Preoperative Concurrent Chemoradiotherapy for Locally Advanced Gastroesophageal Junction or Upper Gastric Adenocarcinoma

Gastroesophageal Junction Adenocarcinoma Clinical Trial

Official title:

Phase Ⅱ/Ⅲ Study of Preoperative Concurrent Chemoradiotherapy for Locally Advanced Gastroesophageal Junction or Upper Gastric Adenocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02193594
• Other study ID #: CRADLE
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: July 8, 2014
• Last updated: June 4, 2015
• Start date: January 2014
• Est. completion date: May 2020

Study information

• Verified date: June 2015
• Source: Peking University
• Contact: Jiafu Ji, M.D.
• Email: jiafuj[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Preoperative chemoradiotherapy(CRT) had been introduced in the comprehensive treatment of gastroesophageal junction and upper gastric cancers in the decade.According to some researches,CRT had shown its good curative effects in local control and prolonged overall survival.However,the optimization scheme for CRT and its influence to surgery remains controversial.Meanwhile,there were many design flaws in the past few research,such as the lack of adjuvant chemotherapy,the insufficiency in lymphnodes dissection.We decided to carry out the trial,eliminating all the bias as far as we can,to illustrate the efficacy and safety of CRT.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 214
• Est. completion date: May 2020
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Histologically proven adenocarcinoma of the gastroesophageal junction.

• Clinical stage diagnosed by endoscopic ultrasound(EUS) or computed tomography(CT) as T3-4NxM0 tumors,according to American Joint Committee on Cancer (AJCC) 7th edition.

• Eastern Cooperative Oncology Group (ECOG) performance status=2.

• Informed consent obtained.

Exclusion Criteria:

• Combined with other malignant tumors.

• Eastern Cooperative Oncology Group (ECOG) performance status>2.

• Combined with severe organ dysfunction.

• Pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Neoplasms
• Gastroesophageal Junction Adenocarcinoma

Intervention

Radiation:
• Preoperative concurrent chemoradiotherapy
The patients will receive radiotherapy in the total amount of 50Gy(25 fractions) preoperatively,concurrently combined with chemotherapy,which consist of oxaliplatin 40mg/m2 administrated on days 1,8,15,22,29 and S-1® 30mg/m2 twice per day on days 1 to 5 per week.

Procedure:
• Radical D2 total gastrectomy
Within 5-6 weeks after the completion of neoadjuvant therapy,the patients in CCRT group will receive the radical total gastrectomy with D2 lymphadenectomy,and patients in the CT group will receive the surgery right after randomization.

Drug:
• Adjuvant chemotherapy
Within 2 months after surgery,the patients will receive chemotherapy for 6 to 8 cycles ,consist of oxaliplatin 130mg/m2 administrated on day1 and S-1® 40-60mg twice per day on days 1 to 14 per 3 weeks.The S-1® dosage depends on the patient BSA(BSA<1.25m2 40mg,1.25 m2=BSA=1.5 m2 50mg ,BSA>1.5 m2 60mg). Patients in the CCRT group will receive 6 cycles of chemotherapy and patients in the CT group will receive 8 cycles of chemotherapy.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Haidian District	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Peking University	Beijing Friendship Hospital, Chinese PLA General Hospital, Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The pathologic profiles and the pathologic response rates	the pathologic profiles and the pathologic response rates	Within 30 days after the day of operation	No
Primary	The patient's survival time and recurrence time	3-year overall survival; 1-year and 3-year recurrence free survival	Up to 3 years	No
Secondary	The number of patients with complications	the morbidity and mortality rates within 30 days after the day of operation	Within 30 days after the day of operation	Yes