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Phase Ⅲ Study of Prophylactic Postoperative Intensity Modulated Radiation Therapy in Stage T2-3N0M0 Disease of Thoracic Esophageal Squamous Cell Carcinoma;


Phase 3
40 Years
72 Years
Open (Enrolling)
Both
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

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Trial Information

Phase Ⅲ Study of Prophylactic Postoperative Intensity Modulated Radiation Therapy in Stage T2-3N0M0 Disease of Thoracic Esophageal Squamous Cell Carcinoma;


Although preoperative chemoradiation therapy followed by surgery is the most common approach
for patients with resectable esophageal cancer, the considerable number of esophageal cancer
patients received operation as the first treatment modality. Accordingly, postoperative
treatments have been playing an important role because of the poor survival rates of the
patients who have been treated with resection alone. The existing data shows that the 5-yeal
survival rate of stage T2-3N0M0(UICC 7th edition) of thoracic esophageal squamous cell
carcinoma(TESCC) after surgery is about 50% ,and locoregional lymph nodes metastases is
responsible for the main cause of failure while distal metastases account for relatively
less ratio. Therefore, the subclinical residual tumor is affirmative even if the early
disease has been undergone curable excision and local adjuvant treatment may be essential.
While we have proved the value of prophylactic radiation therapy after radical esophagectomy
for esophageal carcinoma with positive lymph node metastases and stage Ⅲ disease, there is
still lack of clear evidence for prophylactic radiation therapy in stage T2-3N0M0 disease
now. The comparison of conventional 2-dimensional radiotherapy after operation versus
surgery alone does not show statistically significant difference for stage T2-3N0M0 disease
in our previous report. In the precise radiotherapy setting, more and more evidences of
non-randomised control study indicate the trend or preliminary results of dosimetric
advantages of IMRT translating into substantive benefits in both survival and locoregional
control compared with 3- dimensional conformal and 2-dimensional conventional radiotherapy
for the treatment of esophageal carcinoma, but it remains to be confirmed in the randomized
control study that whether the IMRT is effective to improve the clinical outcomes of stage
T2-3N0M0 patients of TESCC. In view of this, we designed the randomized controlled trial to
determine the clinical efficacy and toxicity of prophylactic IMRT after surgery in stage
T2-3N0M0 disease of TESCC.


Inclusion Criteria:



- 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.

Exclusion Criteria:

- 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;

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival time

Outcome Description:

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

Outcome Time Frame:

up to 3 years

Safety Issue:

Yes

Principal Investigator

Zefen Xiao, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

China: Beijing Municipal Science and Technology Commission

Study ID:

Z121107001012004

NCT ID:

NCT01745107

Start Date:

November 2012

Completion Date:

November 2020

Related Keywords:

  • 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
  • T2-3N0M0 disease of esophageal neoplasm
  • postoperative radiotherapy
  • intensity modulated radiation therapy
  • survival
  • Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Esophageal Diseases
  • Esophageal Neoplasms
  • Neoplasm Metastasis

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