## Protocol Section
### Identification Module
**NCT ID:** NCT02520479

**Brief Title:** "Sandwich" Chemotherapy With Radiotherapy in Newly Diagnosed, Stage IE to IIE, ENKTL

**Official Title:** Phase 2 Trial of "Sandwich" Pegaspargase-CHOP Chemotherapy With Radiotherapy in Newly Diagnosed, Stage IE to IIE, Nasal Type, Extranodal Natural Killer/T-cell Lymphoma

#### Organization Study ID Info
**ID:** NK-SYSUCC
#### Organization
**Class:** OTHER
**Full Name:** Sun Yat-sen University
### Status Module
#### Completion Date
**Date:** 2018-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-05-09

**Type:** ACTUAL

**Last Update Submit Date:** 2018-05-08

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2017-12

**Type:** ACTUAL

#### Start Date
**Date:** 2013-06

**Status Verified Date:** 2016-10

#### Study First Post Date
**Date:** 2015-08-11
**Type:** ESTIMATED
**Study First Submit Date:** 2015-08-04
**Study First Submit QC Date:** 2015-08-07
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Sun Yat-sen University

#### Responsible Party

**Investigator Affiliation:** Sun Yat-sen University

**Investigator Full Name:** wanghua

**Investigator Title:** professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** A phase 2 study was conducted of "sandwich" protocols, with earlier RT after an initial 2 of P-CHOP (Pegaspargase, cyclophosphamide,vincristine, doxorubicin and dexamethasone ), followed by further two "consolidation" cycles,to explore the appropriate mode of combined modality therapy (CMT) in early stage ENKTL.

**Detailed Description:** The extranodal natural killer/T-cell lymphoma (ENKTL) shows high local or systemic failure rates when radiotherapy (RT) is taken as the primary treatment, suggesting a role for chemotherapy (CT) added to RT for this disease. However, the appropriate mode of combined modality therapy (CMT) has not been fully defined.We conducted a prospective phase II study of "Sandwich" Pegaspargase, cyclophosphamide,vincristine, doxorubicin and dexamethasone (P-CHOP) regimen in combination with radiotherapy.The "sandwich" protocols, refer to earlier RT after an initial 2 cycles of P-CHOP followed by further two "consolidation" cycles.

### Conditions Module

**Conditions:**

- Treatment Refusal

**Keywords:**

- extranodal natural killer/T-cell lymphoma

- nasal type

- radiotherapy

- chemotherapy

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 12

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** sandwich protocols: Patients with newly diagnosed ENKTL is given 2 cycles of P-CHOP\[cyclophosphamide(CTX), 750 mg/m2 day 1; vincristine(VCR), 1.4 mg/m2 day 1 (maximal dose 2 mg),adriamycin(ADM) 50 mg/m2 day 1; dexamethasone(DXM) 10 mg days 1-8; Pegaspargase 2500 international unit day 1\] before radiotherapy(RT) and then two "consolidation" cycles after RT.

**Intervention Names:**

- Drug: P-CHOP

- Radiation: Radiotherapy

**Label:** sandwich protocols

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- sandwich protocols

**Description:** Two cycles of P-CHOP:cyclophosphamide, 750 mg/m2 day 1; vincristine,(maximal dose 2 mg),adriamycin , 50 mg/m2 day 1; dexamethasone,10mg days 1-8; Pegaspargase, 2500IU/m2 day 1 are given before radiotherapy

**Name:** P-CHOP

**Other Names:**

- CTX, VCR, ADM , DXM, Pegaspargase

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- sandwich protocols

**Description:** Radiotherapy was scheduled after 2 cycles of P-CHOPregimen. Involved field radiotherapy(IFRT) is delivered using 6-Million electron Volts linear accelerator using 3-dimensional conformable treatment planning. The IFRT dose was 56 grays (Gy) in 28 fractions.

**Name:** Radiotherapy

**Other Names:**

- radiotherapy after induction chemotherapy

**Type:** RADIATION

#### Intervention 3

**Arm Group Labels:**

- sandwich protocols

**Description:** Two "consolidation" cycles of P-CHOP are given after radiotherapy

**Name:** P-CHOP

**Other Names:**

- CTX, VCR, ADM , DXM, Pegaspargase

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The criteria for the efficacy evaluation (complete remission) of the regimen is according to the following article.

Cheson BD, Horning SJ, Coiffier B, et al. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. J Clin Oncol. 1999;17:1244

**Measure:** complete remission rate

**Time Frame:** every 4 weeks,up to completion of treatment(approximately 6 months)

#### Secondary Outcomes

**Description:** time from the date of enrollment to date of disease progression, or death of any cause, or date of lost follow-up, whichever comes first

**Measure:** progression free survival

**Time Frame:** up to end of follow-up-phase (approximately 3 years)

**Description:** time from the date of enrollment to date of death from any cause, or date of lost follow-up, whichever comes first.

**Measure:** overall survival

**Time Frame:** up to end of follow-up-phase (approximately 3 years)

**Description:** including hematological safety and non-hematological safety. All the adverse events will be classified according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

**Measure:** Hematological and non-hematological safety as a measure of adverse events according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE)

**Time Frame:** up to end of follow-up-phase (approximately 3 years)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* newly diagnosed ENKTL
* age:18-69years
* Ann Arbor stage IE,or stage IIE with cervical lymph node involvement
* at lease one measurable lesion
* receive no chemotherapy or radiotherapy before
* Eastern CooperativeOncology Group performance status of 0 to 2.
* Adequate hematologic function (eg, white blood cell ≥ 3×10e9/l,neutrophils count ≥1.5×10e9/L, and platelet count≥ 100×10e9/L),renal function (eg, serum creatinine≤1.5 mg/dL and creatinine clearance ≥50 mL minute), and hepatic function (e.g, total bilirubin≤ 2 times the upper limit of normal and aspartate and alanine transaminase levels ≤ 3 times the upper limit of normal)

Exclusion Criteria:

* mismatch the inclusion criteria
* systematic central nervous system involvement
* previous or concomitant malignancies and any coexisting medical problems that could cause poor compliance with the study protocol.
* primary lesion not from the upper respiratory

**Maximum Age:** 69 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Guangzhou

**Country:** China

**Facility:** Sun Yat-sen University Cancer Center

**State:** Guangdong

**Zip:** 510060

#### Overall Officials

**Official 1:**

**Affiliation:** Clinical Research Center

**Name:** minghuang hong, MD.

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11220

- Name: Lymphoma

- Relevance: LOW

- As Found: Unknown

- ID: M18829

- Name: Lymphoma, T-Cell

- Relevance: LOW

- As Found: Unknown

- ID: M18833

- Name: Lymphoma, T-Cell, Peripheral

- Relevance: LOW

- As Found: Unknown

- ID: T3543

- Name: Lymphosarcoma

- Relevance: LOW

- As Found: Unknown

- ID: T4496

- Name: Peripheral T-cell Lymphoma

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: ARhu

- Name: Antirheumatic Agents

### Intervention Browse Module - Browse Leaves

- ID: M7102

- Name: Dexamethasone

- Relevance: LOW

- As Found: Unknown

- ID: M6727

- Name: Cyclophosphamide

- Relevance: LOW

- As Found: Unknown

- ID: M17495

- Name: Vincristine

- Relevance: LOW

- As Found: Unknown

- ID: M235549

- Name: Dexamethasone acetate

- Relevance: LOW

- As Found: Unknown

- ID: M251156

- Name: Pegaspargase

- Relevance: HIGH

- As Found: Induction therapy

- ID: M4522

- Name: Asparaginase

- Relevance: HIGH

- As Found: Induction therapy

### Intervention Browse Module - Meshes

- ID: C000042705

- Term: Pegaspargase

- ID: D000001215

- Term: Asparaginase

### Misc Info Module

- Version Holder: 2024-05-24
