S-1 Combined With IMRT Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma

NCT03668366 | Completed Phase 2 DMC

• 1 other identifier: NPC-S1-02
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective phase II trial which is designed to evaluate the efficacy and safety of IMRT combined with S-1 CCRT for locally advanced NPC. Eligibility criteria include histologically confirmed locally advanced NPC according to the American Joint Committee on Cancer (AJCC) Staging System (the eighth edition); Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; at least one measurable lesion based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1; normal complete blood count, normal hepatic function and normal renal function. Prior induction chemotherapy with platinum was allowed. Exclusion criteria include previous radiotherapy, a history of any other type of malignancy; pregnancy or lactation; allergy to S-1; obvious dysfunction of liver, renal, cardiac or lung function; uncontrolled infection; systemic metastasis or distant metastasis; patients with severe gastrointestinal diseases, and patients with mental disorders affecting patient participation in trial judgement. The full-set pretreatment evaluation will be performed to every patient.All patients in this study will receive intensity-modulated radiation therapy (IMRT). During the IMRT course, S-1 will be administered orally according to body surface area.The dose modifications of S-1 will not be permitted during concurrent chemotherapy unless progression of the disease, toxicities of grade 4 or patient's refusal. The primary endpoints of this study is adverse events (AE) rate and progression-free survival (PFS).

Conditions

Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinoma; IMRT; S-1

Outcome Measures

Primary Outcomes (1)

• PFS

  PFS is calculated from the date of the enrollment to the date of disease progression or the date of death for any cause.

  3-year PFS （2018-2021）

Study Arms (1)

S-1 arm

EXPERIMENTAL

The patients in the S-1 arm will receive IMRT (66-70.4Gy to GTV, 57-60.8Gy to CTV1, 54-56Gy to CTV2, given in 30-32 fractions). During the IMRT course, S-1 will be administered orally according to body surface area (BSA\<1.25m2, 30mg; BSA: 1.25-1.5m2, 40mg; BSA\>1.5m2, 50mg) twice per day for 30-32 days. The dose modifications of S-1 will not be permitted during concurrent chemotherapy unless progression of the disease, toxicities of grade 4 or patient's refusal.

Drug: S-1

Interventions

S-1 DRUG

The patients will receive IMRT combined with S-1 concurrent chemoradiotherapy. The specific treatment description is included in arm description.

S-1 arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed locally advanced NPC
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Normal complete blood count
• Normal hepatic function
• Normal renal function (creatinine ≤ 1.5 times the upper limit of normal).

You may not qualify if:

• Previous radiotherapy
• A history of any other type of malignancy
• Pregnancy or lactation
• Allergy to S-1
• Obvious disfunction of liver, renal, cardiac or lung function
• Uncontrolled infection
• Systemic metastasis or distant metastasis
• Patients with severe gastrointestinal diseases
• Patients with mental disorders affecting patient participation in trial judgement.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

S 1 (combination)

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Xiaoshen Wang, MD,Ph.D

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 12, 2018
• Study Start: August 1, 2013
• Primary Completion: December 1, 2018
• Study Completion: August 1, 2020
• Last Updated: February 11, 2021

Record last verified: 2021-02

Locations

CN (1)