Different Radiation Dose With Concurrent Chemotherapy for Thoracic Esophageal Carcinoma

NCT02850991 | Completed DMC

• 1 other identifier: ESR-15-11224
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Cancer

Keywords

Esophageal cancer, radiation, chemotherapy

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  5 years

Secondary Outcomes (1)

• Progression-free survival

  5 years

Other Outcomes (1)

• local control rate, recurrence pattern

  5 years

Study Arms (2)

High-dose

EXPERIMENTAL

concurrent 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.

Radiation: High-dose

Standard-dose

ACTIVE COMPARATOR

concurrent 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.

Radiation: Standard-dose

Interventions

High-dose RADIATION

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

High-dose

Standard-dose RADIATION

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

Standard-dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Anhui Shi, MD.

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: High dose radiation plus chemotherapy of paclitaxel and carboplatin vs standard dose radiation plus chemotherapy of paclitaxel and carboplatin.

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 1, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2022
• Last Updated: June 13, 2023

Record last verified: 2023-06

Locations

CN (1)