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

NCT01670409 | Completed Phase 2

• 2 other identifiers: SUMC-ECA-001ChiCTR-ONC-12002356
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Neoplasms

Keywords

Esophageal squamous cell carcinoma; SMART; IMRT; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Toxicities

  The probabilities of grade ≥ 3 acute toxicities and 2-year late toxicities of esophagus and lungs as assessed by CTCAE 4.0

  The period during treatment and the 2 years after treatment

Secondary Outcomes (3)

• Local control rate

  2 years after treatment

• overall survival rate

  2 years after treatment

• Complete blood count

  before radiation treatment and after every 5 fraction of radiotherapy (7 time points in total)

Study Arms (1)

SMART combined with PF chemotherpay

EXPERIMENTAL

SMART-base IMRT with concurrent and adjuvant chemotherapy(cisplatin and 5-fluorouracil)

Radiation: SMART; Drug: PF

Interventions

SMART RADIATION

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.

SMART combined with PF chemotherpay

PF DRUG

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.

Also known as: cisplatin plus 5fluorouracil

SMART combined with PF chemotherpay

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chuangzhen Chen: lead

Study Sites (1)

Cancer Hospital, Shantou University Medical College

Shantou, Guangdong, 515031, China

Location

Related Publications (2)

• Liu W, Zeng C, Wang S, Zhan Y, Huang R, Luo T, Peng G, Wu Y, Qiu Z, Li D, Wu F, Chen C. A combined predicting model for benign esophageal stenosis after simultaneous integrated boost in esophageal squamous cell carcinoma patients (GASTO1072). Front Oncol. 2022 Dec 22;12:1026305. doi: 10.3389/fonc.2022.1026305. eCollection 2022.

  PMID: 37078004 DERIVED

• Zhang WZ, Chen JZ, Li DR, Chen ZJ, Guo H, Zhuang TT, Li DS, Zhou MZ, Chen CZ. Simultaneous modulated accelerated radiation therapy for esophageal cancer: a feasibility study. World J Gastroenterol. 2014 Oct 14;20(38):13973-80. doi: 10.3748/wjg.v20.i38.13973.

  PMID: 25320535 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma

Interventions

Cisplatin; Fluorouracil

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Chuangzhen Chen, MD

  Cancer Hospital, Shantou University Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 12, 2012
• First Posted: August 22, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: January 3, 2022

Record last verified: 2021-12

Locations

CN (1)