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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Shantou University Medical College
Sponsor:
Information provided by (Responsible Party):
Chuangzhen Chen, Shantou University Medical College
ClinicalTrials.gov Identifier:
NCT01670409
First received: August 12, 2012
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • overall survival rate [ Time Frame: 2 years after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: August 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670409

Contacts
Contact: Jianzhou Chen, MD 86-13417049908 cjz8080@163.com
Contact: Chuangzhen Chen, MD 86-13923995569 stccz@139.com

Locations
China, Guangdong
Cancer Hospital, Shantou University Medical College Recruiting
Shantou, Guangdong, China, 515031
Contact: Chuangzhen Chen, MD    86-13923995569    stccz@139.com   
Contact: Jianzhou Chen, MD    86-13417049908    cjz8080@163.com   
Principal Investigator: Chuangzhen Chen, MD         
Sponsors and Collaborators
Chuangzhen Chen
Investigators
Principal Investigator: Chuangzhen Chen, MD Cancer Hospital, Shantou University Medical College
  More Information

No publications provided

Responsible Party: Chuangzhen Chen, M.D., Shantou University Medical College
ClinicalTrials.gov Identifier: NCT01670409     History of Changes
Other Study ID Numbers: SUMC-ECA-001, ChiCTR-ONC-12002356
Study First Received: August 12, 2012
Last Updated: May 29, 2013
Health Authority: China: Ethics Committee

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

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014