Perioperative Chemoradiotherapy for Potentially Resectable Gastric Cancer

Stomach Neoplasms Clinical Trial

Official title:

Phase II Study of Preoperative Chemotherapy and Postoperative Chemo-Radiation for Newly Diagnosed, Potentially Resectable Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00420394
• Other study ID #: SOR446006ctil
• Status: Recruiting
• Phase: Phase 2
• First received: January 9, 2007
• Last updated: June 19, 2007
• Start date: April 2007

Study information

• Verified date: January 2007
• Source: Soroka University Medical Center
• Contact: Margarita Tokar, MD
• Phone: +972-8-6400768
• Email: Ritato[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Rationale: Adjuvant chemoradiation considered as standard of care after curative surgery for adenocarcinoma of stomach and gastroesophageal cancer. Preoperative chemotherapy in the in locally advanced gastric cancer results in significant tumoral downstaging with improved rate of curative resections.

Purpose: To evaluate feasibility and safety of combination of preoperative chemotherapy and postoperative chemoradiation for locally advanced adenocarcinoma of stomach and gastroesophageal cancer

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Histologically confirmed primary adenocarcinoma, poorly differentiated carcinoma, or carcinoma not otherwise specified, of stomach or gastro-esophageal junction.

2. T2-4 N0-3 M0. T1 tumors are eligible if T1N1-3

3. Disease must be clinically limited to the stomach or GEJ.

4. Pre-treatment Port-a-Cath insertion obligatory

5. No prior chemotherapy.

6. No prior radiotherapy.

7. Patients must be surgical candidates as determined by the treating surgeon.

8. Adequate organ function defined as:

9. Patients must have an ECOG Performance Status < 1.

10. Patients must be able to sign the informed consent document.

Exclusion Criteria:

1. Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy, endoscopic ultrasound and CT scanning.

2. Patients with primary carcinomas of the esophagus.

3. Prior chest or upper abdomen radiotherapy, prior systemic chemotherapy within the past 5 years, or prior esophageal or gastric surgery.

4. Patients with evidence of metastatic disease are not eligible.

5. New York Heart Association Class III or IV heart disease.

6. Severe co-morbid conditions or nonmalignant illness whose control may be jeopardized by complications of the study treatment.

7. Pregnant or lactating women or men unable or unwilling to practice contraception are excluded.

8. Any history of prior malignancy (other than non-melanoma skin cancer, in-situ cervical cancer, or superficial transitional cell bladder cancer).

9. Clinically significant hearing loss.

10. Patients with a history of seizure disorder who are receiving phenytoin, phenobarbital, or other antiepileptic medication.

11. Patients who cannot fully comprehend the therapeutic implications of the protocol or comply with its requirements.

12. Patients with any medical or psychiatric condition or disease which, in the investigator’s judgment, would make the patient inappropriate for entry into this study

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Procedure:
• Chemotherapy

• surgery

• radiotherapy

Locations

Country	Name	City	State
Israel	Soroka University Medical Center,Oncology Center	Beer-sheva

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the study regimen.
Secondary	Rate of R0 resection following chemotherapy.
Secondary	Morbidity and mortality of surgery following chemotherapy.
Secondary	Overall and progression free survival following the study treatment plan