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Esophageal Squamous Cell CarcinomaPhase 3NCT02399306

Chemoradiotherapy With or Without Enteral Nutrition for Locally Advanced Thoracic Esophageal Carcinoma

A Phase 3 study testing Enteral nutrition and radiotherapy in people with Esophageal Squamous Cell Carcinoma and Enteral Nutrition Therapy, run by Sichuan Cancer Hospital and Research Institute at 1 site 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 randomized, prospective, multicenter study. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Enteral nutrition and radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
222 participants
Where
1 siteChina
Study dates
Sep 2014to Oct 2017
Phase
Phase 3
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

  • 18 to 75 years old
  • male or femalePathologically or cytologically proven esophageal squamous cell carcinoma
  • Clinical stage II or stage III
  • PG-SGA≧2
  • Karnofsky performance score(KPS) ≧70
  • Estimated life expectancy of at least 12 weeks
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  • Hemoglobin≥90.0g/dL,white blood cell count（WBC）≥ 4000 cells/mm³,Platelet count≥100,000 cells/mm³
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 times upper limit of normal,bilirubin normal
  • Creatinine normal OR creatinine clearance ≥ 60 mL/min
  • Patients have good compliance to treatment and follow-up of acceptance
  • Forced expiratory volume in one second（FEV1） ≥ 1.5 litre or ≥ 75% of the reference value
  • the functions of the heart, kidney, liver were basically normal, with no chemotherapy and radiotherapy contraindications

Who cannot join

  • Patients with severely bowel function impaired or can not tolerate enteral nutrition
  • Patients with serious gastrointestinal obstruction, be unable to take food by mouth and can not / do not want to a feeding tube inserted
  • Patients have no risk of malnutrition
  • Patients have severe malnutrition (weight loss >10% or <30 g/L, BMI<18.5 kg/m2 or hemoglobin<90 g/L before the treatment
  • Patients who have severe vomiting, gastrointestinal bleeding, intestinal obstruction
  • Patients can not tolerate chemotherapy and radiotherapy
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  • Patients who have distant metastasis
  • The primary tumor or lymph node already received surgical treatment (except for biopsy);
  • Patient who received radiotherapy for primary tumor or lymph node;
  • Patient who received chemotherapy or immunotherapy;
  • Patient who suffered from other malignant tumor;
  • Patient who have taken other drug test within 1 month;
  • Pregnant woman or Lactating Women and Women in productive age who refuse to take contraception in observation period;
  • Subject with a severe allergic history or idiosyncratic;
  • Subject with severe pulmonary and cardiopathic disease history;
  • Refuse or incapable to sign the informed consent form of participating this trial;
  • Drug abuse or alcohol addicted;
  • Subject with a Personality or psychiatric diseases, people with no legal capacity or people with limited capacity for civil conduct;

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sichuan Cancer Hospital & Institute

    Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: A Prospective, Multicenter, Randomized Controlled Study to Compare Chemoradiotherapy With or Without Enteral Nutrition Intervention for Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma

This is a randomized, prospective, multicenter study.

Read the detailed description

This is a randomized, prospective, multicenter study. The aim of this study was to compare the changes of body weight,survival,toxicity,quality of life and opportunistic infection frequency in Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma between and after chemoradiotherapy with or without enteral nutrition therapy.

Being tested
Enteral nutrition, radiotherapy
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

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

  • Enteral nutritionDrug

    Patients in the Trial Group received concurrent chemoradiotherapy and standardized, whole-course enteral nutrition management.

  • radiotherapyRadiation

    Patients receive intensity modulated radiation therapy(IMRT) from week 1 to week 7,once a day, 5 times per week.

    Radiotherapy dose：95% gross tumor volume（GTV-T） 60-66 Gy /30-33f，GTV-N 60-66 Gy /30-33f，CTV-T 50-54 Gy /25-27f，CTV-N 50-54 Gy /25-27f.

Study groups in NCT02399306
Study groupRoleWhat they receive
Arm AExperimentalchemoradiotherapy with Enteral Nutrition intervention
Receives: Drug: Enteral nutrition; Radiation: radiotherapy
Arm BPlacebo comparatorchemoradiotherapy
Receives: Radiation: radiotherapy

What is being measured

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

  1. Body Weight Change from baseline to the end of treatment

    Body weight change from baseline to the end of treatment = body weight at the end of treatment - baseline body weight.

    Measured: up to 1 month after the treatment

Secondary outcomes (6)

  1. Maximum Body Weight Change during treatment

    Maximum body weight change during treatment= the lowest body weight during treatment - baseline body weight.

    Measured: up to 1 month after the treatment

  2. Blood biochemical examination

    albumin, haemoglobin,et al

    Measured: up to 1 month after the treatment

  3. Grade 3-5 toxicity

    Grade 3-5 adverse events as assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 andthe criteria of the Radiation Therapy Oncology Group ，such as esophagitis、pneumonitis 、hematologic toxicity and infection rate

    Measured: up to 1 month after the treatment

  4. Completion rate of chemoradiotherapy

    The proportion of people who complete all treatment as required

    Measured: up to 1 month after the treatment

  5. short-term effect

    objective remission rate

    Measured: up to 1 month after the treatment

  6. Overall Survival

    overall survival

    Measured: at least 2 years

Timeline

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

  1. First posted26 Mar 2015 (estimated)
  2. Study startSep 2014
  3. Primary completionOct 2017
  4. Study completionOct 2017

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
222 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02399306
Sponsor's protocol ID
scch2015001
Status last verified
Mar 2020
First submitted
17 Mar 2015
Last updated
17 Mar 2020
Results posted
No
Data monitoring committee
No

Publications

  • Lyu J, Shi A, Li T, Li J, Zhao R, Zhu S, Wang J, Xing L, Yang D, Xie C, Shen L, Zhang H, Zhu G, Wang J, Pan W, Li F, Lang J, Shi H. Effects of Enteral Nutrition on Patients With Oesophageal Carcinoma Treated With Concurrent Chemoradiotherapy: A Prospective, Multicentre, Randomised, Controlled Study. Front Oncol. 2022 Feb 25;12:839516. doi: 10.3389/fonc.2022.839516. eCollection 2022.

    PubMed 35280748

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Enteral nutrition and radiotherapy in people with Esophageal Squamous Cell Carcinoma and Enteral Nutrition Therapy, run by Sichuan Cancer Hospital and Research Institute at 1 site 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 18 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 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Body Weight Change from baseline to the end of treatment (time frame: up to 1 month after the treatment). 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 NCT02399306, 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 17 Mar 2020.

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