargase, 2000IU/m2/d IM, day 4 Other Names: Gemcitabine, Etoposide, Dexamethasone, Pegaspargase Radiation: Radiotherapy Radiotherapy: 50-56Gy

Arm

Intervention/Treatment

Experimental: GELAD/Radiation

Patients will be initially treated with two cycles GELAD chemotherapy, followed by 50-56Gy radiotherapy, and completed with another two cycles GELAD chemotherapy. GELAD chemotherapy will be repeated every 21 days. Radiotherapy will be delivered in 25-32 fractions.

Drug: GELAD

Gemcitabine, 1.0g/m2/d IV, day 1 Etoposide, 60mg/m2 IV, day 1 to day 3 Dexamethasone, 40mg/d IV, day 1 to day 4 Pegaspargase, 2000IU/m2/d IM, day 4

Other Names:

Gemcitabine, Etoposide, Dexamethasone, Pegaspargase

Radiation: Radiotherapy

Radiotherapy: 50-56Gy

Outcome Measures

Primary Outcome Measures

Complete response rate [28 days after 4 cycles of chemotherapy]
The complete response rate will be assessed on day 28 after the 4th course of chemotherapy.

Secondary Outcome Measures

Progression free survival [2-year]
Progression free survival is the time from entry onto the treatment until lymphoma progression or death of any reason.
Overall Response rate [28 days after 4 cycles of chemotherapy]
The complete response rate will be assessed on day 28 after the 4th course of chemotherapy.
Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [Day 1 of each course and then every 3 months for 2 years]
Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v4.0.
Overall survival [2-year]
Overall survival is defiend as the time from entry onto the treatment until death of any reason

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Pathological diagnosis of extranodal natural killer/T-cell lymphoma, nasal type, previously untreated
Eastern Cooperative Oncology Group (ECOG ) performance status 0~3
Stage IE to IIE disease with at least one measurable lesion in the nasal cavity, paranasal sinuses, orbit, pharynx, Waldeyer's ring, or oral cavity.
Preserved organ functions for: absolute neutrophil counter (ANC)>1.0×109/L, Platelet>50×109/L, hemoglobin>80g/L, total bilirubin (TBIL)<2×ULN, alanine transaminase (ALT)<2×ULN, serum creatinine<1.5×ULN，fibrinogen≥1.0g/L, LVEF≥50%
No history of chemotherapy or radiotherapy.
Signed Informed consented

Exclusion Criteria:

Concurrent cancers need surgery or chemotherapy within 6 months.
Significant complications: LVEF≤50%, coagulopathy, autoimmune disease, severe infection, or liver cirrhosis, hemophagocytic lymphohistiocytosis.
Mental disorders.
Pregnant or lactation
HIV, hepatitis virus C (HCV), or active hepatitis virus B (HBV) infection with HBV DNA≥105 copies/ml.
History of pancreatitis
Known history for grade 3/4 allergy to the drugs in chemotherapy regimen.
Enrolled in other trial treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Dong Fang hospital	Shanghai	Shanghai	China	200120
2	Department of Hematology, Renji Hospital	Shanghai	Shanghai	China	201100
3	South Renji hospital	Shanghai	Shanghai	China	201100
4	Xin Jiang People's Hospital	Urumqi	Xinjiang	China	830001
5	Shanghai Ninth Peoples' Hospital	Shanghai		China	200011
6	Shanghai Eye and ENT Hospital of Fudan University	Shanghai		China	200031
7	Xinhua Hospital	Shanghai		China