Elimination of Adjuvant Chemotherapy for Selected Stage I... | NCT03175939

Studies
Elimination of Adjuvant Chemotherapy for Selected Stage II and III Nasopharyngeal Carcinoma

NCT03175939

Sponsor

Sun Yat-sen University

Status

Completed

Last Update Posted

Jun 5, 2017Actual

Enrollment

263Actual

Phase

Phase 2

Conditions

Nasopharyngeal Cancer

Interventions

Radiotherapy
Cisplatin
5-FU

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 1998Actual

Primary Completion Date

Dec 31, 2008Actual

Completion Date

Dec 31, 2014Actual

First Submitted Date

May 31, 2017

First Submission Date that Met QC Criteria

Jun 2, 2017

First Posted Date

Jun 5, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2017

Last Update Posted Date

Jun 5, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study evaluates whether some patients with nasopharyngeal carcinoma but with low risk of distant metastasis can be treated with only radiotherapy and concomitant chemotherapy but without additional adjuvant chemotherapy.

Detailed Description

The standard treatment for stage II-III nasopharyngeal carcinoma is radiotherapy with concomitant chemotherapy and adjuvant chemotherapy. A subset of these patients has very low risk for distant metastasis that adjuvant chemotherapy is probably unnecessary. The investigators would like to know if same therapeutic effect and survival rate can be achieved without adjuvant chemotherapy, (i.e. less chemotherapy, same effect)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

263Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CCRT alone	Experimental	External beam radiotherapy > 66 Gy Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-5 at week 1 and 5 of radiotherapy Modified for IMRT: Cisplatin 60 mg/m2 IV D1, 5-FU 600 mg/m2 IV D1-3 at week 1, 4 and 7 of radiotherapy	Radiation: Radiotherapy Drug: Cisplatin Drug: 5-FU

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Radiotherapy	Radiation	External beam radiotherapy with curative intent, at least 66 Gy	CCRT alone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Distant-metastasis-free survival	percentage of patients who survived and has no distant metastasis	5 years

Secondary Outcomes

Measure	Description	Time Frame
overall survival	percentage of patients who survived	5 years
disease-free survival	percentage of patients who survived and had no disease recurrence

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

(1) biopsy-proven carcinoma of the nasopharynx,
(2) AJCC 1997 Stage II (T2aN0, T1-T2aN1) or III (T1-T2aN2) disease,
(3) normal renal function (Cr < 1.6 mg/dl),

Exclusion Criteria:

open-neck lymph node biopsy
previous chemotherapy or radiotherapy to the head and neck region
distant metastasis or other malignant diseases except skin cancer

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Skye Hung-Chun Cheng, M.D.	Koo Foundation Sun Yat-Sen Cancer Center	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009303	Nasopharyngeal Neoplasms

Ancestor Terms

ID	Term
D010610	Pharyngeal Neoplasms
D010039	Otorhinolaryngologic Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011878	Radiotherapy
D002945	Cisplatin
D005472	Fluorouracil

Ancestor Terms

ID	Term
D013812	Therapeutics
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds

Browse Leaves

Not provided

Browse Branches

Not provided