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Simultaneous Modulated Accelerated Boost Versus Standard Dose Radiotherapy in Esophageal Cancer (SUMC-EC-002)

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ClinicalTrials.gov Identifier: NCT02556762
Recruitment Status : Recruiting
First Posted : September 22, 2015
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Chuangzhen Chen, Shantou University Medical College

Brief Summary:
This randomized phase III trial is to compare simultaneous modulated accelerated boost with standard dose radiotherapy given together with chemotherapy in treating patients with esophageal squamous cell carcinoma.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Radiation: Radiotherapy with simultaneous modulated accelerated boost Radiation: Standard dose radiotherapy Drug: PF Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Randomized Controlled Trial of Definite Chemoradiotherapy in Patients With Esophageal Cancer: Simultaneous Modulated Accelerated Boost Versus Standard Dose Radiotherapy
Study Start Date : August 2015
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SMART boost
Radiotherapy with simultaneous modulated accelerated boost
Radiation: Radiotherapy with simultaneous modulated accelerated boost
Radiotherapy: 66Gy/30F to the gross tumor and 50Gy/25 to subclinical diseases
Other Name: SIB

Drug: PF
Chemotherapy: Cisplatin and 5fluorouracil

Active Comparator: Standard dose RT
Standard dose radiotherapy
Radiation: Standard dose radiotherapy
Radiotherapy: 50Gy/25F to both gross tumor and subclinical disease

Drug: PF
Chemotherapy: Cisplatin and 5fluorouracil




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Local-regional control [ Time Frame: 2 years ]
  2. Distant metastasis-free survival [ Time Frame: 2 years ]
  3. Disease-free survival [ Time Frame: 2 years after randomization ]
  4. Acute and late toxicities using CTCAE v4.0 [ Time Frame: 2 years ]
    The probabilities of grade ≥ 3 acute toxicities and 2-year late toxicities of esophagus and lungs.

  5. Quality of life as assessed with FACT-E [ Time Frame: 2 years ]
    FACT-E score

  6. Quality of life as measured with EQ-5D [ Time Frame: 2 years ]
    The score of EQ-5D questionnaire

  7. Biomarkers [ Time Frame: 2 years ]


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

Inclusion Criteria:

  • Histologic proof of primary squamous cell carcinoma of the esophagus.
  • Primary disease at cervical, upper or middle thoracic esophagus
  • T1-4, N any, M0 (except supraclavicular lymph node).
  • Age≥18 & ≤75.
  • ECOG score 0-2.
  • Platelets ≥ 150,000, Hgb ≥ 10 gm%, ANC ≥ 1500, serum creatinine ≤ 1.5 mg/dl.
  • Adequate liver function.
  • Patients with prior malignancy are eligible if disease-free ≥ 5 years.
  • No prior chest radiotherapy, systemic chemotherapy or major esophageal surgery.
  • Signed study-specific informed consent form prior to study entry.

Exclusion Criteria:

  • Patients with tracheo-esophageal fistula.
  • Patients with invasion into mucosa of trachea or major bronchi.
  • Patients with uncontrolled serious medical or mental illnesses.
  • Prior RT that would result in overlap of planned RT fields.
  • Pregnancy or women of childbearing potential and men who are sexually active
  • Women who are breastfeeding a baby.

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 ClinicalTrials.gov identifier (NCT number): NCT02556762


Contacts
Contact: Ruihong Huang 15989849684@163.com
Contact: Jianzhou Chen, MD 86-13417049908 cjzeoeo@gmail.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    cjzeoeo@gmail.com   
Principal Investigator: Chuangzhen Chen, MD         
Sponsors and Collaborators
Chuangzhen Chen
Investigators
Principal Investigator: Chuangzhen Chen, MD Cancer Hospital, Shantou University Medical College

Responsible Party: Chuangzhen Chen, M.D, Shantou University Medical College
ClinicalTrials.gov Identifier: NCT02556762     History of Changes
Other Study ID Numbers: SUMC-EC-002
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018

Keywords provided by Chuangzhen Chen, Shantou University Medical College:
Esophageal cancer
Simultaneous modulated accelerated boost
Standard dose radiotherapy
Chemotherapy
Survival

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases