Clinical trial · Interventional
A Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer
A Multicenter Randomized Phase-II Study Of Raltitrexed/Oxaliplatin Plus Radiotherapy Versus Radiotherapy In Subjects With Inoperable Esophageal Cancer
NCT01732380CI-TRIAL-00008525unknownPhase 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 aim of this study was to compare raltitrexed/oxaliplatin plus radiotherapy versus radiotherapy in subjects with inoperable esophageal cancer.
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 |
|---|---|---|---|
| Inoperable Esophageal Cancer Stage I-III | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
| Raltitrexed | Drug | Raltitrexed | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Radiotherapy
- description
- Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer
- interventionNames
- Radiation: Radiotherapy
- type
- EXPERIMENTAL
- label
- Raltitrexed/Oxaliplatin Plus Radiotherapy
- description
- Raltitrexed 2.5mg/㎡ d1,Oxaliplatin 100mg/㎡ d1,q21d Plus Radiotherapy 2.0Gy/day, 5 times/week,6 weeks In Subjects With Inoperable esophageal cancer
- interventionNames
- Drug: Raltitrexed
- Drug: Oxaliplatin
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- Progression-Free-Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of inoperable esophageal cancer(squamous cell carcinoma) * Measurable disease according to RECIST criteria * Age \> 18 years * WHO performance score \< 2 * Estimated life expectancy of \> 12 weeks * Subjects will be considered appropriate to receive systemic chemotherapy and pelvic radiotherapy * Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL * Renal function: Cr ≤ 1.25×UNL * Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL * Documented informed consent to participate in the trial Exclusion Criteria: * Subjects with distant metastases * Pregnancy or breast feeding. Women of childbearing age must use effective contraception * Serious cardiovascular disease (congestive heart failure, uncontrollable arrhythmia, unstable angina, myocardial infarction, serious heart valve disease, resistant hypertension) * Evidence of bleeding diathesis or serious infection * pregnant or lactating woman * Patient participation in other studies
References
Publications (5)
- BACKGROUNDCourrech Staal EF, Aleman BM, Boot H, van Velthuysen ML, van Tinteren H, van Sandick JW. Systematic review of the benefits and risks of neoadjuvant chemoradiation for oesophageal cancer. Br J Surg. 2010 Oct;97(10):1482-96. doi: 10.1002/bjs.7175. PMID 20645400
- BACKGROUNDGebski V, Burmeister B, Smithers BM, Foo K, Zalcberg J, Simes J; Australasian Gastro-Intestinal Trials Group. Survival benefits from neoadjuvant chemoradiotherapy or chemotherapy in oesophageal carcinoma: a meta-analysis. Lancet Oncol. 2007 Mar;8(3):226-34. doi: 10.1016/S1470-2045(07)70039-6. PMID 17329193
- BACKGROUNDMcKenzie S, Mailey B, Artinyan A, Metchikian M, Shibata S, Kernstine K, Kim J. Improved outcomes in the management of esophageal cancer with the addition of surgical resection to chemoradiation therapy. Ann Surg Oncol. 2011 Feb;18(2):551-8. doi: 10.1245/s10434-010-1314-7. Epub 2010 Sep 14. PMID 20839062
- BACKGROUNDSeitz JF, Bennouna J, Paillot B, Gamelin E, Francois E, Conroy T, Raoul JL, Becouarn Y, Bertheault-Cvitkovic F, Ychou M, Nasca S, Fandi A, Barthelemy P, Douillard JY. Multicenter non-randomized phase II study of raltitrexed (Tomudex) and oxaliplatin in non-pretreated metastatic colorectal cancer patients. Ann Oncol. 2002 Jul;13(7):1072-9. doi: 10.1093/annonc/mdf183. PMID 12176786
- BACKGROUNDCascinu S, Graziano F, Ferrau F, Catalano V, Massacesi C, Santini D, Silva RR, Barni S, Zaniboni A, Battelli N, Siena S, Giordani P, Mari D, Baldelli AM, Antognoli S, Maisano R, Priolo D, Pessi MA, Tonini G, Rota S, Labianca R. Raltitrexed plus oxaliplatin (TOMOX) as first-line chemotherapy for metastatic colorectal cancer. A phase II study of the Italian Group for the Study of Gastrointestinal Tract Carcinomas (GISCAD). Ann Oncol. 2002 May;13(5):716-20. doi: 10.1093/annonc/mdf091. PMID 12075739