NCT02610010

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
462

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2015

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

November 13, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

7 years

First QC Date

November 13, 2015

Last Update Submit

November 18, 2015

Conditions

Nasopharyngeal Carcinoma

Keywords

NPCconcurrent chemotherapyIMRTstage II

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Two year

Secondary Outcomes (5)

  • failure-free survival

    two year

  • distant metastasis-free survival

    two year

  • locoregional relapse-free survival

    two year

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

    two months

  • quality of life assessing by questionnaires

    through study completion, an average of 5 year

Study Arms (2)

IMRT alone

EXPERIMENTAL

Intensity-modulated radiotherapy without cisplatin-based concurrent chemotherapy

Radiation: Intensity-modulated radiotherapy

IMRT plus concurrent chemotherapy

ACTIVE COMPARATOR

Intensity-modulated radiotherapy with cisplatin-based concurrent chemotherapy

Drug: CisplatinRadiation: Intensity-modulated radiotherapy

Interventions

CisplatinDRUG

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

Also known as: DDP
IMRT plus concurrent chemotherapy
Intensity-modulated radiotherapyRADIATION

Intensity-modulated radiotherapy

IMRT aloneIMRT plus concurrent chemotherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (6)

  • 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.

    PMID: 26528755BACKGROUND

  • 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.

    PMID: 26499947BACKGROUND

  • 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.

    PMID: 22056739BACKGROUND

  • 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.

    PMID: 20643517BACKGROUND

  • 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.

    PMID: 26318726BACKGROUND

  • 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.

    PMID: 22995588BACKGROUND

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

CisplatinRadiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsRadiotherapy, ConformalRadiotherapy, Computer-AssistedRadiotherapyTherapeutics

Study Officials

  • Fang-Yun Xie, M.D.

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fang-Yun Xie, M.D.

CONTACT

+86-020-87342618xiefy@sysucc.org.cn

Pu-Yun OuYang, M.D.

CONTACT

+86-020-87342618ouyangpy@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

November 13, 2015

First Posted

November 20, 2015

Study Start

November 1, 2015

Primary Completion

November 1, 2022

Study Completion

November 1, 2025

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations

CN(1)