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Preoperative Stomach Cancer Induction Chemotherapy and Radiation Therapy (President)

Primary Purpose

Locally Advanced Gastric Carcinoma

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Arm 1 pre-operative chemoradiation
Arm 2 post operative chemoradiation
Sponsored by
Sichuan Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Gastric Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with potentially resectable adenocarcinoma of the stomach with histologic proof.
  • EUS or MRI stage T3-4, any N, M0.
  • Adequate bone marrow (defined as peripheral absolute granulocyte count of > 2,000/μL, and platelet count of>100,000/μL), liver (bilirubin < 1.5 mg/dl), and renal functions (creatinine < 1.5 mg/dl).
  • Absence of peritoneal disease by laparoscopic staging; no positive cytology of pleural, or pericardial effusion.
  • No prior major surgery or radiotherapy to the stomach, or immunotherapy or chemotherapy for any reason.
  • Patients must have a life expectancy of at least 16 weeks.
  • Performance status of < 2 (Zubrod scale).
  • No biopsy proof of lymph node metastases outside the study field.
  • No evidence of metastatic disease to distant organs.
  • No presence of concurrent or previous malignancies < 5 years, other than noninvasive skin cancer.
  • No uncontrolled or severe cardiac disease, diabetes or hypertension.
  • Signed study-specific consent form prior to study entry.

Exclusion Criteria:

  • Evidence of metastatic disease
  • Prior chemotherapy or radiotherapy
  • Patients with a past history of cancer
  • Patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled
  • Pregnant or lactating females or female patients of childbearing potential who have not been surgically sterilized or are without adequate contraceptive measures
  • Cardiac failure or Sever Pulmonary disease
  • Patients with impaired gastrointestinal absorption for whatever reason
  • Patients medically unfit for cisplatin or taxol chemotherapy

Sites / Locations

  • Xijing Hospital, GI institute
  • friendship HospitalRecruiting
  • ziyang People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1 pre-operative chemoradiation

Arm 2 post operative chemoradiation

Arm Description

Chemo1 x 2 followed by ChemRT followed by Surgery followed by Chemo2 x 2

Surgery followed by Chemo1 x 2 followed by ChemRT followed by Chemo2 x 2

Outcomes

Primary Outcome Measures

Progression Free Survival

Secondary Outcome Measures

Overall Survival
R0 Resection Rate

Full Information

First Posted
July 18, 2017
Last Updated
August 16, 2017
Sponsor
Sichuan Provincial People's Hospital
Collaborators
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03223740
Brief Title
Preoperative Stomach Cancer Induction Chemotherapy and Radiation Therapy
Acronym
President
Official Title
A Phase III Trial of Preoperative or Postoperative Chemoradiation Therapy for Potentially Resectable Adenocarcinoma of Stomach Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sichuan Provincial People's Hospital
Collaborators
Xijing Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Based upon RTOG 9904, this study is to investigate the role of preoperative chemo and chemoradiation for locally advanced gastric cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Gastric Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 pre-operative chemoradiation
Arm Type
Experimental
Arm Description
Chemo1 x 2 followed by ChemRT followed by Surgery followed by Chemo2 x 2
Arm Title
Arm 2 post operative chemoradiation
Arm Type
Active Comparator
Arm Description
Surgery followed by Chemo1 x 2 followed by ChemRT followed by Chemo2 x 2
Intervention Type
Other
Intervention Name(s)
Arm 1 pre-operative chemoradiation
Intervention Description
Chemotherapy 1: First 2 courses of chemotherapy with the Capacitabine /cisplatin/ combination.Capacitabine1 g/me2 day 1 to 14. Cisplatin will be given at 20 mg/m2 as a one-hour bolus on day1-5. Chemoradiotherapy: At the end of the second 21 days of chemotherapy and one week of rest (day 57), a total of 45 Gy(1.8 Gyfx/d) of radiotherapy will be given with concurrent capacitabine 625 mg/m2 and weekly Taxol 45mg/m2 over 3 hours for 5 weeks. Chemotherapy2: Four to five weeks after chemoradiotherapy, Restaged and surgical resection, a D2 resection is encouraged. Peritoneal cytology will be obtained. The J-tube will be left in for at least 8 weeks after surgery to supplement patient's nutrition. 2nd courses of chemotherapy with the Capacitabine. Capacitabine1 g/me2 day 1 to 14. Chemotherapy will be repeated beginning on Day 29.
Intervention Type
Other
Intervention Name(s)
Arm 2 post operative chemoradiation
Intervention Description
Surgical resection, a D2 resection is encouraged. Chemotherapy 1: All patients will first receive two courses of chemotherapy with the Capacitabin /cisplatin/ combination.Capacitabine1 g/me2 day 1 to 14. Cisplatin will be given at 20 mg/m2 as a bolus on day1-5. Chemotherapywill be repeated beginning on Day 22. Chemoradiotherapy: At the end of the second 21 days of chemotherapy and one week of rest (day 57), a total of 45 Gy(1.8 Gyfx/d) of radiotherapy will be given with concurrent capacitabine 625 mg/m2 and weekly Taxol 45mg/m2 over 3 hours for 5 weeks. Chemotherapy2: 2nd courses of chemotherapy with the Capacitabin. Capacitabine 1g/me2 day 1 to 14. Chemotherapy will be repeated beginning on Day 29
Primary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
up to 5 year
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
up to 5 year
Title
R0 Resection Rate
Time Frame
At time of surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with potentially resectable adenocarcinoma of the stomach with histologic proof. EUS or MRI stage T3-4, any N, M0. Adequate bone marrow (defined as peripheral absolute granulocyte count of > 2,000/μL, and platelet count of>100,000/μL), liver (bilirubin < 1.5 mg/dl), and renal functions (creatinine < 1.5 mg/dl). Absence of peritoneal disease by laparoscopic staging; no positive cytology of pleural, or pericardial effusion. No prior major surgery or radiotherapy to the stomach, or immunotherapy or chemotherapy for any reason. Patients must have a life expectancy of at least 16 weeks. Performance status of < 2 (Zubrod scale). No biopsy proof of lymph node metastases outside the study field. No evidence of metastatic disease to distant organs. No presence of concurrent or previous malignancies < 5 years, other than noninvasive skin cancer. No uncontrolled or severe cardiac disease, diabetes or hypertension. Signed study-specific consent form prior to study entry. Exclusion Criteria: Evidence of metastatic disease Prior chemotherapy or radiotherapy Patients with a past history of cancer Patients with other significant underlying medical conditions that may be aggravated by the study treatment or are not controlled Pregnant or lactating females or female patients of childbearing potential who have not been surgically sterilized or are without adequate contraceptive measures Cardiac failure or Sever Pulmonary disease Patients with impaired gastrointestinal absorption for whatever reason Patients medically unfit for cisplatin or taxol chemotherapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qian Peng, MD PhD
Phone
008617708130617
Email
pengqian0522@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Zeng, MD PhD
Organizational Affiliation
Sichuan Academy of Medical Science
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hongwei Zhang, MD PhD
Organizational Affiliation
Xijing Hosptial, GI institute
Official's Role
Study Chair
Facility Information:
Facility Name
Xijing Hospital, GI institute
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Active, not recruiting
Facility Name
friendship Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
lili deng, MD
Phone
+8613880926676
Facility Name
ziyang People's Hospital
City
Siyang
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
min wei, MD
Phone
+8613980386078

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Preoperative Stomach Cancer Induction Chemotherapy and Radiation Therapy

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