Different Radiation Dose With Concurrent Chemotherapy for Thoracic Esophageal Carcinoma

Last updated: June 12, 2023
Sponsor: Peking University Cancer Hospital & Institute
Overall Status: Completed

Phase

N/A

Condition

Digestive System Neoplasms

Esophageal Cancer

Esophageal Disorders

Treatment

Standard-dose

High-dose

Clinical Study ID

NCT02850991
ESR-15-11224
  • Ages 18-75
  • All Genders

Study 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. 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Signed informed consent form
  2. Age: 18-75 years
  3. Histological or cytologic diagnosis of esophageal squamous cell carcinoma within onemonth. Clinical stage T1-4 N0-1 M0-1a (AJCC 6th edition). Supraclavicular lymphaticmetastasis or abdominal lymph node metastasis for mid-thoracic also can be included
  4. Karnofsky performance status scores: ≥70
  5. Without any prior anticancer therapy
  6. BMI≥18kg/m2 or weight loss ≤5% within 3 months
  7. 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 renalfunction (within 14 days): Total bilirubin <1.5 x upper limit of normal (ULN), Alanineaminopeptidase and Aspartase aminotransferase ≤ 2.5 x ULN, creatinine ≤ 1.5xULN
  8. 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; nosymptomatic heart disease, including myocardial ischemia, congestive heart failure oruncontrolled arrhythmias, roughly normal electrocardiogram; LVEF ≥ 50%,or can receivechemoradiotherapy assessed by cardiologists

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 167
Treatment Group(s): 2
Primary Treatment: Standard-dose
Phase:
Study Start date:
April 01, 2016
Estimated Completion Date:
April 30, 2022

Study Description

PRIMARY OBJECTIVES:

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

SECONDARY OBJECTIVES:

I. 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.

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Site Not Available

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