AzTrials
AzTrials

Esophageal NeoplasmsPhase 4NCT02721576

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

A Phase 4 study testing Sodium Glycididazole in people with Esophageal Neoplasms, run by Shandong Cancer Hospital and Institute at 9 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Neoplasms
What is being tested?
Sodium Glycididazole
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
9 sitesChina
Study dates
5 Jul 2016to 30 Jul 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed written informed consent prior to study entry
  • Patients with recurrent ESCC after radiotherapy, confirmed by imaging and pathology or cytology;
  • Capable for chemo-radiotherapy;
  • The existence of measurable lesions;
  • ECOG PS of 0 or 1
  • Possible semi-liquid diet;
Show all 13Show fewer
  • Expected lifetime≥3 months
  • normal bone marrow reserve: ANC count ≥1500/mm3;platelet count ≥100,000/ mm3,hemoglobin≥9g/dl
  • normal hepatic function:bilirubin level ≤1.5×ULN;AST/ALT≤1.5×ULN
  • normal renal function: serum creatinine≤1.5mg/dl and calculated creatinine clearance ≥60ml/min
  • Normal cardiac function
  • Subjects tumor tissue available for the relevant biomarker detection
  • Clinical stage: No distant metastasis

Who cannot join

  • Female subject who is during pregnancy or lactation, and the subject who have fertility don't take effective contraception during study
  • Any mental illness or nervous system lesions or can't tell treatment response clearly (such as cerebrovascular accident sequelae)
  • Any serious uncontrolled disease and infection, such as severe heart, liver, kidney diseases or diabetes, can't complete the treatment plan
  • 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
  • Patients with distant metastasis.
  • Patients who have obvious esophageal ulcers or have above moderate pains in chest-back or have symptoms of esophageal perforation
Show all 11Show fewer
  • 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)
  • Not esophageal squamous carcinoma confirmed by pathology or cytology
  • History of active hepatitis
  • Unable to comprehend the study requirement or who are not likely to comply with the study requirements
  • Significant disease which, in the investigator's opinion, would exclude the patient from the study

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

China9 sites

  • Qianfoshan Hospital of Shandong

    Jinan, Shandong, 250117

  • Shandong Cancer Hospital and Institute

    Jinan, Shandong, 250117

  • Jining NO.1 People's Hospital

    Jining, Shandong, 250117

  • Liaocheng People Hospital

    Liaocheng, Shandong

  • Qingdao Center Medical Group

    Qingdao, Shandong, 250117

  • Rizhao City People 's Hospital

    Rizhao, Shandong

  • Fei Cheng People's Hospital

    Tai’an, Shandong, 250117

  • An Qiu People's Hospital

    Weifang, Shandong, 250117

  • The Fourth People's Hospitalof Zibo

    Zibo, Shandong, 250117

Other trials in China

About this study

Official title: A Perspective Trial of Sodium Glycididazole Combined With Concurrent Chemoradiotherapy for Locally Recurrent Squamous Cell Esophageal Carcinoma

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.

Read the 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.

Being tested
Sodium Glycididazole
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sodium GlycididazoleDrug

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

Study groups in NCT02721576
Study groupRoleWhat they receive
Sodium GlycididazoleExperimentalSodium 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
Receives: Drug: Sodium Glycididazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate

    Measured: up to 3 month

Secondary outcomes (2)

  1. Overall survival

    Measured: 36 months

  2. Progression free survival

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2016 (estimated)
  2. Study start5 Jul 2016
  3. Primary completion30 Jun 2018
  4. Study completion30 Jul 2018

Why it stopped: The number of enrolled cases is too small.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02721576
Sponsor's protocol ID
CMNAER3
Status last verified
Oct 2019
First submitted
9 Mar 2016
Last updated
11 Oct 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sodium Glycididazole in people with Esophageal Neoplasms, run by Shandong Cancer Hospital and Institute at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 11 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The number of enrolled cases is too small.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: up to 3 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02721576.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in