S-1 and Radiotherapy for Elderly Esophageal Cancer Patients

A Phase Ⅱ Study of S-1 With Concurrent Radiotherapy in Elderly Esophageal Cancer Patients

To investigate the efficacy and toxicity of S-1 with concurrent radiotherapy in older patients with esophageal cancer.

Study Overview

• Status: Withdrawn
• Conditions: Esophageal Cancer; Radiotherapy; S-1
• Intervention / Treatment: Drug: S-1; Radiation: radiotherapy

Detailed Description

Older patients with esophageal cancer have been correlated with poor prognosis because of having little chance to receive aggressive local therapy, including concurrent chemoradiotherapy. In this phase II trial, the efficacy and toxicity of S-1 with concurrent radiotherapy will be investigated in this setting.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Shiliang Lv, Dr; Phone Number: +8657787666666; Email: 547475708@qq.com
• Study Contact Backup: Name: Tao Song, MD; Phone Number: +8657187666666; Email: taosong01@hotmail.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Zhejiang Provincial People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Cytologically or histologically confirmed esophageal carcinoma;
2. ECOG performance status: 0-1;
3. No treatments prior to enrollment;
4. At least one measurable lesion on CT, MRI or esophageal barium exam;
5. Normal functions of heart, lung, liver, kidney and bone marrow;
6. Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL;
7. Informed consent signed.

Exclusion Criteria:

1. Prior treatments of chemotherapy or irradiation;
2. Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable;
3. Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis;
4. Participating in other clinical trials;
5. Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities;
6. The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Radiotherapy and S-1 arm; Radiotherapy will be delivered with a daily fraction of 1.8 Gy to a total dose of 50.4 Gy. Preplanned concurrent S-1 (70mg/m²/day) will be administered on Day 1 for 14 days, every 3 weeks. After dCRT, maintenance S-1 will be given up to two cycles.

Drug: S-1; S-1 will be administered orally twice daily for 14 days at a dose of 70 mg/m2/day with concurrent radiotherapy for 2 cycles. Patients who showed a response greater than that of stable disease underwent additional S-1 until disease progression, serious adverse events, or patient refusal up to four cycles.; Radiation: radiotherapy; Radiotherapy wiil be delivered with a daily fraction of 1.8 Gy to a total dose of 50.4 Gy.; Other Names: Irradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
response rate	Response rate will be done after 4 weeks following the last radiotherapy session.	week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival	Progression-free survival (PFS) will be calculated from the date of CCRT initiation to the date of documented failure (local recurrence or metastasis occurrence) or the date of the last follow-up for those remaining.	year 0 - year 2
Acute and late toxicities assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0)	Acute and late toxicities will be assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0).	year 0 - year 1
Overall survival	Overall survival (OS) wiil be determined as the time (in months) between the first day of therapy and the last follow-up or the date of death.	year 0 - year 2

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dysphagia score	Dysphagia score was measured according to the following scale: 0, able to consume a normal diet; 1, able to swallow certain solid foods; 2, able to swallow only semisolid foods; 3, able to swallow liquids only; and 4, unable to swallow anything.	month 0 - month 6

Collaborators and Investigators

• Sponsor: Zhejiang Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Estimated): December 1, 2019
• Study Completion (Estimated): December 1, 2020

Study Registration Dates

• First Submitted: February 11, 2016
• First Submitted That Met QC Criteria: March 22, 2016
• First Posted (Estimated): March 23, 2016

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Radiotherapy; S-1; Esophageal cancer; elder
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: ZhejiangPPH02