Clinical trial · Interventional
Phase II/III Study Compare Adjuvant Chemoradiotherapy, Radiotherapy and Surgery Alone for Esophageal Carcinoma
A Phase II/III Study of Adjuvant Chemoradiotherapy, Radiotherapy After Surgery Versus Surgery Alone in Patients With Stage ⅡB-Ⅲ Esophageal Carcinoma
NCT02279134CI-TRIAL-00044440unknownPhase 2 / Phase 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)
This phase III trial is studying how well the combination of chemoradiation or radiation works in resected locally advanced cancer of the esophagus or gastroesophageal junction.
Conditions
Conditions (2)
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 | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adjuvant Chemoradiation | Radiation | — | UNRESOLVED |
| Adjuvant Radiation | Radiation | — | UNRESOLVED |
| Cisplatin or Nedaplatin | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Surgery alone
- description
- No adjuvant treatment after radical resection is developed in this arm
- type
- EXPERIMENTAL
- label
- Adjuvant Chemoradiation
- description
- Adjuvant chemoradiation after radical resection is developed in this arm
- interventionNames
- Radiation: Adjuvant Chemoradiation
- Drug: Paclitaxel
- Drug: Cisplatin or Nedaplatin
- type
- ACTIVE_COMPARATOR
- label
- Adjuvant Radiation
- description
- Adjuvant radiation after radical resection is developed in this arm
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 68 Years
Show eligibility criteria text
Inclusion Criteria: 1. KPS≥70 2. Diagnosis of stage ⅡB or Ⅲ thoracic esophageal cancer 3. Complete resection 4. Adequate organ function: Hematopoietic Absolute granulocyte count at least 1,500/mm\^3 Platelet count at least 150,000/mm\^3 Hemoglobin at least 10 g/dL Hepatic Not specified Renal Creatinine no greater than 1.5 mg/dL AND/OR Creatinine clearance at least 65 mL/min Calcium no greater than 11 mg/dL Cardiovascular No uncontrolled heart disease No uncontrolled hypertension Exclusion Criteria: 1. Uncontrolled diabetes 2. Interval between surgery and adjuvant therapy more than 3 months 3. Sign of recurrence on CT scan or ultrasound or PET-CT No palpable subclavicular lymph nodes or involvement after cytology needle aspiration No lymph nodes greater than 1 cm on CT scan 4. With Weight loss greater than 10% from baseline 5. With other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix 6. Be pregnant
References
Publications (9)
- 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
- BACKGROUNDXiao ZF, Yang ZY, Miao YJ, Wang LH, Yin WB, Gu XZ, Zhang DC, Sun KL, Chen GY, He J. Influence of number of metastatic lymph nodes on survival of curative resected thoracic esophageal cancer patients and value of radiotherapy: report of 549 cases. Int J Radiat Oncol Biol Phys. 2005 May 1;62(1):82-90. doi: 10.1016/j.ijrobp.2004.08.046. PMID 15850906
- 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
- BACKGROUNDTeniere P, Hay JM, Fingerhut A, Fagniez PL. Postoperative radiation therapy does not increase survival after curative resection for squamous cell carcinoma of the middle and lower esophagus as shown by a multicenter controlled trial. French University Association for Surgical Research. Surg Gynecol Obstet. 1991 Aug;173(2):123-30. PMID 1925862
- BACKGROUNDFok M, Sham JS, Choy D, Cheng SW, Wong J. Postoperative radiotherapy for carcinoma of the esophagus: a prospective, randomized controlled study. Surgery. 1993 Feb;113(2):138-47. PMID 8430362
- BACKGROUNDZieren HU, Muller JM, Jacobi CA, Pichlmaier H, Muller RP, Staar S. Adjuvant postoperative radiation therapy after curative resection of squamous cell carcinoma of the thoracic esophagus: a prospective randomized study. World J Surg. 1995 May-Jun;19(3):444-9. doi: 10.1007/BF00299187.