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Esophageal CancerNCT02850991

Different Radiation Dose With Concurrent Chemotherapy for Thoracic Esophageal Carcinoma

A study testing High-dose and Standard-dose in people with Esophageal Cancer, run by Peking University Cancer Hospital & 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

Definitive chemoradiation is the standard treatment for locally advanced esophageal cancer. NCCN (National Comprehensive Cancer Network) recommends radiation dose of 50-50.4 Gy as the definitive radiation dose for esophageal cancer with definitive chemo-radiation. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Cancer
What is being tested?
High-dose and Standard-dose
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
167 participants
Where
1 siteChina
Study dates
Apr 2016to Apr 2022
Phase
Interventional
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 informed consent form
  • Age: 18-75 years
  • Histological or cytologic diagnosis of esophageal squamous cell carcinoma within one month. Clinical stage T1-4 N0-1 M0-1a (AJCC 6th edition）. Supraclavicular lymphatic metastasis or abdominal lymph node metastasis for mid-thoracic also can be included
  • Karnofsky performance status scores: ≥70
  • Without any prior anticancer therapy
  • BMI≥18kg/m2 or weight loss ≤5% within 3 months
  • Adequate marrow function (within 7 days): White blood cell ≥ 3×109/L,Neutrophils (ANC) ≥1.5×109/L, Platelet count ≥100×109/L, Hemoglobin ≥90g/L. Normal hepatic and renal function (within 14 days): Total bilirubin <1.5 x upper limit of normal (ULN), Alanine aminopeptidase and Aspartase aminotransferase ≤ 2.5 x ULN, creatinine ≤ 1.5xULN
  • Normal cardiac and pulmonary function: Forced expiratory volume at one second (FEV1) ≥1.0 L or FEV1/FVC ≥ 50% pre FEV1; No myocardial infarction within 1 year; no symptomatic heart disease, including myocardial ischemia, congestive heart failure or uncontrolled arrhythmias, roughly normal electrocardiogram; LVEF ≥ 50%，or can receive chemoradiotherapy assessed by cardiologists

Who cannot join

  • Other or mixed pathological type
  • The second primary tumor of esophageal cancer located outside the radiation area
  • Biopsy-proven invasion of the tracheobronchial tree or tracheoesophageal fistula
  • Mid-thoracic esophageal cancer with supraclavicular lymphatic metastasis and abdominal lymph node metastasis; other metastasis
  • Within 2cm of the gastroesophageal junction
  • Prior chemotherapy, prior thoracic radiation, surgical resection or target therapy of the primary tumor
Show all 10Show fewer
  • Significant medical or psychiatric illnesses that in the physician's judgment (uncontrolled coronary heart disease, cardiomyopathy and/or heart failure requiring hospitalization. Uncontrolled hypertension or history of myocardial infarction within one year. Uncontrolled diabetes mellitus. Acute bacterial or fungal infection requiring intravenous antibiotics. Acute exacerbation of chronic obstructive pulmonary disease (COPD) or other pulmonary disease requiring hospitalization influencing tumor treatment
  • Refused to sign informed consent form
  • Concurrent pregnancy or lactation
  • History of a second malignancy other than nonmelanoma skin cancer, and cervical cancer in situ.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

Other trials in China

About this study

Official title: A Multicenter, Prospective, Randomized, Phase III Trial Evaluating High-dose Versus Standard-dose Radiation With Concurrent Chemotherapy for Thoracic Esophageal Squamous Cell Carcinoma

Definitive chemoradiation is the standard treatment for locally advanced esophageal cancer. NCCN (National Comprehensive Cancer Network) recommends radiation dose of 50-50.4 Gy as the definitive radiation dose for esophageal cancer with definitive chemo-radiation. However, as many studies in China showed that the most common recurrence site after definitive chemo-radiation was within the radiation region. But there have not been large randomized clinical trials to investigate the optimal radiation dose with concurrent chemotherapy for esophageal cancer in China. The purpose of this clinical trial is to investigate the optimal radiation dose for thoracic esophageal squamous cell cancer with definitive concurrent chemoradiotherapy.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine if high-dose radiation with concurrent chemotherapy increases overall survival for thoracic esophageal squamous cell carcinoma

SECONDARY OBJECTIVES:

  1. To evaluate if high-dose radiation with concurrent chemotherapy increased progression-free survival for thoracic esophageal squamous cell carcinoma II.To evaluate if high-dose radiation with concurrent chemotherapy increased local control for thoracic esophageal squamous cell carcinoma

OUTLINE:

Patients are randomized to one of the two treatment arms

ARM 1:Patients receive high-dose radiation with concurrent chemotherapy.High-dose RT:59.4 Gy in 33 fractions, 1.8 Gy per fraction, 5days/week.concurrent chemotherapy: Paclitaxel 50mg/m2 D1+carboplatin AUC (area under curve) =2 D1, weekly for 6 weeks. After that, patients receive consolidative platinum-based 3-week chemotherapy for 2 cycles.

ARM 2:Patients receive standard-dose radiation with concurrent chemotherapy.Standard-dose RT:59.4 Gy in 33 fractions, 1.8 Gy per fraction, 5days/week . Concurrent chemotherapy: Paclitaxel 50 mg/m2 D1+carboplatin AUC (area under curve) =2 D1, weekly for 6 weeks. After that, patients receive consolidative platinum-based 3-week chemotherapy for 2 cycles.

After completion of study therapy, patients are followed up every 3-4 months for 2 years, then every 6 months for 3 years.

Being tested
High-dose, Standard-dose
Keywords
Esophageal cancer, radiation, chemotherapy
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • High-doseRadiation

    Drug: concurrent chemotherapy with radiation paclitaxel plus carboplatin are used weekly in both arms

  • Standard-doseRadiation

    Drug: concurrent chemotherapy with radiation paclitaxel plus carboplatin are used weekly in both arms

Study groups in NCT02850991
Study groupRoleWhat they receive
High-doseExperimentalconcurrent chemoradiotherapy High-dose RT:59.4 Gy in 33 fractions, 1.8 Gy per fraction, 5days/week; CT: Paclitaxel 50 mg/m2 D1+carboplatin AUC (area under curve) =2 D1, weekly for 6 weeks. After that, patients receive consolidative platinum-based 3-week chemotherapy for 2 cycles.
Receives: Radiation: High-dose
Standard-doseActive comparatorconcurrent chemoradiotherapy Standard-dose RT:50.4 Gy in 28 fractions, 1.8Gy per fraction, 5days/week; CT: Paclitaxel 50 mg/m2 D1+carboplatin AUC (area under curve) =2 D1, weekly for 6 weeks. After that, patients receive consolidative platinum-based 3-week chemotherapy for 2 cycles.
Receives: Radiation: Standard-dose

What is being measured

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

  1. Overall Survival

    Measured: 5 years

Secondary outcomes (1)

  1. Progression-free survival

    Measured: 5 years

Timeline

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

  1. First posted1 Aug 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionApr 2019
  4. Study completionApr 2022

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
High dose radiation plus chemotherapy of paclitaxel and carboplatin vs standard dose radiation plus chemotherapy of paclitaxel and carboplatin.
Masking
Single blind
Who is masked
Investigator
Enrolment
167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02850991
Sponsor's protocol ID
ESR-15-11224
Status last verified
Jun 2023
First submitted
28 Jul 2016
Last updated
13 Jun 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing High-dose and Standard-dose in people with Esophageal Cancer, run by Peking University Cancer Hospital & 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 8 inclusion and 10 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 13 Jun 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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?

Overall Survival (time frame: 5 years). 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 NCT02850991.

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 13 Jun 2023; AzTrials last refreshed its copy on 7 Nov 2026.

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