Clinical trial NCT03368131: Concurrent Neoadjuvant Chemoradiotherapy Plus Trastuzumab in the Treatment of Siewert II ，III of Human Epidermal Growth Factor Receptor-2(HER-2) Positive Gastroesophageal Junction Adenocarcinoma： A Randomized, Controlled Clinical Study
Official title: A Prospective Study of Concurrent Neoadjuvant Chemoradiotherapy Plus Trastuzumab for Siewert II ，III of HER-2 Positive Adenocarcinoma at Gastroesophageal Junction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastroesophageal Junction Adenocarcinoma
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2017-12-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of patients who receive concurrent neoadjuvant chemoradiotherapy for Siewert II ，III of locally advanced HER-2 Positive adenocarcinoma at gastroesophageal junction


Eligibility criteria: Inclusion Criteria:

* Age:18 to 60 years old (man or female);
* confirmed to Siewert II , III of locally advanced adenocarcinoma at gastroesophageal junction. The her-2 positive was detected by immunohistochemistry or Fluorescence in SituHybridization(FISH);
* Patients with Stage for Ⅲ by Endorectal Ultrasonography( EUS), Computed Tomography(CT) (or Positron Emission Tomography(PET )-CT) and laparoscopic (According to the eighth edition of American Joint Committee on Cancer (AJCC) );
* Patients are diagnosed as potentially resectable by multidisciplinary team, no surgical contraindications, and expected to be surgical resection;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
* Major organ function has to meet the following criteria:

HB≥80g/L; ANC≥1.5×109/L; PLT≥90×109/L; Alanine Transaminase (ALT) and Aspartate Transaminase(AST)≤2.5×ULN, but\<≤5×ULN if the transferase elevation is due to liver metastases； Total Bilirubin(TBIL)\<1.5×ULN； Serum creatinine ≤1.5×ULN;Serum albumin ≥ 30g / L

* Life expectancy greater than or equal to 6 months;
* Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.

Exclusion Criteria:

* Allergic to trastuzumab, capecitabine and oxaliplatin;
* severe diseases such as liver and kidney，myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia，which affect the situation of chemotherapy or surgery
* A variety of factors influencing oral drugs (such as unable to swallow, nausea, vomiting, chronic diarrhea and intestinal obstruction, etc);
* Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (+ +); Has melena and hematemesis in two months;
* Coagulant function abnormality (International Normalized Ratio(INR) \> 1.5 ULN, Activated Partial Thromboplastin Time(APTT ) \> 1.5 ULN), with bleeding tendency;
* Pregnant or lactating women;
* Patients with other malignant tumors within 5 years (except for curable skin basal cell carcinoma and cervical carcinoma in situ);
* History of psychiatric drugs abuse and can't quit or patients with mental disorders;
* Less than 4 weeks from the last clinical trial;
* The researchers think inappropriate.

Primary outcomes:
measure: The pathological complete response rate(pCR)
timeFrame: within 3 weeks after surgery
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 3 years
measure: Disease-free survival(DFS)
timeFrame: 3 years
measure: Disease Control Rate (DCR)
timeFrame: 3 years
measure: Percentage of Participants With Objective Response According to Modified Response Evaluation Criteria In Solid Tumors(mRECIST) v1.1
timeFrame: within 3 weeks after surgery
measure: Percentage of Participants With Clinically Significant Improvement in European Organisation for Research and Treatment of Cancer Quality of Life Core Module 30 (EORTC Quality of Life Questionnaire (QLQ)-C30) Score
timeFrame: Day 1 of each treatment cycle, at the study drug completion visit, and thereafter at follow-up
measure: Adverse events
timeFrame: 3 years
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Fourth Affiliated Hospital of Hebei Medical University
state: Hebei
Study officials:
affiliation: Hebei Medical University Fourth Hospital
name: Qun Zhao
role: PRINCIPAL_INVESTIGATOR
affiliation: Hebei Medical University Fourth Hospital
name: Jun Wang
role: PRINCIPAL_INVESTIGATOR
References: