S-1 and Radiotherapy for Elderly Esophageal Cancer Patients

NCT02716688 | Withdrawn Phase 2

• 1 other identifier: ZhejiangPPH02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Esophageal Cancer; S-1; Radiotherapy

Keywords

Esophageal cancer; Radiotherapy; elder; S-1

Outcome Measures

Primary Outcomes (1)

• response rate

  Response rate will be done after 4 weeks following the last radiotherapy session.

  week 4

Secondary Outcomes (3)

• Progression-free survival

  year 0 - year 2

• Acute and late toxicities assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0)

  year 0 - year 1

• Overall survival

  year 0 - year 2

Other Outcomes (1)

• Dysphagia score

  month 0 - month 6

Study Arms (1)

Radiotherapy and S-1 arm

EXPERIMENTAL

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; Radiation: radiotherapy

Interventions

S-1 DRUG

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.

Radiotherapy and S-1 arm

radiotherapy RADIATION

Radiotherapy wiil be delivered with a daily fraction of 1.8 Gy to a total dose of 50.4 Gy.

Also known as: Irradiation

Radiotherapy and S-1 arm

Eligibility Criteria

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

You may qualify if:

• Cytologically or histologically confirmed esophageal carcinoma;
• ECOG performance status: 0-1;
• No treatments prior to enrollment;
• At least one measurable lesion on CT, MRI or esophageal barium exam;
• Normal functions of heart, lung, liver, kidney and bone marrow;
• 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;
• Informed consent signed.

You may not qualify if:

• Prior treatments of chemotherapy or irradiation;
• Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable;
• Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis;
• Participating in other clinical trials;
• 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;
• 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.

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: lead

Study Sites (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

S 1 (combination); Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Phenomena

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: MD

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: March 23, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: September 22, 2023

Record last verified: 2023-09

Locations

CN (1)