Health Condition 1: C162- Malignant neoplasm of body of stomach Health Condition 2: C160- Malignant neoplasm of cardia Health Condition 3: C161- Malignant neoplasm of fundus of stomach Health Condition 4: C163- Malignant neoplasm of pyloric antrum Health Condition 5: C164- Malignant neoplasm of pylorus
Conditions
Interventions
Intervention1: Chemoradiotherapy will be given pre surgery followed by chemotherapy post surgery , when patient is eligible for the curative intent
palliative intent the chemotherapy will be continue
Sponsors
JIPMER
Eligibility
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed Adenocarcinoma, of the stomach or gastroesophageal junction [steiwert3], Stage 4b[Invasion of Adjacent structures] or bulky N2/N3 disease deemed inoperable by multidisplinary team[MDT] after staging with CECT or Pec-ct and D-laparoscopy.(inoperability criteria - involvement of adjacent organs like pancreas, liver, spleen etc, lesion encroaching duodenum, non regional lymph nodes like paraaortic nodes, involvement of bile duct, involvement of bile duct, common hepatic artery, celiac trunk 2.Age 18 to 70 3.ECOG 0-1
Exclusion criteria
Exclusion criteria: 1.Disease metastasis [M1] 2.Prior Chemotherapy or Radiotherapy for gastric cancer 3.Uncontrolled comorbidites [ cardiac ejection fraction less than 50 percent, severe COPD,s. Creatinine more than 1.6mg/dl] 4.Pregnancy or Breast Feeding 5.Contraindication to radiotherapy [prior abdominal radiation, connective tissue disorder]
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To asses the R0 [complete microscopic resection ]resection rate in patient with unresectable locally advanced gastric cancer in the setting of preoperative chemoradiotherapy [This will be check on the histopathology specimen retrieve post surgery]Timepoint: This will be checked postoperatively by histopathology within some 1-2 week of surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the Radiologiocal [after CTRT ] & pathological tumor response rate [post surgery] Timepoint: via RESCIST criteria within 2-3 weeks of preoperative chemoradiotherapy & Histopathological examination with 1-2 weeks of surgery respectively within;2. To assess treatment compliance & toxicity profileTimepoint: Patient will be assessed in weekly basis in OPD as they come of the next cycle & after completion of Chemotherapy & radiotherapy respectively in the respective OPD & in Surgery OPD in 4 weeks time period & will also be told to come in emergency if severe toxicity so developed SOS;3.To assess event free survival, [events are local and/or regional recurrence or progression ,distant recurrence or death from any causeTimepoint: it will be assessed in 6months & 1 year of respective sample collection | — |
Countries
India
Contacts
Public ContactAnandhi A
JIPMER
Outcome results
None listed