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Completed

NCT Number: NCT02606916

Radiotherapy Combined With S-1/DDP for Elderly Esophageal Squamous Cell Cancer.

This Prospective, single-arm Phase Ⅱ study is to determine the efficacy and safety of Once-daily Simultaneous Modulated Accelerated Radiotherapy combined with S-1/DDP for geratic esophageal squamous cell carcinoma patients.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pathologically or cytologically confirmed esophageal squamous cell carcinoma.
  • Stage II-IVa ESCC confirmed by endoscopic ultrasonography(EUS) and imaging studies.
  • Aging from 70 to 80.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Charlson's weighted index of comorbidities (WIC) ≤4;
  • White blood cell count ≥4×109 /L, neutrophile granulocyte count≥1.5×109 /L, platelet count≥100×109 /L, hemoglobin ≥100 g /L, serum creatinine and bilirubin 1.5 times less than the upper limits of normal (ULN),aminotransferase two times less than the ULN.
  • Weight loss ≤15% within the past half year.
  • Forced expiratory volume in 1 s≥ 1 L.
  • Patients and their family signed the informed consents.

Exclusion criteria

  • Previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ.
  • Already received antineoplastic therapy,including chemotherapy, radiotherapy or operation.
  • Any contraindication for chemotherapy or radiotherapy(such as a myocardial infarction within 6 months,immunosuppressive therapy,symptomatic heart disease,including unstable angina pectoris, congestive heart failure,and uncontrolled arrhythmia.)
  • Malignant pleural effusion or pericardial effusion.
  • Weight loss >10% within the past 3 months.
  • Recruited in other clinical trials within 30 days
  • Drug addiction, long-term alcohol abuse and AIDS patients.
  • Uncontrollable epileptic attack or psychotic patients without self-control ability.
  • Severe allergy or idiosyncrasy.
  • Not suitable for this study judged by researchers.

Treatment and study plan

SMART

Radiation

Once-daily simultaneous modulated accelerated radiotherapy(64Gy/30f )

DDP

Drug

DDP(25 mg/m2.qw) for six weeks.

S-1

Drug

S-1(40 mg/m2.Bid .po) on D1-14,D22-35 during radiotherapy

Primary outcomes

  1. Clinical response rate

    Time frame: 2-year

    the percentage of patients who had partial remission or complete remission after chemoradiotherapy

Secondary outcomes

  1. progression-free survival

    Time frame: 3-year

  2. overall survival

    Time frame: 3-year

  3. grade 3 or 4 toxicities according to CTCAE4.0

    Time frame: 1 year after radiochemotherapy

    the percentage of patients who develop grade 3 or 4 toxicities during and 1 year after radiochemotherapy

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

A Prospective, Single-arm Study of Simultaneous Modulated Accelerated Radiotherapy Combined With S-1/DDP for Elderly Esophageal Squamous Cell Carcinoma.

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Nov 17, 2015
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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