| CTRI Number |
CTRI/2013/05/003708 [Registered on: 30/05/2013] Trial Registered Retrospectively |
| Last Modified On: |
15/05/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Trial comparing surgery first or chemotherapy first in stomach cancer |
|
Scientific Title of Study
|
Randomized controlled trial of perioperative versus postoperative chemotherapy in resectable carcinoma stomach |
| Trial Acronym |
SIOG-STO-1 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr E Hemanth Raj |
| Designation |
Chairman, Division of Surgical Oncology |
| Affiliation |
Cancer Institute (WIA) |
| Address |
Dr.S.Krishnamurti Campus, No.18, Sardar Patel Road, Guindy, Chennai
Chennai
TAMIL NADU
600036
India |
| Phone |
9840014505 |
| Fax |
91-44-24912085 |
| Email |
ehemanthraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramakrishnan A S |
| Designation |
Additional Professor, Division of Surgical Oncology |
| Affiliation |
Cancer Institute (WIA) |
| Address |
Dr.S.Krishnamurti Campus, No.18, Sardar Patel Road, Guindy, Chennai
Chennai
TAMIL NADU
600036
India |
| Phone |
9840085569 |
| Fax |
91-44-24912085 |
| Email |
ram_a_s@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramakrishnan A S |
| Designation |
Additional Professor, Division of Surgical Oncology |
| Affiliation |
Cancer Institute (WIA) |
| Address |
Dr.S.Krishnamurti Campus, No.18, Sardar Patel Road, Guindy, Chennai
Chennai
TAMIL NADU
600036
India |
| Phone |
9840085569 |
| Fax |
91-44-24912085 |
| Email |
ram_a_s@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Basavatarakam Indo-American Cancer Hospital and Research Institute,Road no.14, Banjara Hills,Hyderabad-500034 |
| Cancer Institute (WIA)
Dr.S.Krishnamurti Campus,
No.18, Sardar Patel road, Guindy, Chennai-600036 |
| Christian Medical College and Hospital, Dr.Ida Scudder Road, Vellore |
| Kidwai Memorial Institute of Oncology,Dr.M H Marigowda road, Bangalore-560029 |
| MNJ Institute of Oncology and Regional Cancer Center,Red Hills, Hyderabad-500004 |
|
|
Primary Sponsor
|
| Name |
South Indian Oncology Group |
| Address |
Cancer Institute (WIA), Dr.S.Krishnamurti Campus,
No.18, Sardar Patel road, Guindy, Chennai-600036 |
| Type of Sponsor |
Other [Multicenter co-operative cancer research organisation] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrT Subramanyeshwar Rao |
Basavatarakam Indo-American Cancer Hospital and Research Institute |
Road no.14,Banjara Hills, Hyderabad-500034
Hyderabad
ANDHRA PRADESH |
9848038716
91-40-23542120
subramanyeswar@yahoo.com |
| DrRamakrishnan A S |
Cancer Institute (WIA) |
Division of Surgical Oncology, Dr.S.Krishnamurti Campus, No.18, Sardar Patel road, Guindy, Chennai-600036
Chennai
TAMIL NADU |
9840085569
91-44-24912085
ram_a_s@yahoo.com |
| Dr Raju Titus Chacko |
Christian Medical College Hospital |
Ida Scudder road, Vellore-632004
Vellore
TAMIL NADU |
9363250124
91-416-2232025
rchacko@cmcvellore.ac.in |
| Dr M Vijaykumar |
Kidwai Memorial Institute of Oncology |
Dr.M H Marigowda road, Bangalore-560029
Bangalore
KARNATAKA |
9448467765
91-80-26560723
mvijai2002@yahoo.com |
| DrMukta Srinivasulu |
MNJ Institute of Oncology and Regional Cancer Center |
Red Hills, Hyderabad-500004
Hyderabad
ANDHRA PRADESH |
9849044816
91-40-23314063
muktasrinivasulu@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Cancer Institute Ethical Committee |
Approved |
| Institutional Ethics Committee, Basavatarakam Indo-American Cancer Hospital and Research Institute, Hyderabad |
Approved |
| Institutional Ethics Committee, MNJ Institute of Oncology & Regional Cancer Center, Hyderabad |
Approved |
| Institutional Review Board, Christian Medical College, Vellore |
Approved |
| Medical Ethics Committee, Kidwai Memorial Institute of Oncology, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Carcinoma stomach (gastric cancer), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Adjuvant chemotherapy |
6 cycles of chemotherapy is given after completion of surgery |
| Intervention |
Perioperative chemotherapy |
2 cycles of chemotherapy is given initially followed by surgery and then 4 more cycles of chemotherapy is given after completion of surgery |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
•Histologically proven adenocarcinoma of the stomach or Siewert type 3 adenocarcinoma of the gastroesophageal junction stage T2-4 Nx or Tx N+.
•Resectable disease
•No distant metastasis, including peritoneal carcinomatosis
• No gastric outlet obstruction or uncontrolled bleeding
•CT scan and diagnostic laparoscopy are mandatory
•No prior therapy for the diagnosed gastric cancer
Patient characteristics:
•Age- 20 to 69 years
•ECOG performance status 0-2
Hemopoetic-
WBC > 4000/ cu. mm
Absolute neutrophil count > 2000/cu.mm
Platelet count > 100,000/ cu.mm
Hepatic- bilirubin not more than 1.5 times upper limit of nomal, AST & ALT not more than 1.5 times upper limit of normal
Renal- Creatinine not more than 1.25 times ULN, creatinine clearance > 60 ml/min
Cardiovascular-no prior arrhythmias, no prior congestive cardiac failure, no myocardial infarction within past 6 months, no unstable cardiac disease requiring treatment, Ejection fraction >50% on echo
Pulmonary- no evidence of severe obstructive or restrictive airway disease on pulmonary function tests.
|
|
| ExclusionCriteria |
| Details |
•Not pregnant or nursing
•Fertile patients must use effective contraception
•No other prior or concurrent neoplasm except adequately treated carcinoma in situ of cervix or basal cell carcinoma of skin
•No active infection
•No allergy to protocol drugs
•No history of significant neurologic or psychiatric disorders
•No other serious medical condition that would prevent compliance
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare overall survival and disease free survival in patients with locally advanced resectable gastric cancer treated with either perioperative or only postoperative chemotherapy |
Overall and disease-free survival will be analysed at 3 years and 5 years after completion of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Evaluate toxicity of and disease response to neoadjuvant chemotherapy
2. Evaluate the postoperative complications following neoadjuvant chemotherapy
3. Compare the curative resection rates in patients treated with these regimens.
4. Evaluate and compare quality of life in these patients before and after surgery
5. Include molecular/ biomarkers to assess response to neoadjuvant therapy
|
Post-treatment |
|
|
Target Sample Size
|
Total Sample Size="350"
Sample Size from India="350"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/02/2011 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Purpose of study: To conduct a randomized, open label phase III trial of perioperative versus postoperative chemotherapy in patients with resectable gastric cancer.
Primary objective: To compare overall survival and disease free survival in patients with locally advanced resectable gastric cancer treated with either perioperative or only postoperative chemotherapy
Hypothesis: The results of treatment of gastric cancer depend on the stage of the disease. Although early gastric cancer has a high curability rate, patients with advanced stage gastric cancer do not fare well even after complete surgical resection. The risk of recurrence increases as the disease stage increases. The failure after surgery with adequate lymphadenectomy is usually distant- either in the peritoneum or the liver, and only systemic chemotherapy can control micrometastatic disease. Also, in advanced stage gastric cancers, it may not be possible always to achieve an R0 resection due to the local/ regional extent of the disease. Adjuvant chemotherapy has not been shown to improve survival in most randomized controlled trials. The morbidity of surgery may also limit the ability to deliver postoperative chemotherapy effectively. Therefore, there is a lot of interest nowadays in neoadjuvant or preoperative chemotherapy.
Neoadjuvant chemotherapy has many theoretical advantages- it can treat micrometastatic disease at the earliest opportunity and it may downstage the tumor allowing complete resection. Neoadjuvant treatment in gastric cancer offers an opportunity to deliver systemic treatment when the patient is best able to tolerate it, since initiating postoperative chemotherapy is usually delayed following gastric cancer surgery.
|