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Esophageal NeoplasmsPhase 4NCT02721563

A Trial of CMNa Combined With Definitive Concurrent Chemoradiotherapy for Locally Advanced ESCC

A Phase 4 study testing Sodium Glycididazole in people with Esophageal Neoplasms, run by Shandong Cancer Hospital and Institute at 10 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a perspective, multicenter,randomized controlled trial to evaluate the efficacy and safety of treatment with CMNa combined with concurrent chemoradiotherapy in patients with locally advanced 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?
Yes, some participants may receive a placebo
How many people
77 participants
Where
10 sitesChina
Study dates
25 Feb 2016to 30 Jun 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 ESCC in upper and middle thoracic segment（stage II-III）confirmed by imaging and pathology or cytology, which is unsuitable or refuse surgery;
  • Capable for chemo-radiotherapy;
  • The existence of measurable lesions;
  • ECOG PS of 0 or 1
  • Possible semi-liquid diet;
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  • Expected lifetime≥3 months
  • normal bone marrow reserve: ANCcount ≥1500/mm3;platelet count ≥100,000/ mm3,hemoglobin≥9g/dl
  • normal hepatic funcion: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

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
  • Primary lesions were multifocal
  • Patients who have obvious esophageal ulcers or have above moderate pains in chest-back or have symptoms of esophageal perforation
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  • 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

10 sites in 1 country.

10 sites in 1 country

China10 sites

  • Qianfoshan Hospital of Shandong

    Jinan, Shandong, 250117

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250117

  • Shandong Cancer Hospital and Institute

    Jinan, Shandong, 250117

  • Jining NO.1 People's Hospital

    Jining, Shandong, 250117

  • Liaocheng People 's 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 Random Trial of Sodium Glycididazole Combined With Definitive Concurrent Chemoradiotherapy for Locally Advanced Squamous Cell Esophageal Carcinoma

This is a perspective, multicenter,randomized controlled trial to evaluate the efficacy and safety of treatment with CMNa combined with concurrent chemoradiotherapy in patients with locally advanced 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 safty 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 104 cases.

Being tested
Sodium Glycididazole, Placebo
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 700mg/m2.Three times a week (once every other one day),before radiation therapy, total 6 weeks.

  • PlaceboDrug

    Placebo:three times a week (once every other one day),before radiation therapy, total 6 weeks.

Study groups in NCT02721563
Study groupRoleWhat they receive
Sodium GlycididazoleActive comparatorSodium 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,T60Gy/30f,week 1-6
Receives: Drug: Sodium Glycididazole
Control GroupPlacebo comparatorPlacebo：dissolved in 100mlphysiological saline(Now with chef),ivgtt,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, total 6 weeks course.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, 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,T60Gy/30f,week 1-6
Receives: Drug: Placebo

What is being measured

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

  1. Objective response rate

    Measured: 3 months

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 start25 Feb 2016
  3. Primary completion10 Jun 2018
  4. Study completion30 Jun 2018

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02721563
Sponsor's protocol ID
CMNAER2
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

Publications

  • Li X, Zhao H, Xie P, Zhu W, Liu L, Wu P, Sheng Y, Wang C, Song Y, Meng X, Zhang J, Xing L. Sodium glycididazole combined with definitive chemoradiotherapy for patients with esophageal squamous cell carcinoma: A multicenter randomized clinical trial. Precis Radiat Oncol. 2026 Feb 25;10(1):19-26. doi: 10.1002/pro6.70052. eCollection 2026 Mar.

    PubMed 42022351

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 10 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 12 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: finished, 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 10 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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: 3 months). 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 NCT02721563, which also lists 1 linked publication.

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.

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