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Therapeutic Gain by Induction-concurrent Chemoradiotherapy and/or Accelerated Fractionation for Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Capecitabine

Adjuvant chemotherapy using PF (5-Fluorouracil )

Induction chemotherapy using PF (5-Fluorouracil)

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal Carcinoma, Chemoradiotherapy, Accelerated Fractionation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

histologically proven nasopharyngeal carcinoma for primary treatment with radical intent
non-keratinizing or undifferentiated type
stage III-IVB (by AJCC/UICC 6th edition)
ECOG Performance status less or equal to 2
Marrow: WBC >= 4 and platelet >=100
Renal: creatinine clearance >=60
Informed consent

Exclusion Criteria:

Primary treatment with palliative intent
WHO type I squamous cell carcinoma or adenocarcinoma
Evidence of distant metastases
Patient is pregnant or lactating
Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer or other cancer for which the patient has been disease-free for 5 years

Sites / Locations

Cancer Center, Sun Yat Sen University
Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital
Department of Clinical Oncology, Prince of Wales Hospital
Department of Clinical Oncology, Princess Margaret Hospital
Department of Clinical Oncology, Queen Elizabeth Hospital
Department of Clinical Oncology, Queen Mary Hospital
Department of Clinical Oncology, Tuen Mun Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

Arm Description

Concurrent-Adjuvant CRT using P-PF regimen and conventional fractionation radiotherapy

Concurrent-Adjuvant CRT using P-PF regimen and accelerated fractionation radiotherapy

Induction-Concurrent CRT using PF-P regimen and conventional fractionation radiotherapy

Induction-Concurrent CRT using PF-P regimen and accelerated fractionation radiotherapy

Induction-Concurrent CRT using PX-P regimen and conventional fractionation radiotherapy

Induction-Concurrent CRT using PX-P regimen and accelerated fractionation radiotherapy

Outcomes

Primary Outcome Measures

Progression-Free Survival, defined as the time to treatment failure at any site or death due to any cause, at 5-year.

Overall Survival, defined as the time to death due to any cause, at 5-year.

Secondary Outcome Measures

overall Failure-Free Rate, defined as time to failure at any site)

Loco-regional Failure-Free Rate, defined as time to local or nodal failure)

Distant Failure-Free Rate, defined as time to distant failure)

Incidence of chemotherapy toxicity and acute RT toxicity grade > 3

Time to late toxicity (From the date of randomization to the earliest date of late toxicity grade > 3)

Full Information

NCT ID

NCT00379262

First Posted

September 20, 2006

Last Updated

August 5, 2019

Sponsor

Hong Kong Nasopharyngeal Cancer Study Group Limited

Collaborators

The Hong Kong Anti-Cancer Society, hong Kong Cancer Fund

1. Study Identification

Unique Protocol Identification Number

NCT00379262

Brief Title

Therapeutic Gain by Induction-concurrent Chemoradiotherapy and/or Accelerated Fractionation for Nasopharyngeal Carcinoma

Official Title

Randomized Trial to Evaluate Therapeutic Gain by Changing Chemoradiotherapy From Concurrent-adjuvant to Induction-concurrent Sequence, and Radiotherapy From Conventional to Accelerated Fractionation for Advanced Nasopharyngeal Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

September 2006 (undefined)

Primary Completion Date

May 2017 (Actual)

Study Completion Date

December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hong Kong Nasopharyngeal Cancer Study Group Limited

Collaborators

The Hong Kong Anti-Cancer Society, hong Kong Cancer Fund

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The objectives of this clinical study are threefold: To compare the benefits in cancer control and survival obtained from adding induction-concurrent chemotherapy to radiation with those from adding concurrent-adjuvant chemotherapy to radiation. To test whether replacing fluorouracil with Xeloda in combining with cisplatin in the chemotherapy plan will maintain or improve further the chemotherapy benefits while reducing the duration of hospital stay. To see if accelerated fractionation radiotherapy can improve the outcome of patients as compared with conventional fractionation radiotherapy.

Detailed Description

primary objectives include comparing induction chemotherapy with Cisplatin + 5-Fluorouracil versus adjuvant chemotherapy with Cisplatin + 5-Fluorouracil(PF-Pvs P-PF) comparing induction chemotherapy with Cisplatin + Capecitabine versus adjuvant chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs P-PF) comparing accelerated fractionation versus conventional fractionation (AF vs CF)radiotherapy. secondary objectives include comparing induction chemotherapy with Cisplatin + Capecitabine versus induction chemotherapy with Cisplatin + 5-Fluorouracil(PX-P vs PX-P) Comparing concurrent-adjuvant (CA) versus induction-concurrent (IC) chemotherapy sequence.

6. Conditions and Keywords

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

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinoma, Chemoradiotherapy, Accelerated Fractionation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

803 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Concurrent-Adjuvant CRT using P-PF regimen and conventional fractionation radiotherapy

Arm Title

Arm Type

Experimental

Arm Description

Concurrent-Adjuvant CRT using P-PF regimen and accelerated fractionation radiotherapy

Arm Title

Arm Type

Experimental

Arm Description

Induction-Concurrent CRT using PF-P regimen and conventional fractionation radiotherapy

Arm Title

Arm Type

Experimental

Arm Description

Induction-Concurrent CRT using PF-P regimen and accelerated fractionation radiotherapy

Arm Title

Arm Type

Experimental

Arm Description

Induction-Concurrent CRT using PX-P regimen and conventional fractionation radiotherapy

Arm Title

Arm Type

Experimental

Arm Description

Induction-Concurrent CRT using PX-P regimen and accelerated fractionation radiotherapy

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Other Intervention Name(s)

Xeloda

Intervention Description

Dose:1000 mg/m2, BD, Day 1-Day 14 Interval: 21 days Cycles: 3 cycles

Intervention Type

Drug

Intervention Name(s)

Adjuvant chemotherapy using PF (5-Fluorouracil )

Intervention Description

Cisplatin 80 mg/m2 IV + 5-Fluorouracil 1000 mg/m2/day IV infusion for 96 hr every 28 days for 3 cycles

Intervention Type

Drug

Intervention Name(s)

Induction chemotherapy using PF (5-Fluorouracil)

Intervention Description

Cisplatin 100 mg/m2 IV + 5-Fluorouracil 1000 mg/m2/day IV infusion for 120 hr every 21 days for 3 cycles

Primary Outcome Measure Information:

Title

Progression-Free Survival, defined as the time to treatment failure at any site or death due to any cause, at 5-year.

Time Frame

5 years

Title

Overall Survival, defined as the time to death due to any cause, at 5-year.

Time Frame

5 years

Secondary Outcome Measure Information:

Title

overall Failure-Free Rate, defined as time to failure at any site)

Time Frame

5 years

Title

Loco-regional Failure-Free Rate, defined as time to local or nodal failure)

Time Frame

5 years

Title

Distant Failure-Free Rate, defined as time to distant failure)

Time Frame

5 years

Title

Incidence of chemotherapy toxicity and acute RT toxicity grade > 3

Time Frame

treatment

Title

Time to late toxicity (From the date of randomization to the earliest date of late toxicity grade > 3)

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: histologically proven nasopharyngeal carcinoma for primary treatment with radical intent non-keratinizing or undifferentiated type stage III-IVB (by AJCC/UICC 6th edition) ECOG Performance status less or equal to 2 Marrow: WBC >= 4 and platelet >=100 Renal: creatinine clearance >=60 Informed consent Exclusion Criteria: Primary treatment with palliative intent WHO type I squamous cell carcinoma or adenocarcinoma Evidence of distant metastases Patient is pregnant or lactating Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer or other cancer for which the patient has been disease-free for 5 years

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anne W.M. Lee, F.R.C.R.

Organizational Affiliation

Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital, Hong Kong

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Roger K.C. Ngan, F.R.C.R

Organizational Affiliation

Department of Clinical Oncology, Quen Elizabeth Hospital, Hong Kong

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer Center, Sun Yat Sen University

City

Guangzhou

Country

China

Facility Name

Department of Clinical Oncology, Pamela Youde Nethersole Eastern Hospital

City

Hong Kong

Country

China

Facility Name

Department of Clinical Oncology, Prince of Wales Hospital

City

Hong Kong

Country

China

Facility Name

Department of Clinical Oncology, Princess Margaret Hospital

City

Hong Kong

Country

China

Facility Name

Department of Clinical Oncology, Queen Elizabeth Hospital

City

Hong Kong

Country

China

Facility Name

Department of Clinical Oncology, Queen Mary Hospital

City

Hong Kong

Country

China

Facility Name

Department of Clinical Oncology, Tuen Mun Hospital

City

Hong Kong

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

9552031

Citation

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PubMed Identifier

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Citation

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Results Reference

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PubMed Identifier

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Citation

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Citation

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Citation

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Therapeutic Gain by Induction-concurrent Chemoradiotherapy and/or Accelerated Fractionation for Nasopharyngeal Carcinoma

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