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

NCT02193594 | Unknown Phase 2 DMC

• 1 other identifier: CRADLE
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastroesophageal Junction Adenocarcinoma

Keywords

Preoperative concurrent chemoradiotherapy; Neoadjuvant chemoradiotherapy; Gastroesophageal junction adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• The patient's survival time and recurrence time

  3-year overall survival 1-year and 3-year recurrence free survival

  Up to 3 years

Secondary Outcomes (1)

• The number of patients with complications

  Within 30 days after the day of operation

Other Outcomes (1)

• The pathologic profiles and the pathologic response rates

  Within 30 days after the day of operation

Study Arms (2)

CCRT group

EXPERIMENTAL

The patient in CCRT group will receive the preoperative concurrent chemoradiotherapy for 5 weeks and sequential radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 6 cycles.

Radiation: Preoperative concurrent chemoradiotherapy; Procedure: Radical D2 total gastrectomy; Drug: Adjuvant chemotherapy

CT group

ACTIVE COMPARATOR

The patient in CT group will receive radical D2 total gastrectomy and postoperative adjuvant chemotherapy of 8 cycles.

Procedure: Radical D2 total gastrectomy; Drug: Adjuvant chemotherapy

Interventions

Preoperative concurrent chemoradiotherapy RADIATION

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.

Also known as: CCRT, Eloxatin®, S-1®

CCRT group

Radical D2 total gastrectomy PROCEDURE

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.

CCRT group; CT group

Adjuvant chemotherapy DRUG

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.

Also known as: Eloxatin®, S-1®

CCRT group; CT group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Combined with other malignant tumors.
• Eastern Cooperative Oncology Group (ECOG) performance status\>2.
• Combined with severe organ dysfunction.
• Pregnancy

Sponsors & Collaborators

• Peking University: lead
• Chinese PLA General Hospital: collaborator
• Peking University People's Hospital: collaborator
• Beijing Friendship Hospital: collaborator

Study Sites (1)

Beijing Cancer Hospital

Haidian District, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Interventions

Oxaliplatin; S 1 (combination); Chemotherapy, Adjuvant

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Jiafu Ji, M.D.

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiafu Ji, M.D.

CONTACT

jiafuj@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Beijing Cancer Hospital,Director of Key Laboratory of Carcinogenesis and Translational Research(Gastric Cancer Laboratory)

Study Record Dates

• First Submitted: July 8, 2014
• First Posted: July 17, 2014
• Study Start: January 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: May 1, 2020
• Last Updated: June 8, 2015

Record last verified: 2015-06

Locations

CN (1)