Clinical trial · Interventional
Efficacy of Intensity Modulated Radiation Therapy After Surgery in Early Stage of Esophageal Carcinoma;
Phase Ⅲ Study of Prophylactic Postoperative Intensity Modulated Radiation Therapy in Stage T2-3N0M0 Disease of Thoracic Esophageal Squamous Cell Carcinoma;
NCT01745107CI-TRIAL-00036839IMRTunknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer TNM Staging Distal Metastasis (M) M0 | — | UNRESOLVED | — |
| Esophageal Cancer TNM Staging Primary Tumor (T) T2 | — | UNRESOLVED | — |
| Esophageal Cancer TNM Staging Primary Tumor (T) T3 | — | UNRESOLVED | — |
| Esophageal Cancer TNM Staging Regional Lymph Nodes (N) N0 | — | UNRESOLVED | — |
| Esophageal Neoplasm | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prophylactic postoperative radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- surgery alone
- description
- No prophylactic postoperative radiation therapy,that is surgery alone is developed in this arm
- type
- EXPERIMENTAL
- label
- surgery plus radiation
- description
- Prophylactic postoperative radiation therapy is developed in this arm
- interventionNames
- Radiation: Prophylactic postoperative radiation therapy
Primary outcomes (1)
- measure
- Disease-free survival time
- timeFrame
- up to 3 years
- description
- including survival time from randomization to locoregional recurrence and to distal metastasis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 72 Years
Show eligibility criteria text
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;
References
Publications (19)
- BACKGROUNDXiao 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. PMID 12607634
- BACKGROUNDLin SH, Wang L, Myles B, Thall PF, Hofstetter WL, Swisher SG, Ajani JA, Cox JD, Komaki R, Liao Z. Propensity score-based comparison of long-term outcomes with 3-dimensional conformal radiotherapy vs intensity-modulated radiotherapy for esophageal cancer. Int J Radiat Oncol Biol Phys. 2012 Dec 1;84(5):1078-85. doi: 10.1016/j.ijrobp.2012.02.015. Epub 2012 Aug 3. PMID 22867894
- BACKGROUNDChen J, Zhu J, Pan J, Zhu K, Zheng X, Chen M, Wang J, Liao Z. Postoperative radiotherapy improved survival of poor prognostic squamous cell carcinoma esophagus. Ann Thorac Surg. 2010 Aug;90(2):435-42. doi: 10.1016/j.athoracsur.2010.04.002. PMID 20667325
- BACKGROUNDMariette C, Balon JM, Piessen G, Fabre S, Van Seuningen I, Triboulet JP. Pattern of recurrence following complete resection of esophageal carcinoma and factors predictive of recurrent disease. Cancer. 2003 Apr 1;97(7):1616-23. doi: 10.1002/cncr.11228. PMID 12655517
- BACKGROUNDNishimaki T, Suzuki T, Suzuki S, Kuwabara S, Hatakeyama K. Outcomes of extended radical esophagectomy for thoracic esophageal cancer. J Am Coll Surg. 1998 Mar;186(3):306-12. doi: 10.1016/s1072-7515(98)00013-1. PMID 9510261
- BACKGROUNDReeh M, Nentwich MF, von Loga K, Schade J, Uzunoglu FG, Koenig AM, Bockhorn M, Rosch T, Izbicki JR, Bogoevski D. An attempt at validation of the Seventh edition of the classification by the International Union Against Cancer for esophageal carcinoma. Ann Thorac Surg. 2012 Mar;93(3):890-6. doi: 10.1016/j.athoracsur.2011.11.035. Epub 2012 Jan 29. PMID 22289905
- Isono K, Sato H, Nakayama K. Results of a nationwide study on the three-field lymph node dissection of esophageal cancer. Oncology. 1991;48(5):411-20. doi: 10.1159/000226971.