Clinical trial NCT01381913: Feasibility Trial of Neoadjuvant Chemoradiotherapy for Locally Advanced Gastric Cancer
Official title: Feasibility Trial of Neoadjuvant Chemoradiotherapy in Patients With Locally Advanced Gastric Cancer Combined With Adjacent Tissue Invasion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Chemoradiation
Keywords: Gastric cancer
Chemoradiotherapy
Adjacent tissue invasion
Feasibility trial
Lead sponsor: Kagawa University
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Histologically proven gastric adenocarcinoma
* Tumor invasion of adjacent structures (T4) and/or tumors with bulky nodal metastases

Brief summary: Because locally far-advanced gastric cancer combined with adjacent tissue invasion has a poor prognosis, some phase 2 and 3 clinical trials of neoadjuvant chemotherapy (NAC) are performed in Japan. However, neoadjuvant chemoradiotherapy (NACRT) achieves superior local tumor control compared with NAC. This feasibility trial explored the feasibility and safety of neoadjuvant chemoradiotherapy (NACRT) in this type of gastric cancer.

Detailed description: Since S-1 (combined drug of tegafur, 5-chloro-2,4-dihydroxypyridine and potassium oxonate) was approved in Japan in 1999 after a large-scale clinical trial, adjuvant chemotherapy with S-1 has been the standard treatment for stage II/III gastric cancer. However, for far-advanced gastric cancer, various adjuvant chemotherapies, including S-1, have not achieved satisfactory results. Therefore, Japan Clinical Oncology Group (JCOG) is currently performing phase 2 and 3 clinical trials of neoadjuvant chemotherapy (NAC) for locally far-advanced gastric cancer. However, previous studies of NAC have reported a pathological response rate of 15-50% for the main lesion, indicating no significant effect on local tumor control.

On the other hand, other studies have reported that anticancer drugs, including S-1, have a radiosensitizing effect, and that neoadjuvant chemoradiotherapy (NACRT) achieves superior local tumor control compared with NAC. Therefore, we conducted a feasibility trial of NACRT with S-1 for locally far-advanced gastric cancer combined with adjacent tissue invasion.

Eligibility criteria: Inclusion Criteria:

* Histologically proven gastric adenocarcinoma
* Tumor invasion of adjacent structures (T4) and/or tumors with bulky nodal metastases
* No metastases outside of Group 2 lymph nodes
* Neither peritoneal metastasis nor liver metastasis
* No other distant metastasis
* An Eastern cooperative oncology group performance status of between 0 and 2
* No prior radiation therapy
* Sufficient organ function

Exclusion Criteria:

* A synchronous or previously active malignancy
* Insufficient oral intake
* A history of severe allergy
* Watery diarrhea
* Severe co-morbidities
* Requiring therapy for pericardial effusion or pleural effusion
* Contraindications to S-1 or radiotherapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kita
country: Japan
facility: Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University
state: Kagawa
Study officials:
affiliation: Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University, Kagawa, Japan
name: Shinichi Yachida, M. D. Ph. D.
role: STUDY_DIRECTOR
affiliation: Department of Gastroenterological Surgery, Faculty of Medicine, Kagawa University, Kagawa, Japan
name: Yasuyuki Suzuki, M. D. Ph. D.
role: PRINCIPAL_INVESTIGATOR
References: