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
| Registry | NCT03308552 |
|---|---|
| Status | Unknown |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 164 (Estimated) |
| Sponsor | Chinese Academy of Medical Sciences (Other); collaborators: Hebei Medical University Fourth Hospital, Tianjin Medical University Cancer Institute and Hospital, Anyang Tumor Hospital, The First Affiliated Hospital with Nanjing Medical University, Affiliated Hospital of Hebei University, Fujian Cancer Hospital, Sichuan Cancer Hospital and Research Institute |
| Conditions | Esophageal Neoplasms |
| Interventions | SIB-IMRT, Paclitaxel, Platinum-Based Drug (Radiation, drug) |
| Dates | start 2017-12-01, primary completion 2020-08-30 (estimated), completion 2021-08-30 (estimated), first posted 2017-10-12, last updated 2019-01-02 |
| Locations | 1 site in China |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| SIB-IMRT combined chemotherapy followed by chemotherapy | Active comparator | Radiation: SIB-IMRT; Drug: Paclitaxel; Drug: Platinum-Based Drug | 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. |
| SIB-IMRT Alone followed by chemotherapy | Placebo comparator | Radiation: SIB-IMRT; Drug: Paclitaxel; Drug: Platinum-Based Drug | 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. |
Sex: All, ages: 18 Years to 69 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Department of Radiation Oncology, Cancer Hospital, National Cancer Center, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) | Beijing, Beijing Municipality | China | Recruiting |