Postoperative Sequence Chemoradiotherapy Compared With Chemotherapy Alone for Advanced Gastric Cancer

Huazhong University of Science and Technology

Status and phase: Unknown; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: chemotherapy alone following radical resection; Radiation: sequence chemoradiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01197118

TJCC-GC001

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

2

Active Comparator group

Description:

chemotherapy alone following radical resection

Treatment:

Drug: chemotherapy alone following radical resection

1

Experimental group

Description:

sequence chemoradiotherapy following radical resection

Treatment:

Radiation: sequence chemoradiotherapy