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SOX as Salvage Treatment in Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status

Terminated

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

S-1 plus oxaliplatin

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal carcinoma, S-1, Oxaliplatin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age range: 18-75 years old
Histological confirmed incurable relapsed or metastatic nasopharyngeal carcinoma
Prior exposure of at least one line of platinum-containing regimen
ECOG performance status 0-1
Life expectancy of more than 3 months
Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧80g/L
Liver function: total bilirubin, ALT and AST <1.5×UNL
Renal function: Cr<1.5×UNL, CCR≧50ml/min
Without > 1 grade of neuropathy

Exclusion Criteria:

With curable treatment option
With CNS involvement
Prior platinum exposure only in neo-adjuvant/adjuvant setting or concurrently used with radiotherapy
Treated with > 2 lines of palliative chemotherapy
With prior exposure of S-1 or oxaliplatin
History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
Significant active infection
Pregnant or lactating women

Sites / Locations

Fudan University Shanghai Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

S-1 plus oxaliplatin

Arm Description

S-1 60 mg BID at day 1-14 Oxaliplatin 100 mg/m2 at day 1 Frequence of cycles: every 3 weeks for 6 cycles

Outcomes

Primary Outcome Measures

Median progression-free survival

Secondary Outcome Measures

Overall response rate

Median overall survival

Full Information

NCT ID

NCT01403259

First Posted

July 26, 2011

Last Updated

August 19, 2014

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT01403259

Brief Title

SOX as Salvage Treatment in Nasopharyngeal Carcinoma

Official Title

Phase II Study of SOX in Patients With Platinum-resistant Nasopharyngeal Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Terminated

Why Stopped

poor accrual of eligible patients

Study Start Date

July 2011 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of the study is to evaluate the efficacy and safety of SOX regimen (S-1 plus oxaliplatin) as salvage treatment in patients with relapsed or metastatic nasopharyngeal carcinoma.

Detailed Description

The treatment option in patients with platinum-resistant relapsed or metastatic nasopharyngeal carcinoma is limited. Previous studies showed that both S-1 and oxaliplatin were effective in head and neck cancer. Moreover, SOX (S-1 plus oxaliplatin) was proved to be tolerable in advanced stage gastric cancer. Therefore, we aim to evaluate this regimen in salvage setting of nasopharyngeal carcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal carcinoma, S-1, Oxaliplatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

S-1 plus oxaliplatin

Arm Type

Experimental

Arm Description

S-1 60 mg BID at day 1-14 Oxaliplatin 100 mg/m2 at day 1 Frequence of cycles: every 3 weeks for 6 cycles

Intervention Type

Drug

Intervention Name(s)

S-1 plus oxaliplatin

Other Intervention Name(s)

S-1, Oxaliplatin

Intervention Description

S-1 60 mg BID at day 1-14 Oxaliplatin 100 mg/m2 at day 1 Frequence of cycles: every 3 weeks

Primary Outcome Measure Information:

Title

Median progression-free survival

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Overall response rate

Time Frame

6 weeks

Title

Median overall survival

Time Frame

1.5 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age range: 18-75 years old Histological confirmed incurable relapsed or metastatic nasopharyngeal carcinoma Prior exposure of at least one line of platinum-containing regimen ECOG performance status 0-1 Life expectancy of more than 3 months Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧80g/L Liver function: total bilirubin, ALT and AST <1.5×UNL Renal function: Cr<1.5×UNL, CCR≧50ml/min Without > 1 grade of neuropathy Exclusion Criteria: With curable treatment option With CNS involvement Prior platinum exposure only in neo-adjuvant/adjuvant setting or concurrently used with radiotherapy Treated with > 2 lines of palliative chemotherapy With prior exposure of S-1 or oxaliplatin History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix Significant active infection Pregnant or lactating women

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ye Guo, MD

Organizational Affiliation

Fudan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

Country

China

12. IPD Sharing Statement

Learn more about this trial

SOX as Salvage Treatment in Nasopharyngeal Carcinoma

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