Comparison of Chemoradiotherapy and Chemoradiotherapy Combined With Consolidation Chemotherapy for ESCC

• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05775419
• Collaborator: (none)
• Enrollment: 1,216
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 84
• Patients Per Site Per Month: 14.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Squamous Cell Carcinoma; Chemotherapy Effect; Side Effect of Drug	Combination Product: Consolidation chemotherapy (4 courses); Combination Product: Concurrent chemotherapy (2 courses)	N/A

Detailed Description

Test grouping:

Group A: radical chemoradiotherapy group; Group B: radical chemoradiotherapy combined with consolidation chemotherapy group;

Specific chemotherapy regimens:

Concurrent chemotherapy (2 courses): Lipusu (T) + Cisplatin (DDP) scheme: T 135mg/m2 ivgtt, d1, 3week2cycles; DDP 75mg/m2 ivgtt, d2, 3week2cycles; 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; Radiotherapy scheme: intensity modulated radiotherapy PTV50-54Gy, PGTV 56-60Gy, conventional fractionation.

Primary efficacy endpoints: 3-year overall survival (OS), 5-year overall survival (OS) Secondary efficacy endpoints: 3-year progression-free survival (PFS), 5-year progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), toxic and side effects, and patient quality of life

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1216 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective Randomized Controlled Clinical Study Comparing Curative Effect of Non-surgical Esophageal Squamous Cell Carcinoma With Radical Chemoradiotherapy and Radical Chemoradiotherapy Combined With Consolidation Chemotherapy
• Actual Study Start Date: Jun 30, 2021
• Anticipated Primary Completion Date: Jun 30, 2025
• Anticipated Study Completion Date: Jun 30, 2028

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Group A: radical chemoradiotherapy group; Concurrent chemotherapy (2 courses): Lipusu (T) + Cisplatin (DDP) scheme: T 135mg/m2 ivgtt, d1, 3week*2cycles; DDP 75mg/m2 ivgtt, d2, 3week*2cycles; Radiotherapy scheme: intensity modulated radiotherapy PTV50-54Gy, PGTV 56-60Gy, conventional fractionation.	Combination Product: Concurrent chemotherapy (2 courses); Lipusu (T) + Cisplatin (DDP) program: T 135mg/m2 ivgtt, d1, 3week*2cycles; DDP 75mg/m2 ivgtt, d2, 3week*2cycles;
Experimental: Group B: radical chemoradiotherapy combined with consolidation chemotherapy group 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; Radiotherapy scheme: intensity modulated radiotherapy PTV50-54Gy, PGTV 56-60Gy, conventional fractionation.	Combination Product: Consolidation chemotherapy (4 courses); 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;

Outcome Measures

Primary Outcome Measures

1. 3-years overall survival (OS) [up to 3 years]

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

2. 5-years overall survival (OS) [up to 5 years]

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

Secondary Outcome Measures

1. 3-year progression-free survival (PFS) [up to 3 years]

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

2. Objective response rate (ORR) Objective response rate (ORR) [through study completion, an average of 36 month]

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

3. 5-year progression-free survival (PFS) [up to 5 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

2. Esophageal squamous cell carcinoma proved by histopathology;

3. Esophageal squamous cell carcinoma that is inoperable or refuses surgery,

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

5. ECOG 0-1; life expectancy > 6 months;

6. No chemotherapy was used before selection;

7. No history of radiotherapy;

8. No surgical treatment;

9. No serious allergic history;

10. Hemoglobin 100 g/L, WBC3.5109/L, neutrophils 1.5109, platelets 100109/L; CR1.5 upper limit of normal, TB2.5 upper limit of normal, AST and ALT2.5 upper normal limit, AKP2.5 upper normal limit ; Be able to understand the research and have signed the informed consent;

Exclusion Criteria:

1. History of malignant tumors in other parts;

2. Duplicate carcinoma of the esophagus;

3. Pregnant or lactating patients;

4. Fertility but not using contraceptive measures;

5. Serious comorbidities: very high-risk hypertension, severe pulmonary function impairment, massive myocardial infarction, cardiac function ≥ grade II, mental history and severe diabetes;

6. During the active period of infectious diseases;

7. Participate in other clinical trials at present or within four weeks before enrollment;

8. Simultaneous treatment with other anti-cancer drugs (including anti-cancer traditional Chinese medicine);

9. After esophageal stent placement;

10. Cases with perforation tendency;

11. Have a history of organ transplantation.

12. Widespread metastases throughout the body, including lung, liver, bone, and intracranial metastases;

13. Known or suspected allergic to chemotherapy drugs; According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu	China	210009

Sponsors and Collaborators

• The First Affiliated Hospital with Nanjing Medical University

Investigators

• Study Director: Xiaolin GE, MM, The First Affiliated Hospital with Nanjing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The First Affiliated Hospital with Nanjing Medical University
• ClinicalTrials.gov Identifier: NCT05775419
• Other Study ID Numbers: GXL-003
• First Posted: Mar 20, 2023
• Last Update Posted: Mar 20, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma; Drug-Related Side Effects and Adverse Reactions

Study Results

No Results Posted as of Mar 20, 2023