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

Peking University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Gastroesophageal Junction Adenocarcinoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02193594

CRADLE

Details and patient eligibility

About

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.

Enrollment: 214 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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214 participants in 2 patient groups

CCRT group

Experimental group

Description:

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.

Treatment:

Procedure: Radical D2 total gastrectomy

Radiation: Preoperative concurrent chemoradiotherapy

Drug: Adjuvant chemotherapy

CT group

Active Comparator group

Description:

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

Treatment:

Procedure: Radical D2 total gastrectomy

Drug: Adjuvant chemotherapy