Clinical trial · Interventional
Phase II Study of Neo-adjuvant Chemoradiotherapy for Squamous Cell Esophageal Cancer
Phase II Study of Optimum Design of Neo-adjuvant Chemoradiotherapy Followed by Surgery for Squamous Cell Esophageal Cancer
NCT02938195CI-TRIAL-00024350unknownPhase 2ClinicalTrials.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 investigators designed a new preoperative chemoradiotherapy regimen to focus on the most important radiation area and hope to reduce the radiation volume and try to reduce the postoperative mortality and treatment-related mortality.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemoradiation | — | UNRESOLVED | — |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| radiotherapy | Radiation | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- experimental arm
- description
- PF regimen (cis-platinum of 25 mg/m2/d, d1-3; 5-fluorouracil of 500mg/m2/d, d1-4) every 4 weeks for 2 cycles concurrently with three-dimensional radiation therapy or intensity-modulated radiotherapy followed by surgery 4-8weeks after neoadjuvant therapy in a standard manner.
- interventionNames
- Radiation: radiotherapy
- Procedure: Surgery
Primary outcomes (1)
- measure
- Percentage of patients completing adjuvant chemoradiotherapy and surgery
- timeFrame
- 4-8weeks after surgery
Secondary outcomes (2)
- measure
- Percentage of R0 resection
- timeFrame
- 4-8weeks after surgery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage IIB or III, which is potentially resectable. 2. Patients must not have received any prior anticancer therapy. 3. More than 6 months of expected survival. 4. Age ranges from 18 to 70 years. 5. Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney. 6. Karnofsky performance status (KPS) of 90 or more. 7. Signed informed consent document on file. Exclusion Criteria: 1. Patients are diagnosed or suspected to be allergic to cisplatin or 5-Fu. 2. Patients with concomitant hemorrhagic disease. 3. Pregnant or breast feeding. 4. Inability to use gastric conduit after esophagectomy because of a prior surgery. 5. Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more. 6. Have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the cervix, nonmelanoma skin cancer or cured early stage of prostate cancer.
References
Publications (7)
- BACKGROUNDShapiro J, van Lanschot JJB, Hulshof MCCM, van Hagen P, van Berge Henegouwen MI, Wijnhoven BPL, van Laarhoven HWM, Nieuwenhuijzen GAP, Hospers GAP, Bonenkamp JJ, Cuesta MA, Blaisse RJB, Busch ORC, Ten Kate FJW, Creemers GM, Punt CJA, Plukker JTM, Verheul HMW, Bilgen EJS, van Dekken H, van der Sangen MJC, Rozema T, Biermann K, Beukema JC, Piet AHM, van Rij CM, Reinders JG, Tilanus HW, Steyerberg EW, van der Gaast A; CROSS study group. Neoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial. Lancet Oncol. 2015 Sep;16(9):1090-1098. doi: 10.1016/S1470-2045(15)00040-6. Epub 2015 Aug 5. PMID 26254683
- BACKGROUNDvan Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088. PMID 22646630
- BACKGROUNDHuang TC, Hsu CH, Lin CC, Tu YK. Systematic review and network meta-analysis: neoadjuvant chemoradiotherapy for locoregional esophageal cancer. Jpn J Clin Oncol. 2015 Nov;45(11):1023-8. doi: 10.1093/jjco/hyv119. Epub 2015 Aug 5. PMID 26246479
- BACKGROUNDMartinek J, Akiyama JI, Vackova Z, Furnari M, Savarino E, Weijs TJ, Valitova E, van der Horst S, Ruurda JP, Goense L, Triadafilopoulos G. Current treatment options for esophageal diseases. Ann N Y Acad Sci. 2016 Oct;1381(1):139-151. doi: 10.1111/nyas.13146. Epub 2016 Jul 8. PMID 27391867
- BACKGROUNDIkebe M, Morita M, Yamamoto M, Toh Y. Neoadjuvant therapy for advanced esophageal cancer: the impact on surgical management. Gen Thorac Cardiovasc Surg. 2016 Jul;64(7):386-94. doi: 10.1007/s11748-016-0655-y. Epub 2016 May 10.