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Postoperative Concurrent Chemoradiotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors

Primary Purpose

Salivary Gland Tumors, Head and Neck Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Cisplatin

Docetaxel

Intensity-modulated radiotherapy

About this trial

This is an interventional treatment trial for Salivary Gland Tumors focused on measuring Salivary Gland Tumors, Head-an-Neck cancer, Concurrent Chemoradiotherapy, High-Risk, Cisplatin, Docetaxel

Eligibility Criteria

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

Inclusion Criteria:

Pathologically proven diagnosis of a malignant salivary gland tumor of intermediate or high-grade
Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤ 5mm) or microscopically positive surgical margin
Surgical resection with curative intent within 8 weeks prior to registration, with no evidence of gross tumor residual
No evidence of distant metastases
No synchronous or concurrent head and neck primary tumors
Karnofsky score over 60
Adequate organ function including the following:
1. Absolute neutrophil count (ANC) >= 1.5 * 10^9/l
2. Platelets count >= 100 * 10^9/l
3. Hemoglobin >= 10 g/dl
4. AST and ALT <= 2.5 times institutional upper limit of normal (ULN)
5. Total bilirubin <= 1.5 times institutional ULN
6. Creatinine clearance >= 50 ml/min
7. Serum creatine <= 1 times ULN
Signed written informed consent

Exclusion Criteria:

Evidence of distant metastasis
Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

Sites / Locations

Shanghai ninth people's hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cisplatin Group

Docetaxel+Cisplatin

Arm Description

Intensity-modulated radiotherapy+concurrent chemotherapy with cisplatin for squamous carcinoma of salivary gland

Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and cisplatin for adenogenous types carcinoma of salivary gland

Outcomes

Primary Outcome Measures

Disease-free survival

from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years

Secondary Outcome Measures

Overall survival rate

from date of enrollment until date of first death from any cause, assessed up to 2 years

Acute toxicity profiles, graded according to the NCI CTCAE version 3.0

Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v3.0 during the course of treatment

Late toxicity profiles, graded according to the NCI CTCAE version 3.0

Number of participants with treatment-related late toxicity as assessed every 3 months by CTCAE v3.0 up to 2 years

Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) during the concurrent treatment

QoL score will be documented on each weekend during the course of radiotherapy

Full Information

NCT ID

NCT02776163

First Posted

May 12, 2016

Last Updated

September 24, 2018

Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

1. Study Identification

Unique Protocol Identification Number

NCT02776163

Brief Title

Postoperative Concurrent Chemoradiotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors

Official Title

Postoperative Concurrent Chemoradiotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors of Head and Neck, A Non-Randomized, Phase II Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2016 (Actual)

Primary Completion Date

May 2019 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a non-randomized, phase II, open label study of postoperative current chemoradiotherapy for high-risk malignant salivary gland tumors of head and neck.The primary purpose of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy in these patients.

6. Conditions and Keywords

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

Salivary Gland Tumors, Head and Neck Cancer

Keywords

Salivary Gland Tumors, Head-an-Neck cancer, Concurrent Chemoradiotherapy, High-Risk, Cisplatin, Docetaxel

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cisplatin Group

Arm Type

Experimental

Arm Description

Intensity-modulated radiotherapy+concurrent chemotherapy with cisplatin for squamous carcinoma of salivary gland

Arm Title

Docetaxel+Cisplatin

Arm Type

Experimental

Arm Description

Intensity-modulated radiotherapy+concurrent chemotherapy with docetaxel and cisplatin for adenogenous types carcinoma of salivary gland

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

Platinol

Intervention Description

Cisplatin 80mg/m^2，D1-3，2 cycles

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Taxotere

Intervention Description

Docetaxel 70mg/m^2，D1，2 cycles

Intervention Type

Radiation

Intervention Name(s)

Intensity-modulated radiotherapy

Intervention Description

a total dose of 60-66Gy in 30-32 fractions over 6-7 weeks

Primary Outcome Measure Information:

Title

Disease-free survival

Description

from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Overall survival rate

Description

from date of enrollment until date of first death from any cause, assessed up to 2 years

Time Frame

2 years

Title

Acute toxicity profiles, graded according to the NCI CTCAE version 3.0

Description

Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v3.0 during the course of treatment

Time Frame

up to 6 weeks

Title

Late toxicity profiles, graded according to the NCI CTCAE version 3.0

Description

Number of participants with treatment-related late toxicity as assessed every 3 months by CTCAE v3.0 up to 2 years

Time Frame

up to 2 years

Title

Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Core 35 (EORTC QLQ-HN35) during the concurrent treatment

Description

QoL score will be documented on each weekend during the course of radiotherapy

Time Frame

participants will be followed for the duration of hospital stay, an expected average of 6 weeks

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: Pathologically proven diagnosis of a malignant salivary gland tumor of intermediate or high-grade Pathologic stage T3-4 or N1-3 or T1-2, N0 with a close (≤ 5mm) or microscopically positive surgical margin Surgical resection with curative intent within 8 weeks prior to registration, with no evidence of gross tumor residual No evidence of distant metastases No synchronous or concurrent head and neck primary tumors Karnofsky score over 60 Adequate organ function including the following: Absolute neutrophil count (ANC) >= 1.5 * 10^9/l Platelets count >= 100 * 10^9/l Hemoglobin >= 10 g/dl AST and ALT <= 2.5 times institutional upper limit of normal (ULN) Total bilirubin <= 1.5 times institutional ULN Creatinine clearance >= 50 ml/min Serum creatine <= 1 times ULN Signed written informed consent Exclusion Criteria: Evidence of distant metastasis Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Guopei Zhu, M.D.

antica@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Guopei Zhu, M.D.

Organizational Affiliation

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shanghai ninth people's hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200011

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guopei Zhu, M.D.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Postoperative Concurrent Chemoradiotherapy in Treating Patients With High-Risk Malignant Salivary Gland Tumors

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