A Randomized Phase II Trial of Neoadjuvant Chemotherapy Compared With Chemoradiotherapy in Gastric Adenocarcinoma
Study Details
Study Description
Brief Summary
This prospective, randomized phase II study is designed to evaluate weather neoadjuvant chemoradiotherapy is superior to neoadjuvant chemotherapy with both followed by surgery and postoperative chemotherapy for locally advanced gastric adenocarcinoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Neoadjuvant Chemoradiotherapy (NCRT) NCRT arm receives intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) (45.1Gy and 40.04Gy in 22 fractions) concurrently with oral S-1(40mg/m2, orally twice daily every weekday) followed by surgery and four to six cycles of SOX at the same dosage with NCT arm. |
Radiation: SIB-IMRT
45.1Gy and 40.04Gy in 22 fractions using intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) to primary tumor
Drug: S-1
40mg/m2, orally twice daily every weekday concurrently with radiotherapy treatment
Other Names:
Procedure: Surgery
Surgery, preferred D2 lymphadenectomy
Drug: SOX
SOX (S-1: 40~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle)
Other Names:
|
| Active Comparator: Neoadjuvant Chemotherapy (NCT) NCT arm consists of neoadjuvant three cycles of SOX(S-1: 40~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle followed by radical surgery and another postoperative three cycles of SOX. |
Procedure: Surgery
Surgery, preferred D2 lymphadenectomy
Drug: SOX
SOX (S-1: 40~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle)
Other Names:
|
Outcome Measures
Primary Outcome Measures
- R0 resection rate [2-3 months]
The surgical procedure was total or subtotal gastrectomy with recommended D2 lymphadenectomy 4-6 weeks after neoadjuvant therapy.
Secondary Outcome Measures
- Pathological response rate [2-3 months]
Pathological response were classified into three grades.Grade I signifies that there is little shrinkage in the tumor; only mild regression in the tumor cells is observed under themicroscope. Grade II shows gross reduction in size of the tumor and marked regression in the cancer cells microscopically, yet viable nests of cancer tissue are still visible. Grade III implies complete or almost total resolution of the tumor on exploration, and disappearance of the tumor tissue microscopically; only remnants of degenerated cancer cells can be seen (so-called ghost cancer cells).
- Tumor down-staging [2-3 months]
Down-staging was considered as any stage reduction between clinical and pathologic stage.
- Postoperative complications [2-3 months]
During hospital stay and within the first 30 days after completion of surgery.
- Acute chemotherapy/Chemoradiotherapy toxicities [6-8 months]
chemotherapy toxicities are evaluated by NCI-CTC version 4.0 and radiotherapy toxicities are graded using the RTOG/EORTC Radiation Morbidity Scoring Schema.
- Distant metastasis free survival [3 years]
- Locoregional recurrence free survival [3 years]
- Overall survival [3 years]
Other Outcome Measures
- Comparison of dosimetric differences between radiation techniques [1 year]
To compare the dosimetric differences between the volumetric-modulated arc therapy (VMAT), Tomotherapy and intensity-modulated radiotherapy (IMRT) techniques in treatment planning.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Histologically or cytologically proven locally advanced gastric adenocarcinoma in patients staged as cT3-4N0M0 or anyTN+M0
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No distant metastasis in liver,lung,bone,central nervous system(CNS),no peritoneal transplantation
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No prior abdominal or pelvic radiotherapy
-
Karnofsky performance status(KPS)≥ 70, predictive life span no less than 6 months
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Patients must have normal organ and marrow function as defined below: Leukocytes: greater than or equal to 3,000 G/L; Platelets: greater than or equal to 100,000/mm3 .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit; Creatinine within normal upper limits
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Informed consent
Exclusion Criteria:
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Any prior chemotherapy or other cancer treatment prior to this protocol
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Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer
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With any distant metastasis in liver,lung,bone,CNS,or peritoneal transplantation
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History of allergic reactions attributed to similar chemical or biologic complex to S-1 or Xeloda or Oxaliplatin
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Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
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History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
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History of prior radiation to the abdomen
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Pregnant or lactating females
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) | Beijing | China | 100021 |
Sponsors and Collaborators
- Chinese Academy of Medical Sciences
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCC2015ST-09