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Intensity-modulated Radiotherapy With or Without Concurrent Chemotherapy for Stage II Nasopharyngeal Carcinoma

Primary Purpose

Nasopharyngeal Carcinoma

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Cisplatin

Intensity-modulated radiotherapy

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring NPC, concurrent chemotherapy, IMRT, stage II

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Newly histologically confirmed non-keratinizing (WHO 1991) nasopharyngeal carcinoma.
Tumor staged as T1N1M0 or T2N0-1M0 (the 2010 UICC/AJCC staging system).
Karnofsky scale (KPS) ≥ 70.
Adequate marrow: leucocyte count ≥ 4×10E9/L, hemoglobin ≥ 110g/L and platelet count ≥ 100×10E9/L.
Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and bilirubin ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN.
Adequate renal function: creatinine clearance ≥ 60 ml/min or creatinine ≤ 1.5×ULN.
Patients must give written informed consent.

Exclusion Criteria:

Prior malignancy, except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
History of previous radiotherapy (except for non-melanomatous skin cancers outside intended radiotherapy volume).
Prior radiotherapy, chemotherapy or surgery (except diagnostic) to primary tumor or nodes.
Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×ULN), and emotional disturbance.

Sites / Locations

Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IMRT alone

IMRT plus concurrent chemotherapy

Arm Description

Intensity-modulated radiotherapy without cisplatin-based concurrent chemotherapy

Intensity-modulated radiotherapy with cisplatin-based concurrent chemotherapy

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

failure-free survival

distant metastasis-free survival

locoregional relapse-free survival

Number of participants with treatment-related acute adverse events as assessed by CTCAE v4.0

quality of life assessing by questionnaires

Full Information

NCT ID

NCT02610010

First Posted

November 13, 2015

Last Updated

November 18, 2015

Sponsor

Sun Yat-sen University

Collaborators

Affiliated Cancer Hospital & Institute of Guangzhou Medical University, The First Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Guangdong Pharmaceutical University

1. Study Identification

Unique Protocol Identification Number

NCT02610010

Brief Title

Intensity-modulated Radiotherapy With or Without Concurrent Chemotherapy for Stage II Nasopharyngeal Carcinoma

Official Title

Intensity-modulated Radiotherapy With or Without Concurrent Chemotherapy for Stage II Nasopharyngeal Carcinoma: a Phase 3 Non-inferior Multicenter Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Recruiting

Study Start Date

November 2015 (undefined)

Primary Completion Date

November 2022 (Anticipated)

Study Completion Date

November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

Collaborators

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

A prior phase III randomized trial showed considerable survival benefit from the combined treatment of cisplatin-based concurrent chemotherapy and two-dimensional conventional radiotherapy (2DCRT) for patients with stage II (the Chinese 1992 staging system) nasopharyngeal carcinoma. However, since intensity-modulated radiotherapy (IMRT) was known to be superior to 2DCRT in local control, progression free survival and even overall survival, it is a pivotal question whether stage II [T1N1M0 and T2N0-1M0, based on the 2010 International Union against Cancer/American Joint Committee on Cancer (UICC/AJCC) staging system] patients can still obtain significant benefit from the additional concurrent chemotherapy in the IMRT era. The investigators' retrospective study (PMID:26528755 ) indicated that low risk nasopharyngeal carcinoma (T1N1M0, T2N0-1M0 or T3N0M0, the 2010 UICC/AJCC staging system) patients who underwent IMRT could not benefit from cisplatin-based concurrent chemotherapy. Therefore, the investigators perform this randomized controlled trial to address this question, on a prudent assumption that IMRT alone was not inferior to IMRT plus concurrent chemotherapy in stage II patients.

Detailed Description

Eligible patients are randomly assigned to receive intensity-modulated radiotherapy (IMRT) alone or IMRT plus concurrent chemotherapy. IMRT is given as 2.0-2.30 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor. Concurrent chemotherapy consisted of cisplatin 100 mg/m² every 3 weeks for 3 cycles. The primary endpoint is overall survival (OS). Secondary end points include failure-free survival(FFS), locoregional relapse-free survival (LRFS), distant metastasis-free survival (DMFS), toxic effects and quality of life. All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.

6. Conditions and Keywords

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

Nasopharyngeal Carcinoma

Keywords

NPC, concurrent chemotherapy, IMRT, stage II

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

462 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IMRT alone

Arm Type

Experimental

Arm Description

Intensity-modulated radiotherapy without cisplatin-based concurrent chemotherapy

Arm Title

IMRT plus concurrent chemotherapy

Arm Type

Active Comparator

Arm Description

Intensity-modulated radiotherapy with cisplatin-based concurrent chemotherapy

Intervention Type

Drug

Intervention Name(s)

Cisplatin

Other Intervention Name(s)

DDP

Intervention Description

Cisplatin 100 mg/m² every 3 weeks for 3 cycles during radiotherapy.

Intervention Type

Radiation

Intervention Name(s)

Intensity-modulated radiotherapy

Intervention Description

Intensity-modulated radiotherapy

Primary Outcome Measure Information:

Title

Overall survival

Time Frame

Two year

Secondary Outcome Measure Information:

Title

failure-free survival

Time Frame

two year

Title

distant metastasis-free survival

Time Frame

two year

Title

locoregional relapse-free survival

Time Frame

two year

Title

Number of participants with treatment-related acute adverse events as assessed by CTCAE v4.0

Time Frame

two months

Title

quality of life assessing by questionnaires

Time Frame

through study completion, an average of 5 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Newly histologically confirmed non-keratinizing (WHO 1991) nasopharyngeal carcinoma. Tumor staged as T1N1M0 or T2N0-1M0 (the 2010 UICC/AJCC staging system). Karnofsky scale (KPS) ≥ 70. Adequate marrow: leucocyte count ≥ 4×10E9/L, hemoglobin ≥ 110g/L and platelet count ≥ 100×10E9/L. Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and bilirubin ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN. Adequate renal function: creatinine clearance ≥ 60 ml/min or creatinine ≤ 1.5×ULN. Patients must give written informed consent. Exclusion Criteria: Prior malignancy, except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period). History of previous radiotherapy (except for non-melanomatous skin cancers outside intended radiotherapy volume). Prior radiotherapy, chemotherapy or surgery (except diagnostic) to primary tumor or nodes. Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose > 1.5×ULN), and emotional disturbance.

Central Contact Person:

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

Fang-Yun Xie, M.D.

Phone

+86-020-87342618

xiefy@sysucc.org.cn

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

Pu-Yun OuYang, M.D.

Phone

+86-020-87342618

ouyangpy@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fang-Yun Xie, M.D.

Organizational Affiliation

Sun Yat-sen University Cancer Center,Guangzhou, Guangdong, China

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fang-Yun Xie, M.D.

Phone

+86-020-87342618

xiefy@sysucc.org.cn

First Name & Middle Initial & Last Name & Degree

Pu-Yun OuYang, M.D.

Phone

+86-020-87342618

ouyangpy@sysucc.org.cn

12. IPD Sharing Statement

Citations:

PubMed Identifier

26528755

Citation

Zhang LN, Gao YH, Lan XW, Tang J, Su Z, Ma J, Deng W, OuYang PY, Xie FY. Propensity score matching analysis of cisplatin-based concurrent chemotherapy in low risk nasopharyngeal carcinoma in the intensity-modulated radiotherapy era. Oncotarget. 2015 Dec 22;6(41):44019-29. doi: 10.18632/oncotarget.5806.

Results Reference

background

PubMed Identifier

26499947

Citation

Su Z, Mao YP, Tang J, Lan XW, OuYang PY, Xie FY. Long-term outcomes of concurrent chemoradiotherapy versus radiotherapy alone in stage II nasopharyngeal carcinoma treated with IMRT: a retrospective study. Tumour Biol. 2016 Apr;37(4):4429-38. doi: 10.1007/s13277-015-4266-5. Epub 2015 Oct 25.

Results Reference

background

PubMed Identifier

22056739

Citation

Chen QY, Wen YF, Guo L, Liu H, Huang PY, Mo HY, Li NW, Xiang YQ, Luo DH, Qiu F, Sun R, Deng MQ, Chen MY, Hua YJ, Guo X, Cao KJ, Hong MH, Qian CN, Mai HQ. Concurrent chemoradiotherapy vs radiotherapy alone in stage II nasopharyngeal carcinoma: phase III randomized trial. J Natl Cancer Inst. 2011 Dec 7;103(23):1761-70. doi: 10.1093/jnci/djr432. Epub 2011 Nov 4.

Results Reference

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PubMed Identifier

20643517

Citation

Lai SZ, Li WF, Chen L, Luo W, Chen YY, Liu LZ, Sun Y, Lin AH, Liu MZ, Ma J. How does intensity-modulated radiotherapy versus conventional two-dimensional radiotherapy influence the treatment results in nasopharyngeal carcinoma patients? Int J Radiat Oncol Biol Phys. 2011 Jul 1;80(3):661-8. doi: 10.1016/j.ijrobp.2010.03.024. Epub 2010 Jul 17.

Results Reference

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PubMed Identifier

26318726

Citation

Zhang MX, Li J, Shen GP, Zou X, Xu JJ, Jiang R, You R, Hua YJ, Sun Y, Ma J, Hong MH, Chen MY. Intensity-modulated radiotherapy prolongs the survival of patients with nasopharyngeal carcinoma compared with conventional two-dimensional radiotherapy: A 10-year experience with a large cohort and long follow-up. Eur J Cancer. 2015 Nov;51(17):2587-95. doi: 10.1016/j.ejca.2015.08.006. Epub 2015 Aug 26.

Results Reference

background

PubMed Identifier

22995588

Citation

Peng G, Wang T, Yang KY, Zhang S, Zhang T, Li Q, Han J, Wu G. A prospective, randomized study comparing outcomes and toxicities of intensity-modulated radiotherapy vs. conventional two-dimensional radiotherapy for the treatment of nasopharyngeal carcinoma. Radiother Oncol. 2012 Sep;104(3):286-93. doi: 10.1016/j.radonc.2012.08.013. Epub 2012 Sep 17.

Results Reference

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Intensity-modulated Radiotherapy With or Without Concurrent Chemotherapy for Stage II Nasopharyngeal Carcinoma

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