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Trial Title:
Postoperative Sequence Chemoradiotherapy Compared With Chemotherapy Alone for Advanced Gastric Cancer
NCT ID:
NCT01197118
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
gastric cancer
sequence chemoradiotherapy
OLF regimen
survival rate
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
sequence chemoradiotherapy
Description:
Postoperative radiotherapy regimen: Therapy plan system was formulated by Computed
tomographic (CT) simulation. Radiation was delivered with 15MV photons. Radiotherapy
consisted of 4500 cGy of radiation at 180 cGy per day, five days per week for five weeks,
to the tumor bed, to the margins of resection or the stoma, to the regional nodes.
Protection of spinal cord, heart, liver and kidney should be considered.
Postoperative chemotherapy regimen: see arm 2
Arm group label:
1
Intervention type:
Drug
Intervention name:
chemotherapy alone following radical resection
Description:
Postoperative chemotherapy regimen: The OLF regimen was administrated: Oxaliplatin, 130
mg/m2/day on day1, i.v. 2 h; fluorouracil, 425 mg/m2/day on day1~5, i.v.; leucovorin, 200
mg/m2/day on day 1~5, i.v.; every 21 days repeated, for 6 cycles.
Arm group label:
2
Summary:
Gastric cancer is one of the most prevalent malignancies in China; the survival rate
remains poor despite potentially curative resections. Complete surgical resection is the
only potentially curative therapy available to patients with gastric cancer. However,
even after a complete resection with negative margins, many patients will experience
recurrence. In recent years, the radiation therapy in the carcinoma of the stomach
represents a new issue that should be addressed accompanying the development of radial
physics and radial biology, the clinical application of computed tomographic (CT)
simulation and digital reconstitution technique, especially the application of
3-dimensional conformal and intensity modulated radiation therapy. Radiation therapy plus
concurrent chemotherapy has been demonstrated to cause a significant improvement in
overall and disease-free survival according to Intergroup Trial 0116/SWOG 9008. So the
investigators designed the trial to see whether a postoperative sequence
chemoradiotherapy including oxaliplatin fluorouracil-based regimen can improve survival
for advanced gastric cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Postoperative histologically confirmed advanced adenocarcinoma of the stomach or the
gastroesophageal junction.
2. Age of 18 to 75, Karnofsky score higher than 70.
3. Postoperative histologically conformed metastasis in perigastric lymph nodes and/or
tumor invasion to muscularis propria or subserosa, with or without positive incisal
margin.
4. No severe functional damage of major organ, normal blood cell, normal liver and
kidney function.
5. No clinical findings of distant metastasis.
6. Predictive survival time longer than 6 months.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tongji Cancer Center,Tongji Hospital
Address:
City:
Wuhan
Zip:
430030
Country:
China
Contact:
Last name:
Qiang Fu, Master
Phone:
86-27-83663342
Email:
yunr777@yahoo.com.cn
Contact backup:
Last name:
Shiying Yu, Master
Phone:
86-27-83663342
Email:
syyu@tjh.tjmu.edu.cn
Investigator:
Last name:
Shiying Yu, Master
Email:
Principal Investigator
Investigator:
Last name:
Qiang Fu, Master
Email:
Sub-Investigator
Start date:
September 2010
Completion date:
May 2011
Lead sponsor:
Agency:
Huazhong University of Science and Technology
Agency class:
Other
Source:
Huazhong University of Science and Technology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01197118
