Back to results

Chemoradiotherapy of Capecitabine With or Without Oxaliplatin Versus Cisplatin-5-FU for Esophageal Squamous Cancer (CRTCOESC)

Primary Purpose

Stage III Esophageal Squamous Cell Carcinoma, Stage II Esophageal Squamous Cell Carcinoma

Status

Active

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Capecitabine(Aibin)

Oxaliplatin(Aiheng)

Radiotherapy

About this trial

This is an interventional treatment trial for Stage III Esophageal Squamous Cell Carcinoma focused on measuring Chemoradiotherapy， Esophageal Squamous Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

age 18-75years old
Histologically proven squamous cell carcinoma of the esophagus the tumor was in T2-4N0-2M0
The patients have not received the surgery or chemo-radiotherapy.
Hb≥80g/L, absolute neutrophil count ≥1.5×109/L, Plt≥90×109/L,
ALT、AST≤2.5*N,Cr≤1.5*N.
performance status score 0-2

Exclusion Criteria:

pregnant, lactating women
Oxaliplatin or fluorouracil Allergy or metabolic disorders
Radiotherapy contraindications
History of organ transplantation
Brain metastasis
The peripheral nervous system disorders
Severe infection
Oral capecitabine who have difficulty with,such as dysphagia,The activities of digestive ulcer, Gastrointestinal bleeding
Severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,high blood pressure, diabetes.
Other malignant tumor in recent 5 years.

Sites / Locations

The First Affiliated Hospital of Henan University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Capecitabine-oxaliplatin-radiotherapy

cisplatin with 5-FU and radiotherapy

Capecitabine and radiotherapy

Arm Description

oxaliplatin：65mg/m2，d1，8，22, 29,I.V.or d1, 8, 22, 29, 43, 50, 64, 71,I.V.plus,capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks or 12 weeks in total. radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.

cisplatin: 75mg/m2 d1，29 or d1, 29, 57, 85, 5-Fu：750mg/m2 CIV24h d1-4，d29-32 or d1-4，d29-32, d57-60, d85-88. radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.

capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks or 12 weeks in total, radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.

Outcomes

Primary Outcome Measures

Grade 3/5 acute toxicities

Grade 3/5 acute toxicities occurred during or within 90 days after RT

OS-2 year

Overall Survival rate in 2 year from Randomization

Secondary Outcome Measures

PFS-2 year

Progression Free Survival rate in 2 year from Randomization

overall remission rate, ORR

overall remission rate after CRT

quality of life, Qol

quality of life evaluation

pathologic complete response rate

pathologic complete response rate confirmed by gastroscope biopsy

Full Information

NCT ID

NCT02025036

First Posted

November 17, 2013

Last Updated

February 3, 2023

Sponsor

The First Affiliated Hospital of Henan University of Science and Technology

Collaborators

Luoyang Central Hospital, Military 150 Hospital, Anyang Cancer Hospital, Nanyang Central Hospital, Henan Oncology Hospital, The First Affiliated Hospital of Xinyang Medical College, Sanmenxia Central Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02025036

Brief Title

Chemoradiotherapy of Capecitabine With or Without Oxaliplatin Versus Cisplatin-5-FU for Esophageal Squamous Cancer

Acronym

CRTCOESC

Official Title

Three-arm Phase III Trial Comparing Radiotherapy With Different Chemotherapy Regimens for Esophageal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 2014 (Actual)

Primary Completion Date

September 13, 2022 (Actual)

Study Completion Date

April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The First Affiliated Hospital of Henan University of Science and Technology

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

A three-arm Phase III trial was started in Oct. 2014. Definitive chemoradiotherapy with cisplatin plus 5-fluorouracil is the standard in Western countries in esophagus cancer. But in China because of its toxic reaction, most of patients stop the halfway. Because low toxicity, the chemotherapy regimen of capecitabine with or without oxaliplatin are widely used in clinical. The purpose of this study is to confirm the difference of Capecitabine plus with or without oxaliplatin over cisplatin plus 5-fluorouracil with definitive chemoradiotherapy for esophagus squamous cell carcinoma. A total of 249 patients will be accrued from China within 2 years. The primary endpoints are grade 3-5 AEs and overall survival and the secondary endpoints include progression-free survival, response rate, pathologic complete response rate.

Detailed Description

We plan to recruit the patients who were pathologically confirmed with esophageal squamous cell carcinoma from the Oct 2014. The patients will be divided into three groups.Experimental group 1 : single drug Capecitabine and concurrent radiotherapy.Experimental group 2: Capecitabine plus oxaliplatin and concurrent radiotherapy. Control group:cisplatin plus 5-fluorouracil and concurrent radiotherapy. To evaluate the adverse events and the overall survival of the three group. Also observe the patient's progression-free survival, response rate, pathologic complete response rate.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stage III Esophageal Squamous Cell Carcinoma, Stage II Esophageal Squamous Cell Carcinoma

Keywords

Chemoradiotherapy， Esophageal Squamous Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

249 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Capecitabine-oxaliplatin-radiotherapy

Arm Type

Experimental

Arm Description

Arm Title

cisplatin with 5-FU and radiotherapy

Arm Type

Active Comparator

Arm Description

cisplatin: 75mg/m2 d1，29 or d1, 29, 57, 85, 5-Fu：750mg/m2 CIV24h d1-4，d29-32 or d1-4，d29-32, d57-60, d85-88. radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.

Arm Title

Capecitabine and radiotherapy

Arm Type

Experimental

Arm Description

capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks or 12 weeks in total, radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.

Intervention Type

Drug

Intervention Name(s)

Capecitabine(Aibin)

Other Intervention Name(s)

Aibin

Intervention Description

capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 weeks in total

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin(Aiheng)

Other Intervention Name(s)

Aiheng

Intervention Description

Oxaliplatin(Aiheng)：65mg/m2，d1，8, 22, 29,I.V.

Intervention Type

Radiation

Intervention Name(s)

Radiotherapy

Other Intervention Name(s)

Radiation Therapy

Intervention Description

concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity

Primary Outcome Measure Information:

Title

Grade 3/5 acute toxicities

Description

Grade 3/5 acute toxicities occurred during or within 90 days after RT

Time Frame

90 days

Title

OS-2 year

Description

Overall Survival rate in 2 year from Randomization

Time Frame

2 years

Secondary Outcome Measure Information:

Title

PFS-2 year

Description

Progression Free Survival rate in 2 year from Randomization

Time Frame

2 years

Title

overall remission rate, ORR

Description

overall remission rate after CRT

Time Frame

16 weeks

Title

quality of life, Qol

Description

quality of life evaluation

Time Frame

16 weeks

Title

pathologic complete response rate

Description

pathologic complete response rate confirmed by gastroscope biopsy

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age 18-75years old Histologically proven squamous cell carcinoma of the esophagus the tumor was in T2-4N0-2M0 The patients have not received the surgery or chemo-radiotherapy. Hb≥80g/L, absolute neutrophil count ≥1.5×109/L, Plt≥90×109/L, ALT、AST≤2.5*N,Cr≤1.5*N. performance status score 0-2 Exclusion Criteria: pregnant, lactating women Oxaliplatin or fluorouracil Allergy or metabolic disorders Radiotherapy contraindications History of organ transplantation Brain metastasis The peripheral nervous system disorders Severe infection Oral capecitabine who have difficulty with,such as dysphagia,The activities of digestive ulcer, Gastrointestinal bleeding Severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,high blood pressure, diabetes. Other malignant tumor in recent 5 years.

Overall Study Officials: