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Preoperative Stomach Cancer Induction Chemotherapy and Radiation Therapy (President)

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ClinicalTrials.gov Identifier: NCT03223740
Recruitment Status : Recruiting
First Posted : July 21, 2017
Last Update Posted : August 21, 2017
Sponsor:
Collaborator:
Xijing Hospital
Information provided by (Responsible Party):
ming zeng, MD, Sichuan Provincial People's Hospital

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

Condition or disease Intervention/treatment Phase
Locally Advanced Gastric Carcinoma Other: Arm 1 pre-operative chemoradiation Other: Arm 2 post operative chemoradiation Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Trial of Preoperative or Postoperative Chemoradiation Therapy for Potentially Resectable Adenocarcinoma of Stomach Cancer
Study Start Date : September 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Arm 1 pre-operative chemoradiation
Chemo1 x 2 followed by ChemRT followed by Surgery followed by Chemo2 x 2
Other: Arm 1 pre-operative chemoradiation

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.


Active Comparator: Arm 2 post operative chemoradiation
Surgery followed by Chemo1 x 2 followed by ChemRT followed by Chemo2 x 2
Other: Arm 2 post operative chemoradiation

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 Measures :
  1. Progression Free Survival [ Time Frame: up to 5 year ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: up to 5 year ]
  2. R0 Resection Rate [ Time Frame: At time of surgery ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03223740


Contacts
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Contact: Qian Peng, MD PhD 008617708130617 pengqian0522@163.com

Locations
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China, Shanxi
Xijing Hospital, GI institute Active, not recruiting
Xi'an, Shanxi, China, 710032
China, Sichuan
friendship Hospital Recruiting
Chengdu, Sichuan, China, 610000
Contact: lili deng, MD    +8613880926676      
ziyang People's Hospital Recruiting
Siyang, Sichuan, China
Contact: min wei, MD    +8613980386078      
Sponsors and Collaborators
Sichuan Provincial People's Hospital
Xijing Hospital
Investigators
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Study Chair: Ming Zeng, MD PhD Sichuan Academy of Medical Science
Study Chair: Hongwei Zhang, MD PhD Xijing Hosptial, GI institute

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Responsible Party: ming zeng, MD, Director of Cancer Center, Sichuan Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT03223740    
Other Study ID Numbers: President Trial
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases