Postoperative Sequence Chemoradiotherapy Compared With Chemotherapy Alone for Advanced Gastric Cancer

NCT01197118 | Unknown Phase 2

• 1 other identifier: TJCC-GC001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Cancer

Keywords

gastric cancer; sequence chemoradiotherapy; OLF regimen; survival rate

Outcome Measures

Primary Outcomes (1)

• overall survival

  1 year

Study Arms (2)

2

ACTIVE COMPARATOR

chemotherapy alone following radical resection

Drug: chemotherapy alone following radical resection

1

EXPERIMENTAL

sequence chemoradiotherapy following radical resection

Radiation: sequence chemoradiotherapy

Interventions

sequence chemoradiotherapy RADIATION

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

1

chemotherapy alone following radical resection DRUG

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.

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postoperative histologically confirmed advanced adenocarcinoma of the stomach or the gastroesophageal junction.
• Age of 18 to 75, Karnofsky score higher than 70.
• Postoperative histologically conformed metastasis in perigastric lymph nodes and/or tumor invasion to muscularis propria or subserosa, with or without positive incisal margin.
• No severe functional damage of major organ, normal blood cell, normal liver and kidney function.
• No clinical findings of distant metastasis.
• Predictive survival time longer than 6 months.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Tongji Cancer Center,Tongji Hospital

Wuhan, Hubei, 430030, China

Location

Related Publications (1)

• Xiang-Lin Yuan, Qiang Fu ,Shi-Ying Yu .Postoperative sequence chemoradiotherapy for advanced gastric cancer:an analysis of 36 cases.World Chinese Journal of Digestology,2007(36):3856-3859.

  BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Shiying Yu, Master

  Tongji Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiang Fu, Master

CONTACT

86-27-63089811; yunr777@yahoo.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 23, 2009
• First Posted: September 9, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: May 1, 2011
• Last Updated: September 9, 2010

Record last verified: 2010-09

Locations

CN (1)