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Single-agent Capecitabine as Adjuvant Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma (CAN)

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ClinicalTrials.gov Identifier: NCT02958111
Recruitment Status : Active, not recruiting
First Posted : November 8, 2016
Last Update Posted : June 12, 2019
Sponsor:
Collaborators:
Tongji Hospital
Wuhan Union Hospital, China
Peking University
Fourth Military Medical University
Second Affiliated Hospital of Soochow University
West China Hospital
The First Affiliated Hospital of Guangdong Pharmaceutical University
First People's Hospital of Foshan
Fifth Affiliated Hospital, Sun Yat-Sen University
Cancer Hospital of Guizhou Province
Xiangya Hospital of Central South University
First Affiliated Hospital of Zhejiang University
Jilin Provincial Tumor Hospital
Henan Cancer Hospital
Hunan Cancer Hospital
The First Affiliated Hospital of Xiamen University
Cancer Hospital of Guangxi Medical University
Information provided by (Responsible Party):
Jun Ma, MD, Sun Yat-sen University

Brief Summary:
This is an randomized, controlled, multicenter phase 3 clinical trial. The purpose of this study is to evaluate the efficacy and safety of single-agent capecitabine as adjuvant chemotherapy in locoregionally advanced nasopharyngeal carcinoma (NPC).

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Drug: Capecitabine Phase 3

Detailed Description:
In this study, NPC patients (stage III-IV A, except T3-4 N0 and T3 N1) who finished the curative radiotherapy will be randomized to the observation group and capecitabine group (650 mg/m2 bid, p.o.,d1-21,q3wks; continued until disease progression, unacceptable toxicity, or over 1 year). The primary endpoint is progression-free survival (PFS). Secondary end points include overall survival (OS), distant failure-free survival (D-FFS), locoregional failure-free survival (LR-FFS), toxic effects, and quality of life (QOL). All efficacy analyses are conducted in the intention-to-treat population, and the safety population include only patients who receive their randomly assigned treatment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 406 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-agent Capecitabine as Adjuvant Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma: A Phase 3, Multicentre, Randomised Controlled Trial (CAN)
Study Start Date : January 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Adjuvant capecitabine
Adjuvant chemotherapy with single-agent capecitabine
Drug: Capecitabine
Patients will receive capecitabine (650 mg/m2 bid, p.o.,d1-21,q3wks; continued until disease progression, unacceptable toxicity, or over 1 year).

No Intervention: Observation
Clinical follow-up and surveillance only



Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 3 years ]
  2. Distant failure-free survival [ Time Frame: 3 years ]
  3. Locoregional failure-free survival [ Time Frame: 3 years ]
  4. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 1 year ]
  5. Quality of life (QOL) as assessed by EORTC quality of life questionnaire(QLQ)-C30 [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-65
  2. Performance status of Eastern Cooperative Oncology Group (ECOG) grade 0 or 1
  3. Tumor staged as American Joint Committee on Cance (AJCC) III-IV A (except T3-4 N0, T3 N1), with newly histologically confirmed non-keratinizing NPC
  4. Within 12-16weeks after completion of the recommended curative radiotherapy treatment
  5. No clinical evidence of persistent loco-regional disease or distant metastases after radiotherapy
  6. Complete the recommended concurrent chemotherapy ± induction chemotherapy
  7. Adequate hematologic (neutrophil count > 1.5×10^9/L, hemoglobin > 90g/L and platelet count > 100×10^9/L), hepatic (alanine aminotransferase, aspartate aminotransferase ≤ 1.5×ULN, bilirubin ≤ 1.5×ULN, alkaline phosphatase < 2.5×ULN) and renal function (creatinine clearance > 50 ml/min)
  8. Patients must be informed of the investigational nature of this study and give written informed consent.

Exclusion Criteria:

  1. Patients who could not tolerate or allergic to capecitabine.
  2. Illness that would interfere with oral medication, including dysphagia, chronic diarrhea, or ileus
  3. Prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer.
  4. Pregnancy or lactation (consider pregnancy test in women of child-bearing age and emphasize effective contraception during the treatment period).
  5. Patients who received surgery treatment, biotherapy or immunotherapy during or before radiotherapy.
  6. Patients who are receiving or highly likely to receive other chemotherapy treatment, biotherapy or immunotherapy.
  7. History of previous radiotherapy before the curative radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume).
  8. Prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes before the curative radiotherapy
  9. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02958111


Locations
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China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Tongji Hospital
Wuhan Union Hospital, China
Peking University
Fourth Military Medical University
Second Affiliated Hospital of Soochow University
West China Hospital
The First Affiliated Hospital of Guangdong Pharmaceutical University
First People's Hospital of Foshan
Fifth Affiliated Hospital, Sun Yat-Sen University
Cancer Hospital of Guizhou Province
Xiangya Hospital of Central South University
First Affiliated Hospital of Zhejiang University
Jilin Provincial Tumor Hospital
Henan Cancer Hospital
Hunan Cancer Hospital
The First Affiliated Hospital of Xiamen University
Cancer Hospital of Guangxi Medical University

Publications:

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Responsible Party: Jun Ma, MD, Prof, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02958111     History of Changes
Other Study ID Numbers: 2016-FXY-075
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Jun Ma, MD, Sun Yat-sen University:
Nasopharyngeal Carcinoma
Adjuvant chemotherapy
Capecitabine
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal 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
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents