Clinical trial · Interventional
Radiotherapy Combined With S-1/DDP for Elderly Esophageal Squamous Cell Cancer.
A Prospective, Single-arm Study of Simultaneous Modulated Accelerated Radiotherapy Combined With S-1/DDP for Elderly Esophageal Squamous Cell Carcinoma.
NCT02606916CI-TRIAL-00046982completedPhase 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)
This Prospective, single-arm Phase Ⅱ study is to determine the efficacy and safety of Once-daily Simultaneous Modulated Accelerated Radiotherapy combined with S-1/DDP for geratic esophageal squamous cell carcinoma patients.
Conditions
Conditions (1)
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 Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DDP | Drug | Cisplatin | ALIAS |
| S-1 | Drug | — | UNRESOLVED |
| SMART | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SMART & S-1/DDP
- description
- Patients in experimental group receive daily simultaneous modulated accelerated radiotherapy combined with DDP and S-1.
- interventionNames
- Radiation: SMART
- Drug: DDP
- Drug: S-1
Primary outcomes (1)
- measure
- Clinical response rate
- timeFrame
- 2-year
- description
- the percentage of patients who had partial remission or complete remission after chemoradiotherapy
Secondary outcomes (3)
- measure
- progression-free survival
- timeFrame
- 3-year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically or cytologically confirmed esophageal squamous cell carcinoma. * Stage II-IVa ESCC confirmed by endoscopic ultrasonography(EUS) and imaging studies. * Aging from 70 to 80. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Charlson's weighted index of comorbidities (WIC) ≤4； * White blood cell count ≥4×109 /L, neutrophile granulocyte count≥1.5×109 /L, platelet count≥100×109 /L, hemoglobin ≥100 g /L, serum creatinine and bilirubin 1.5 times less than the upper limits of normal (ULN),aminotransferase two times less than the ULN. * Weight loss ≤15% within the past half year. * Forced expiratory volume in 1 s≥ 1 L. * Patients and their family signed the informed consents. Exclusion Criteria: * Previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ. * Already received antineoplastic therapy,including chemotherapy, radiotherapy or operation. * Any contraindication for chemotherapy or radiotherapy(such as a myocardial infarction within 6 months,immunosuppressive therapy,symptomatic heart disease,including unstable angina pectoris, congestive heart failure,and uncontrolled arrhythmia.) * Malignant pleural effusion or pericardial effusion. * Weight loss \>10% within the past 3 months. * Recruited in other clinical trials within 30 days * Drug addiction, long-term alcohol abuse and AIDS patients. * Uncontrollable epileptic attack or psychotic patients without self-control ability. * Severe allergy or idiosyncrasy. * Not suitable for this study judged by researchers.
References
Publications (26)
- BACKGROUNDCooper JS, Guo MD, Herskovic A, Macdonald JS, Martenson JA Jr, Al-Sarraf M, Byhardt R, Russell AH, Beitler JJ, Spencer S, Asbell SO, Graham MV, Leichman LL. Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective randomized trial (RTOG 85-01). Radiation Therapy Oncology Group. JAMA. 1999 May 5;281(17):1623-7. doi: 10.1001/jama.281.17.1623. PMID 10235156
- BACKGROUNDMinsky BD, Pajak TF, Ginsberg RJ, Pisansky TM, Martenson J, Komaki R, Okawara G, Rosenthal SA, Kelsen DP. INT 0123 (Radiation Therapy Oncology Group 94-05) phase III trial of combined-modality therapy for esophageal cancer: high-dose versus standard-dose radiation therapy. J Clin Oncol. 2002 Mar 1;20(5):1167-74. doi: 10.1200/JCO.2002.20.5.1167. PMID 11870157
- BACKGROUNDSteyerberg EW, Neville B, Weeks JC, Earle CC. Referral patterns, treatment choices, and outcomes in locoregional esophageal cancer: a population-based analysis of elderly patients. J Clin Oncol. 2007 Jun 10;25(17):2389-96. doi: 10.1200/JCO.2006.09.7931. PMID 17557952
- BACKGROUNDStahl M, Stuschke M, Lehmann N, Meyer HJ, Walz MK, Seeber S, Klump B, Budach W, Teichmann R, Schmitt M, Schmitt G, Franke C, Wilke H. Chemoradiation with and without surgery in patients with locally advanced squamous cell carcinoma of the esophagus. J Clin Oncol. 2005 Apr 1;23(10):2310-7. doi: 10.1200/JCO.2005.00.034. PMID 15800321
- BACKGROUNDBedenne L, Michel P, Bouche O, Milan C, Mariette C, Conroy T, Pezet D, Roullet B, Seitz JF, Herr JP, Paillot B, Arveux P, Bonnetain F, Binquet C. Chemoradiation followed by surgery compared with chemoradiation alone in squamous cancer of the esophagus: FFCD 9102. J Clin Oncol. 2007 Apr 1;25(10):1160-8. doi: 10.1200/JCO.2005.04.7118. PMID 17401004
- 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.