Clinical trial · Interventional
Radiotherapy With or Without Concurrent Chemotherapy for Limited Lymphatic Metastasis of Esophageal Cancer - 3JECROG P-02
A Randomized Phase III Study of Simultaneous Integrated Boost Intensity Modulated Radiation Therapy (SIB-IMRT) With or Without Concurrent Chemotherapy Followed by Consolidation Chemotherapy for Limited Lymphatic Metastasis of Esophageal Cancer - 3JECROG-P02
NCT03308552CI-TRIAL-00036314unknownPhase 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 designed to explore a higher radiation dose by using IMRT simultaneous integrated boost technique with or without concurrent chemotherapy for esophageal carcinoma with limited lymph node metastasis.
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 Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Platinum-Based Drug | Drug | — | UNRESOLVED |
| SIB-IMRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- SIB-IMRT combined chemotherapy followed by chemotherapy
- description
- SIB-IMRT: Patients receive radiotherapy once daily, 5 days a week for an average of 5.5 weeks. Radiotherapy is delivered to achieve a prophylactic dosage of 50.4Gy to PTV and 59.92Gy to PGTV in 28 fractions, respectively. Concurrent chemotherapy: Paclitaxel and platinum based drug are administered once a week for at least 5 weeks during radiotherapy treatment days.
- interventionNames
- Radiation: SIB-IMRT
- Drug: Paclitaxel
- Drug: Platinum-Based Drug
- type
- PLACEBO_COMPARATOR
- label
- SIB-IMRT Alone followed by chemotherapy
- description
- SIB-IMRT: Patients receive radiotherapy once daily, 5 days a week for an average of 5.5 weeks. Radiotherapy is delivered to achieve a prophylactic dosage of 50.4Gy to PTV and 59.92Gy to PGTV in 28 fractions, respectively.
- interventionNames
- Radiation: SIB-IMRT
- Drug: Paclitaxel
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 69 Years
Show eligibility criteria text
Inclusion Criteria: * Age\<70 * Diagnosis of clinical stage T2-4N0-1M1（According to UICC 2002） * A untreated squamous esophageal carcinoma * Karnofsky performance status(KPS)≥ 70 and Charlson score ≤3 * Adequate organ function * No known history of drug allergy * Blood routine examination : WBC≥4.0 * hepatic and renal function are normal Exclusion Criteria: * Age≥ 70 or \< 18 * Already received the treatment of chemotherapy or radiotherapy * Pregnant or lactating females * Known drug allergy * Without agreement of informed consent form * Insufficient hepatorenal function or Blood routine examination * Severe cardiovascular diseases, diabetes with uncontrolled blood sugar, mental disorders, uncontrolled severe infection, active ulceration which need intervention.
References
Publications (1)
- DERIVEDGao LR, Wang X, Han W, Deng W, Li C, Wang X, Zhao Y, Ni W, Chang X, Zhou Z, Deng L, Wang W, Liu W, Liang J, Zhang T, Bi N, Wang J, Zhai Y, Feng Q, Lv J, Li L, Xiao Z. A multicenter prospective phase III clinical randomized study of simultaneous integrated boost intensity-modulated radiotherapy with or without concurrent chemotherapy in patients with esophageal cancer: 3JECROG P-02 study protocol. BMC Cancer. 2020 Sep 22;20(1):901. doi: 10.1186/s12885-020-07387-y. PMID 32962674