Efficacy of Intensity Modulated Radiation Therapy After Surgery in Early Stage of Esophageal Carcinoma;

NCT01745107 | Unknown Phase 3 DMC

• 1 other identifier: Z121107001012004
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the efficacy of preventive intensity modulated radiation therapy after surgery in stage T2-3N0M0 disease of thoracic esophageal squamous cell carcinoma(UICC 7th edition) and to identify the subgroup benefiting from the treatment.

Conditions

Esophageal Neoplasm; Esophageal Cancer TNM Staging Primary Tumor (T) T2; Esophageal Cancer TNM Staging Primary Tumor (T) T3; Esophageal Cancer TNM Staging Regional Lymph Nodes (N) N0; Esophageal Cancer TNM Staging Distal Metastasis (M) M0

Keywords

T2-3N0M0 disease of esophageal neoplasm; postoperative radiotherapy; intensity modulated radiation therapy; survival

Outcome Measures

Primary Outcomes (1)

• Disease-free survival time

  including survival time from randomization to locoregional recurrence and to distal metastasis

  up to 3 years

Secondary Outcomes (1)

• overall survival time

  up to 5 years

Study Arms (2)

surgery alone

NO INTERVENTION

No prophylactic postoperative radiation therapy,that is surgery alone is developed in this arm

surgery plus radiation

EXPERIMENTAL

Prophylactic postoperative radiation therapy is developed in this arm

Radiation: Prophylactic postoperative radiation therapy

Interventions

Prophylactic postoperative radiation therapy RADIATION

Prescription dose of 95%planning target volume(PTV) 50.4Gy/1.8Gy/28fractions for supraclavicular region and 95%PTV 56Gy/2Gy/28fractions for mediastinum which is delivered in 2 months after surgery.

Also known as: Preventive postoperative radiotherapy

surgery plus radiation

Eligibility Criteria

• Age: 40 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage T2-3N0M0 disease of TESCC patients confirmed by pathology studies who received R0 operations in Cancer Institute \& Hospital，CAMS；
• KPS≥70 before radiotherapy;
• Did not receive neoadjuvant or adjuvant treatment;
• No clear recurrent or metastatic lesions before radiotherapy;
• Intensity modulated radiation therapy(IMRT) is accepted;
• Regular follow-up.

You may not qualify if:

• Exploratory thoracotomy or palliative surgery;
• No clear recurrent or metastatic sites;
• Recurrence or metastasis is not certain;
• death of no definite cause.
• Irregular follow-up;

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead
• Sichuan Cancer Hospital and Research Institute: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator

Study Sites (1)

Cancer institute & Hospital，Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100021, China

Location

Related Publications (19)

• Xiao ZF, Yang ZY, Liang J, Miao YJ, Wang M, Yin WB, Gu XZ, Zhang DC, Zhang RG, Wang LJ. Value of radiotherapy after radical surgery for esophageal carcinoma: a report of 495 patients. Ann Thorac Surg. 2003 Feb;75(2):331-6. doi: 10.1016/s0003-4975(02)04401-6.

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  PMID: 11426751 BACKGROUND

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  PMID: 1925862 BACKGROUND

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  PMID: 8430362 BACKGROUND

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• Bedard EL, Inculet RI, Malthaner RA, Brecevic E, Vincent M, Dar R. The role of surgery and postoperative chemoradiation therapy in patients with lymph node positive esophageal carcinoma. Cancer. 2001 Jun 15;91(12):2423-30.

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• Qiao XY, Wang W, Zhou ZG, Gao XS, Chang JY. Comparison of efficacy of regional and extensive clinical target volumes in postoperative radiotherapy for esophageal squamous cell carcinoma. Int J Radiat Oncol Biol Phys. 2008 Feb 1;70(2):396-402. doi: 10.1016/j.ijrobp.2007.06.031. Epub 2007 Sep 12.

  PMID: 17855004 BACKGROUND

• Zhang Wencheng,Wang Qifeng,Xiao Zefen,et al.A efficacy analysis of intensity-modulated radiotherapy or three-dimensional conformal radiotherapy for resected thoracic esophageal squamous cell carcinoma.Chinese Journal of Radiation Oncology.2012,21(2):136-139.DOI:10.3760/cma.j.issn.1004-4221.2012.02.012.

  BACKGROUND

Related Links

• It is a national center for cancer research and treatment. It is one of the clinical trial bases approved by the Food and Drug Administration of State (SFDA)

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Zefen Xiao, MD

  The Department of Radiation Oncology ,Cancer Institute & Hospital，Chinese Academy of Medical Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 7, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2021
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

CN (1)