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Study of Simultaneous Modulated Accelerated Radiation Therapy Concurrent With Chemotherapy to Treat Esophageal Cancer

This study has been completed.
Information provided by (Responsible Party):
Chuangzhen Chen, Shantou University Medical College Identifier:
First received: August 12, 2012
Last updated: August 27, 2015
Last verified: August 2015
The purpose of this study is to evaluate the acute and 2-year late toxicities, the 2-year local control and overall survival rates in patients with esophageal squamous cell carcinoma receiving simultaneous modulated accelerated radiation therapy concurrent with chemotherapy.

Condition Intervention Phase
Esophageal Neoplasms
Radiation: SMART
Drug: PF
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Simultaneous Modulated Accelerated Radiation Therapy Concurrent With Chemotherapy in Patients With Esophageal Squamous Cell Carcinoma

Resource links provided by NLM:

Further study details as provided by Shantou University Medical College:

Primary Outcome Measures:
  • Toxicities [ Time Frame: The period during treatment and the 2 years after treatment ]
    The probabilities of grade ≥ 3 acute toxicities and 2-year late toxicities of esophagus and lungs.

Secondary Outcome Measures:
  • local control rate [ Time Frame: 2 years after treatment ]
  • overall survival rate [ Time Frame: 2 years after treatment ]

Enrollment: 85
Study Start Date: August 2012
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SMART combined with PF chemotherpay
SMART-base IMRT with concurrent and adjuvant chemotherapy(cisplatin and 5-fluorouracil)
Radiation: SMART
The PTV (planning target volume) of gross tumor will receive radiation dose of 66Gy, 2.2Gy per fraction and the PTV of subclinical disease will receive 54Gy, 1.8Gy per fraction,5 fraction per week.
Drug: PF
Concurrent and adjuvant chemotherapy: Cisplatin, 80mg/m2, intravenous on day 1, 5fluorouracil 0.5/m2, intravenous on d1 to d4. Two cycles during radiation treatment on d1 and d28. Two additional cycles after radiation treatment, 4 weeks per cycle.
Other Name: cisplatin plus 5fluorouracil

Detailed Description:

Esophageal cancer is one of the most common malignant diseases in China, especially in Chaoshan region. Concurrent chemoradiotherapy is the standard non-surgical treatment method for this disease and the radiation schedule is about 50.4~60 Gray (Gy) in total, 1.8~2Gy per fraction generally. However, although with such comprehensive method, noncontrol of local disease or recurrence is still the main reason of failure.

Most patients with esophageal cancer suffer from malnutrition. A number of factors including hypoxic, inflammation, radioresistance and accelerated repopulation may contribute to local failures of disease after treatment; therefore a higher radiation biological equivalent dose (BED) will improve the local control probability. Although the intergroup 0123 (INT123) trial had shown that simply increasing total radiation dose could not gain better local control or overall survival rate, however, the ability of this trial to test the potential benefits of higher radiation dose could be compromized by the deficiencies within them, such as, observation bias,large radiated target volume and usage of conventional radiation technique. In other words, the probability that increasing radiation may help improving the control of disease should not be denied.

Modern radiation techniques, such as intensity modulation radiation therapy (IMRT), specially, are able to improve the coverage of target volumes and sparing of critical structures, while increase the total radiation dose. By using simultaneous modulated accelerated radiation therapy (SMART) technique, the doses to the relevant normal organs per fraction could be reduced significantly, while the doses to tumor could be increased to higher than 2Gy. Thus reach the double goal of protection of normal tissues, increasing total radiation Equivalent Uniform Dose (EUD). Dosimetric study has proven the feasibility and superiority of SMART-base IMRT in radiation treatment of esophageal cancer, compared with conventional technique.

Overall, SMART-base IMRT concurrent with chemotherapy may improve the local control and overall survival rate of patients with esophageal cancer; Meanwhile, the acute and late toxicities would be tolerable and slighter than that of conventional technique.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • pathological proven diagnosis of primary squamous cell carcinoma of the esophagus
  • the primary disease located in cervical, upper or middle thoracic esophagus
  • no distant metastases
  • zubrod performance status: 0~2
  • life expectancy > 6 months; -absence of another malignancy
  • adequate liver, renal and bone marrow function
  • women of childbearing potential and male participants must practice adequate contraception
  • patient must provide study-specific informed consent prior to study entry

Exclusion Criteria:

  • evidence of tracheoesophageal or Mediastinal-esophageal fistula
  • prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years
  • prior radiation therapy that would result in overlap of planned radiation therapy fields; - Severe, active comorbidity
  • pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
  • women who are nursing
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Please refer to this study by its identifier: NCT01670409

China, Guangdong
Cancer Hospital, Shantou University Medical College
Shantou, Guangdong, China, 515031
Sponsors and Collaborators
Chuangzhen Chen
Principal Investigator: Chuangzhen Chen, MD Cancer Hospital, Shantou University Medical College
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Chuangzhen Chen, M.D., Shantou University Medical College Identifier: NCT01670409     History of Changes
Other Study ID Numbers: SUMC-ECA-001
ChiCTR-ONC-12002356 ( Registry Identifier: Chinese Clinical Trial Registry )
Study First Received: August 12, 2012
Last Updated: August 27, 2015

Keywords provided by Shantou University Medical College:
Esophageal squamous cell carcinoma

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on April 21, 2017