Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this phase II trial was to evaluate the feasibility, efficacy and tolerability of intensity-modulated radiotherapy combined with S-1 based chemotherapy in patients with pathologically positive lymph node after completely resected gastric cancer. Furthermore, the investigators sought to compare the dosimetric differences between the volumetric-modulated arc therapy (VMAT), Tomotherapy and intensity-modulated radiotherapy (IMRT) techniques in treatment planning for gastric cancer as adjuvant radiotherapy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S-1 based chemoradiotherapy | Experimental | S-1,80mg/m2/d,peroral BID,in treatment days concurrently with intensity-modulated radiotherapy in a standard manner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intensity-modulated radiotherapy | Radiation | A total irradiation dose of 45 Gy was delivered in daily 1.8-Gy fractions (5 days a week over 5 weeks) to all patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | 3 years | |
| Locoregional recurrence free survival | 3 years | |
| Overall survival | 3 years | |
| Distant metastasis free survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Chemoradiotherapy-induced toxicities assessed by CTCAE 4.0 | during treatment and within the first 30 days after completion of chemoradiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of dosimetric differences between radiation techniques | To compare the dosimetric differences between the volumetric-modulated arc therapy (VMAT), Tomotherapy and intensity-modulated radiotherapy (IMRT) techniques in treatment planning. | 1 year |
Inclusion Criteria:
Pathologically proven positive lymph node gastric adenocarcinoma in patients undergoing R0 resection
Any prior chemotherapy is allowed in this protocol
No distant metastasis in liver,lung,,bone,central nervous system(CNS),no peritoneal transplantation
No prior abdominal or pelvic radiotherapy
Karnofsky performance status(KPS)≥ 70, predictive life span no less than 6 months
Patients must have normal organ and marrow function as defined below:
Informed consent
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Jin, MD | Contact | +8613601365130 | jingjin1025@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) | Recruiting | Beijing | 100021 | China |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 22, 2016 | |
| Reset | Jan 19, 2017 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 22, 2016 | Jan 19, 2017 |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| C079198 | S 1 (combination) |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| S-1 | Drug | S-1,80mg/m2/d,peroral BID,in treatment days concurrently with intensity-modulated radiotherapy. |
|
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |