SOX-based CRT for Esophageal Cancer.

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    45
  • sponsor
    Zhejiang Provincial People's Hospital
Updated on 23 January 2021
platelet count
cancer
oxaliplatin
neutrophil count
esophageal cancer
a hemoglobin
esophagus cancer

Summary

Patients with esophageal cancer that had locally advanced diseases or with unresectable diseases are being asked to participate in this phase I/II study.

This phase I/II study is being conducted to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and efficacy of IMRT combined with S-1 and Oxaliplatin (SOX) based chemotherapy for unresectable locally advanced esophageal cancer.

Description

Esophageal carcinoma (EC) remains difficult to cure with overall 5-year survival rates for locally advanced stages being poor. Definitive concurrent chemoradiotherapy (dCRT) remains the mainstay of treatment for locally advanced and unresectable EC. Oxaliplatin is a new generation platinum with a more preferable toxicity profile compared to cisplatin. Furthermore, S-1 combines 5-Fu prodrug (tegafur) and two modulators of 5-Fu metabolism, gimeracil (CDHP) and oteracil. Basic studies showed that S-1 has superior anti-cancer effects than 5-Fu and enhances the sensitivity of cancer cells to the effects of radiotherapy. Herein, we designed a prospective phase I/II study, which is combined S-1 and oxaliplatin with IMRT for the patients with locally advanced and unresectable esophageal cancer, and evaluated the tolerability and efficacy of this combination.

<Phase I>

Primary Objective:

To establish the safety of combination chemotherapy comprising oxaliplatin (escalating doses: 110, 120, 130 mg/m2, day 1 and day 29), fixed dose of S-1 (80 mg/m2, day1-14 and day 29-42) and IMRT (5040cGy/28fx/5W+) in unresectable locally advanced esophageal cancer.

Secondary Objective:

To observe the efficacy of this regimen in these patients.

<Phase II>

Primary Objective:

To assess the response rate of combination chemotherapy comprising oxaliplatin (recommended dose determined in phase I study, day1 and day29), fixed dose of S-1 (80 mg/m2, day1-14 and day 29-42), and IMRT (5040cGy/28fx/5W+) in unresectable locally advanced esophageal cancer.

Secondary Objectives:

To determine the adverse reactions of this regimen in these patients. To determine PFS(Progression free survival) of patients treated with this regimen.

To determine OS (overall survival) of patients treated with this regimen. To explore the Health-related Quality of life using EORTC QLQ-C30 and EORTC QLQ-OES18 in these patients.

Details
Condition Esophageal Diseases, Esophageal Cancer, head and neck cancer, Esophageal Carcinoma, Esophageal Disorders, esophagus cancer, oesophageal cancer, cancer of the esophagus, oesophageal carcinoma
Treatment Oxaliplatin, intensity modulated radiotherapy (IMRT), S-1 capsule
Clinical Study IdentifierNCT03991104
SponsorZhejiang Provincial People's Hospital
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Gender: Male or Female
Do you have Esophageal Cancer?
Do you have any of these conditions: oesophageal carcinoma or Esophageal Cancer or Esophageal Disorders or cancer of the esophagus or Esophageal Carcinoma or oesophageal cancer or head an...?
Cytopathological confirmed esophageal cancer with unresectable locally advanced diseases
Age of 18-70
ECOG performance status: 0-1
No treatments prior to enrollment
Patients must have measurable or evaluable disease with at least one tumor mass maximum diameter 10mm by multi-slice spiral CT or MR scan. Imaging exam must be performed within 15 days from enrollment
Normal marrow function and the blood tests must be collected within 7 days from enrollment with a hemoglobin of 90g/L, an white blood cell (WBC) counts of 4.0109/La neutrophil count of 2.0109/L, , a platelet count of 100109/L, a total bilirubin (TBil) of 1.0 upper normal limitation (UNL), a creatinine (Cr) of 1.0 UNL, alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of 2.5 UNL, Alkaline phosphatase (AKP) 5.0 UNL. Pulmonary function (FEV1 >1L), and no major electrocardiogram abnormalities
Normal electrocardiogram results and no history of congestive heart failure
Patients must be with good compliance and agree to accept follow-up of disease progression and adverse events
Informed consent signed

Exclusion Criteria

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
Pregnancy, breast feeding, or not adopting birth control
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
Weight loss of 20% or more of normal body weight within 3 months
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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