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

NCT ID: NCT02610010

Last Updated: 2015-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

462 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2025-11-30

Brief Summary

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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

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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.

Conditions

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Nasopharyngeal Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IMRT alone

Intensity-modulated radiotherapy without cisplatin-based concurrent chemotherapy

Group Type EXPERIMENTAL

Intensity-modulated radiotherapy

Intervention Type RADIATION

Intensity-modulated radiotherapy

IMRT plus concurrent chemotherapy

Intensity-modulated radiotherapy with cisplatin-based concurrent chemotherapy

Group Type ACTIVE_COMPARATOR

Cisplatin

Intervention Type DRUG

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

Intensity-modulated radiotherapy

Intervention Type RADIATION

Intensity-modulated radiotherapy

Interventions

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Cisplatin

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

Intervention Type DRUG

Intensity-modulated radiotherapy

Intensity-modulated radiotherapy

Intervention Type RADIATION

Other Intervention Names

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DDP

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Affiliated Cancer Hospital & Institute of Guangzhou Medical University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Guangdong Pharmaceutical University

OTHER

Sponsor Role collaborator

Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Fang-Yun Xie

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fang-Yun Xie, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fang-Yun Xie, M.D.

Role: CONTACT

[email protected]
+86-020-87342618

Pu-Yun OuYang, M.D.

Role: CONTACT

[email protected]
+86-020-87342618

Facility Contacts

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Fang-Yun Xie, M.D.

Role: primary

[email protected]
+86-020-87342618

Pu-Yun OuYang, M.D.

Role: backup

[email protected]
+86-020-87342618

References

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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.

Reference Type BACKGROUND
PMID: 26528755 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26499947 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22056739 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20643517 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26318726 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22995588 (View on PubMed)

Other Identifiers

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2015-FXY-066-Dept. of RT

Identifier Type: -

Identifier Source: org_study_id