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Comparison of Chemoradiotherapy and Chemoradiotherapy Combined With Consolidation Chemotherapy for ESCC

ConditionsEsophageal Squamous Cell CarcinomaChemotherapy EffectSide Effect of Drug
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe First Affiliated Hospital with Nanjing Medical University

About this trial

This study is a phase III, multicenter, prospective randomized controlled clinical study comparing the efficacy of non-surgical esophageal squamous cell carcinoma with radical chemoradiotherapy and radical chemoradiotherapy combined with consolidation chemotherapy. The survival time and side effects of patients were observed and compared.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-70 years old, not limited to male or female; at least able to take liquid diet;

Esophageal squamous cell carcinoma proved by histopathology;

Esophageal squamous cell carcinoma that is inoperable or refuses surgery,

According to the 2017 8th edition of AJCC esophageal cancer new staging criteria, the tumor is T2N0M0-TxNxM0 stage;

Disqualifiers

History of malignant tumors in other parts;

Duplicate carcinoma of the esophagus;

Pregnant or lactating patients;

Fertility but not using contraceptive measures;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Consolidation chemotherapy (4 courses)

    Combination product

    Consolidation chemotherapy (4 courses): After the concurrent chemoradiotherapy is over, after 2-3 weeks of rest, the patients in the consolidation chemotherapy group will be given 4 cycles of consolidation chemotherapy, and the chemotherapy regimen is the same as the concurrent chemotherapy regimen;

  • Concurrent chemotherapy (2 courses)

    Combination product

    Lipusu (T) + Cisplatin (DDP) program: T 135mg/m2 ivgtt, d1, 3week\*2cycles; DDP 75mg/m2 ivgtt, d2, 3week\*2cycles;

Treatment groups

1,216 Participants
are divided into 2 treatment groups
Group A: Group A: radical chemoradiotherapy group;Sham comparator 1 intervention
Group B: Group B: radical chemoradiotherapy combined with consolidation chemotherapy groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

3-years overall survival (OS)

Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.

Time frame
up to 3 years
2

5-years overall survival (OS)

Overall survival was measured from the initiation of chemotherapy to the date of the last follow-up or death.

Time frame
up to 5 years

Secondary outcomes

1

3-year progression-free survival (PFS)

The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death.

Time frame
up to 3 years
2

Objective response rate (ORR) Objective response rate (ORR)

Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission

Time frame
through study completion, an average of 36 month
3

5-year progression-free survival (PFS)

The PFS was calculated from the initiation of chemotherapy to the date of disease progression or death.

Time frame
up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital with Nanjing Medical University

Lead sponsor

Source ClinicalTrials.gov
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