Clinical trial · Interventional
Concurrent Chemoradiotherapy Containing Paclitaxel&Cisplatin With/Without Tarceva in Locally Advanced Esophageal Cancer
Concurrent Chemoradiotherapy Containing Paclitaxel and Cisplatin With/Without Tarceva in Locally Advanced Esophageal Carcinoma: a Randomized Phase III Multi-center Trial.
NCT00686114CI-TRIAL-00014367unknownPhase 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 study is multi-center randomized phase III one to evaluate the difference in local-control and survival rate between patients receiving concurrent chemoradiotherapy combined Tarceva or not.
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 Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
| Tarceva | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- A
- description
- Enlarged field + Paclitaxel + Cisplatin + Tarceva
- interventionNames
- Drug: Paclitaxel
- Drug: Cisplatin
- Drug: Tarceva
- Radiation: Radiotherapy
- type
- EXPERIMENTAL
- label
- B
- description
- Enlarged field + Paclitaxel + Cisplatin
- interventionNames
- Drug: Paclitaxel
- Drug: Cisplatin
- Radiation: Radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- C
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects must be confirmed Esophageal Carcinoma pathologically 2. (EUS)I~IVa, without contraindication for radical radiotherapy 3. Subjects haven't been given neither radiotherapy nor chemotherapy before 4. Age 18-70,behavioral status evaluation ECOG scores 0-2 and anticipated survival more than 6 months 5. In 7 days after being selected, subjects should follow the status: WBC ≥ 4.0 x 10\^9/L; ANC ≥ 1.5x 10\^9/L; PLT ≥ 100 x 10\^9/L; Hb ≥ 90 g/L; serum Cr ≤ ULN; serum bilirubin ≤ 1.5 ULN; ALT/AST ≤ 1.5 ULN 6. Subjects should sign for the informed consent 7. Subjects should perform good compliance 8. Male and female subjects who have the ability of fertility should take contraception during the whole course and also 3 months after last dosage.In 7 days before the inclusion, urine pregnancy tests of subjects should be negative. Exclusion Criteria: 1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy or targeted therapy 2. Complete obstruction of the esophagus, or patients who have the potential to develop perforation 3. Patients with a history of malignancy (except that skin carcinomas or in situ breast cancer, oral cancer and cervical cancer with expected survival ≥2 years 4. Patients who multiple foci esophagus 5. Patients who are/were given any other medicine tests currently/in last 4 weeks 6. Experienced hypersensitiveness with similar medicine or other kinds of bio-medicines 7. Women in status of pregnancy 8. Patients who have complications exist as following: (1)Uncontrolled angina and heart failure, have a history of hospitalization in 3 months; (2)A history of myocardial infarction in the past 6 months; (3)There is a need for antibiotic treatment of acute bacterial or fungal infection; (4)Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization; (5)Drug addiction, alcoholism and AIDS disease or long-term virus carriers; (6)Uncontrollable seizures, or loss of insight because of mental illness
References
Publications (1)
- DERIVEDXie C, Jing Z, Luo H, Jiang W, Ma L, Hu W, Zheng A, Li D, Ding L, Zhang H, Xie C, Lian X, Du D, Chen M, Bian X, Tan B, Xia B, Xie R, Liu Q, Wang L, Wu S. Chemoradiotherapy with extended nodal irradiation and/or erlotinib in locally advanced oesophageal squamous cell cancer: long-term update of a randomised phase 3 trial. Br J Cancer. 2020 Nov;123(11):1616-1624. doi: 10.1038/s41416-020-01054-6. Epub 2020 Sep 22. PMID 32958820