SOX-based CRT for Esophageal Cancer.

NCT03991104 | Withdrawn Phase 1

• 1 other identifier: Zhejiang Provincal PH006
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Cancer

Keywords

esophageal cancer; chemoradiotherapy; oxaliplatin; S-1

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events

  Phase I: toxicities will be assessed based on the common toxicity criteria for adverse events version 4.0 (CTCAE v4.0).

  1 month

• Response rate

  Phase II: Response rate will be done after 4 weeks following the last radiotherapy session as evaluated by RECIST 1.1.

  1 month

Secondary Outcomes (4)

• Recommended dose of Oxaliplatin for phase II trial.

  1 month

• Number of Participants with Adverse Events (Phase II).

  6 months

• Overall survival time

  0-2 years

• Progression-free survival time

  0-2 years

Other Outcomes (2)

• Health-related Quality of life (HR-QoL, Phase II)

  0-2 years

• Health-related Quality of life (HR-QoL, Phase II)

  0-2 years

Study Arms (1)

SOX-based Chemoradiotherapy

EXPERIMENTAL

IMRT is delivered with a daily fraction of 1.8 Gy to a total dose of 50.4 Gy over 5 weeks. Concurrent Oxaliplatin (3 levels for phase I: 110mg/m², 120 mg/m² and 130 mg/m², d1) and fixed dose of S-1 (80mg/ m², d1-14) are administered concurrently with IMRT, every 4 weeks. The recommended dose of Oxaliplatin are then further evaluated in the Phase II setting.

Drug: Oxaliplatin; Drug: S-1 capsule; Radiation: Intensity modulated radiotherapy (IMRT)

Interventions

Oxaliplatin DRUG

Oxaliplatin (3 levels for phase I: 110 mg/m², 120 mg/m² and 130 mg/m²) is administered as a 2 h intravenous infusion in 500 mL of 5% glucose on day 1 and day 29 during the treatment course.

SOX-based Chemoradiotherapy

S-1 capsule DRUG

Patients received a fixed dose of S-1 with a dose of 80 mg/m2/d twice daily for 2 weeks, every 4 weeks.

SOX-based Chemoradiotherapy

Intensity modulated radiotherapy (IMRT) RADIATION

The total radiation dose was set to 50.4 Gy, which was given in 28 fractions of 1.8 Gy once-daily fractions for over 5 weeks.

SOX-based Chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≥4.0×109/L，a neutrophil count of ≥2.0×109/L, , a platelet count of ≥100×109/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.

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;
• 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;

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

Oxaliplatin; S 1 (combination); Radiotherapy, Intensity-Modulated

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)

Coordination Complexes; Organic Chemicals; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Radiation Oncology

Study Record Dates

• First Submitted: June 15, 2019
• First Posted: June 19, 2019
• Study Start: May 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

CN (1)