Gastric Cancer
Conditions
Keywords
shared decision making, neoadjuvant chemotherapy, cycle, MRI, clinical response
Brief summary
The purpose of the study is to evaluate the maximal cycle of effective neoadjuvant chemotherapy for resectable gastric cancer, to determine what is the best cycle of neoadjuvant chemotherapy for the patients who receive neoadjuvant chemotherapy.
Detailed description
The study is a non-randomized clinical trial. The protocol has been approved by the Ethics Committee of Beijing Cancer Hospital. MRI and enhanced CT are used to evaluate the clinical response of the tumor. The primary endpoint is the maximal cycle of effective neoadjuvant chemotherapy for resectable gastric cancer.
Interventions
DRUGNACT
SOX: Oxaliplatin 130mg/m2,iv.,d1; S-1 60mg,po.,Bid,d1-14; Repeat every 21 days for n courses.(0\<n\<8)
PROCEDURESDM
Making the decision about the cycle of neoadjuvant chemotherapy with shared decision making
PROCEDURESurgery
Radical surgery with D2 lymph node dissection
DRUGACT
SOX: Oxaliplatin 130mg/m2,iv.,d1; S-1 60mg,po.,Bid,d1-14; Repeat every 21 days for 8-n courses.(0\<n\<8)
OTHERQuestionnaire
MAPPIN'SDM questionnaire, the control performance card, the care questionnaire, the decisional conflict questionnaire, the decisional regret questionnaire, the questionnaire of the reason for stopping neoadjuvant chemotherapy
Sponsors
Peking University
Study design
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Histologically proven adenocarcinoma of the stomach 2. Clinical cT2N+M0,or cT3-4a/N+M0 disease, confirmed by upper gastrointestinal endoscopy and abdominal computed tomography (CT) and MRI and laparoscopy. 3. Receive neoadjuvant chemotherapy in clinical
Exclusion criteria
1. Contraindication for chemotherapy 2. Contraindication for surgery 3. Clinically apparent distant metastasis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The cycle of neoadjuvant chemotherapy | 18months | The cycle of neoadjuvant chemotherapy means the maximal cycle of effective neoadjuvant chemotherapy. The effective means no disease progress by image diagnosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The completion rate of perioperative chemotherapy | 18 months | The completion rate of perioperative chemotherapy means the patient completed the 8 cycles of perioperative chemotherapy as planned (n cycles of neoadjuvant chemotherapy and 8-n cycles of adjuvant chemotherapy) |
| The progressive disease rate | 18 months | The progressive disease during neoadjuvant chemotherapy with shared decision making is is evaluated by CT/MRI according to the Response Evaluation Criteria In Solid Tumors (RECIST)1.1 |
| The pathological response | 18 months | The pathological response during neoadjuvant chemotherapy with shared decision making is evaluated according to the tumor regression grade of NCCN guideline. |
| The pathological complete response | 18months | The pathological complete response is defined as ypT0N0M0 |
| The adverse event of chemotherapy | 18 months | The adverse event of chemotherapy is evaluated and recorded according to the Common Terminology Criteria for Adverse Events (CTCAE) v.3 |
| The clinical response rate | 18 months | The clinical response is evaluated by CT/MRI according to the Response Evaluation Criteria In Solid Tumors (RECIST)1.1 |
| The 3-year progression-free survival | 48months | In terms of locally advanced gastric cancer, to evaluate the progression-free survival rate in gastrectomy with D2 lymph node dissection at postoperative 3 years |
| The cTNM,ycTNM,ypTNM stage | 60months | The cTNM stage, ycTNM stage and ypTNM stage is defined according to the 8th TNM stage. |
| The decisional conflicts | 12months | The decisional conflicts is evaluated by Decisional Conflict Scale |
| The decisional regrets | 12months | The decisional regrets is evaluated by Decision Regret Scale |
| The involvement of patients during the shared decision making | 12months | The involvement of patients during the shared decision making is evaluated by MAPPIN'SDM questionnaire |
| Surgical morbidity | 18 months | Surgical morbidity is defined as the events which occurs with-in postoperative 30 days, extension of hospitalization and re-hospitalization. It is necessary to evaluate the complication and if it occurs during the hospitalization, it is required to record complication name, date of on-set (postoperatively), grade on Clavien-Dindo Classification and treatment for complication. |
Countries
China
Contacts
Primary ContactZiyu Li, MD
Backup ContactYinkui Wang, MD
Outcome results
None listed