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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01670409
Recruitment Status : Completed
First Posted : August 22, 2012
Last Update Posted : August 28, 2015
Information provided by (Responsible Party):
Chuangzhen Chen, Shantou University Medical College

Brief Summary:
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 or disease Intervention/treatment Phase
Esophageal Neoplasms Radiation: SMART Drug: PF Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2012
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. local control rate [ Time Frame: 2 years after treatment ]
  2. overall survival rate [ Time Frame: 2 years after treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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 )
First Posted: August 22, 2012    Key Record Dates
Last Update Posted: August 28, 2015
Last Verified: August 2015

Keywords provided by Chuangzhen Chen, 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