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

NCT02606916 | Completed Phase 2 DMC

• 1 other identifier: GYX2015-012
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Once-daily Simultaneous Modulated Accelerated Radiotherapy; S-1; DDP; elderly patients

Outcome Measures

Primary Outcomes (1)

• Clinical response rate

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

  2-year

Secondary Outcomes (3)

• progression-free survival

  3-year

• overall survival

  3-year

• grade 3 or 4 toxicities according to CTCAE4.0

  1 year after radiochemotherapy

Study Arms (1)

SMART & S-1/DDP

EXPERIMENTAL

Patients in experimental group receive daily simultaneous modulated accelerated radiotherapy combined with DDP and S-1.

Radiation: SMART; Drug: DDP; Drug: S-1

Interventions

SMART RADIATION

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

SMART & S-1/DDP

DDP DRUG

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

SMART & S-1/DDP

S-1 DRUG

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

SMART & S-1/DDP

Eligibility Criteria

• Age: 70 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

Related Publications (26)

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  BACKGROUND

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

S 1 (combination)

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Hui Liu, Professor

  Sun Yat-sen 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: November 14, 2015
• First Posted: November 17, 2015
• Study Start: July 1, 2015
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: September 4, 2020

Record last verified: 2020-09

Locations

CN (1)