A Trial of CMNa Combined With Concurrent Chemoradiotherapy for Locally Recurrent ESCC

NCT ID: NCT02721576

Last Updated: 2019-10-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-05
• Study Completion Date: 2018-07-30

Brief Summary

This is a perspective, multicenter,single arm, open study to evaluate the efficacy and safety of treatment with CMNa combined with concurrent chemoradiotherapy in patients with locally recurrent squamous cell esophageal carcinoma . Analyses of primary objective (ORR) will be done as defined in the protocol.

Detailed Description

The primary end point of this study is objective response rate.The secondary end point is OS, PFS and the safety of drug. The primary hypothesis is the CMNa will improve ORR and thus improve OS, PFS. Assuming bilateral a=0.05, statistical power of 80%. The total sample size is 40 cases.

Conditions

Esophageal Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sodium Glycididazole

Sodium Glycididazole：800mg/m2，finished in 30 minutes,within 60 minutes after intravenous drip for radiation therapy.Three times a week (once every other one day),before radiation therapy. Chemotherapy Paclitaxel:45 mg/m²,d1,week 1-6 Cisplatin:20 mg/m²,d1,week 1-6 OR Docetaxel: 75 mg / m², 1 day or divided into D1, D8 days, 21 days / cycle. Cisplatin: 75 mg / m², divided into D1-D3 days or D1-D5 days, 21 days / cycle. Or nedaplatin: 80 mg / m², 21 days / cycle.

OR 5-FU: 500 mg / m² / day, divided into D1 ~ D5 for use, 21 days / cycle. Cisplatin: 75 mg / m² / day, divided into D1-D3 day or D1-D5 days, 21 days / cycle. Or nedaplatin: 80 mg / m², 21 days / cycle 3DCRT/IMRT:2.0Gy/f/day,T>40Gy/20f,week 1->5

Group Type: EXPERIMENTAL

Sodium Glycididazole

Intervention Type: DRUG

Sodium Glycididazole 800mg/m2.Three times a week (once every other one day),before radiation therapy, total 5-6 weeks.

Interventions

Sodium Glycididazole

Sodium Glycididazole 800mg/m2.Three times a week (once every other one day),before radiation therapy, total 5-6 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Signed written informed consent prior to study entry

2. Patients with recurrent ESCC after radiotherapy, confirmed by imaging and pathology or cytology;

3. Capable for chemo-radiotherapy;

4. The existence of measurable lesions;

5. ECOG PS of 0 or 1

6. Possible semi-liquid diet;

7. Expected lifetime≥3 months

8. normal bone marrow reserve: ANC count ≥1500/mm3;platelet count ≥100,000/ mm3,hemoglobin≥9g/dl

9. normal hepatic function:bilirubin level ≤1.5×ULN;AST/ALT≤1.5×ULN

10. normal renal function: serum creatinine≤1.5mg/dl and calculated creatinine clearance ≥60ml/min

11. Normal cardiac function

12. Subjects tumor tissue available for the relevant biomarker detection

13. Clinical stage: No distant metastasis

Exclusion Criteria

1. Female subject who is during pregnancy or lactation, and the subject who have fertility don't take effective contraception during study

2. Any mental illness or nervous system lesions or can't tell treatment response clearly (such as cerebrovascular accident sequelae)

3. Any serious uncontrolled disease and infection, such as severe heart, liver, kidney diseases or diabetes, can't complete the treatment plan

4. Patients who have other malignant lesions, except curable skin cancer (non-melanoma skin cancer),carcinoma in situ of cervix or serve disease cured for 5 years

5. Patients with distant metastasis.

6. Patients who have obvious esophageal ulcers or have above moderate pains in chest-back or have symptoms of esophageal perforation

7. received anti-cancer treatment of esophageal cancer before the group, including surgery, radiotherapy, chemotherapy (induction of chemotherapy before the group is greater than or equal to two cycles)

8. Not esophageal squamous carcinoma confirmed by pathology or cytology

9. History of active hepatitis

10. Unable to comprehend the study requirement or who are not likely to comply with the study requirements

11. Significant disease which, in the investigator's opinion, would exclude the patient from the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong Cancer Hospital and Institute

OTHER

Sponsor Role: lead

Responsible Party

Jinming Yu

president

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jinming Yu, Ph.D, M.D

Role: PRINCIPAL_INVESTIGATOR

Shandong Cancer Hospital and Institute

Locations

Qianfoshan Hospital of Shandong

Jinan, Shandong, China

Shandong Cancer Hospital and Institute

Jinan, Shandong, China

Jining NO.1 People's Hospital

Jining, Shandong, China

Liaocheng People Hospital

Liaocheng, Shandong, China

Qingdao Center Medical Group

Qingdao, Shandong, China

Rizhao City People 's Hospital

Rizhao, Shandong, China

Fei Cheng People's Hospital

Tai’an, Shandong, China

An Qiu People's Hospital

Weifang, Shandong, China

The Fourth People's Hospitalof Zibo

Zibo, Shandong, China

Countries

China

Other Identifiers

CMNAER3

Identifier Type: -

Identifier Source: org_study_id