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A Randomized Phase II Trial of Neoadjuvant Chemotherapy Compared With Chemoradiotherapy in Gastric Adenocarcinoma

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ClinicalTrials.gov Identifier: NCT02301481
Recruitment Status : Recruiting
First Posted : November 26, 2014
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Jing Jin, M.D., Chinese Academy of Medical Sciences

Brief Summary:
This prospective, randomized phase II study is designed to evaluate weather neoadjuvant chemoradiotherapy is superior to neoadjuvant chemotherapy with both followed by surgery and postoperative chemotherapy for locally advanced gastric adenocarcinoma.

Condition or disease Intervention/treatment Phase
Stomach Neoplasms Neoadjuvant Therapy Chemoradiotherapy Chemotherapy Radiation: SIB-IMRT Drug: S-1 Procedure: Surgery Drug: SOX Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Phase II Trial of Neoadjuvant Chemotherapy Compared With Concomitant Boost Intensity-Modulated Radiotherapy With S-1 in Locally Advanced Gastric Adenocarcinoma
Study Start Date : January 2014
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin

Arm Intervention/treatment
Experimental: Neoadjuvant Chemoradiotherapy (NCRT)
NCRT arm receives intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) (45.1Gy and 40.04Gy in 22 fractions) concurrently with oral S-1(40mg/m2, orally twice daily every weekday) followed by surgery and four to six cycles of SOX at the same dosage with NCT arm.
Radiation: SIB-IMRT
45.1Gy and 40.04Gy in 22 fractions using intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) to primary tumor

Drug: S-1
40mg/m2, orally twice daily every weekday concurrently with radiotherapy treatment
Other Name: TS-1

Procedure: Surgery
Surgery, preferred D2 lymphadenectomy

Drug: SOX
SOX (S-1: 40~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle)
Other Name: TS-1; Oxaliplatin for injection

Active Comparator: Neoadjuvant Chemotherapy (NCT)
NCT arm consists of neoadjuvant three cycles of SOX(S-1: 40~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle followed by radical surgery and another postoperative three cycles of SOX.
Procedure: Surgery
Surgery, preferred D2 lymphadenectomy

Drug: SOX
SOX (S-1: 40~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle)
Other Name: TS-1; Oxaliplatin for injection




Primary Outcome Measures :
  1. R0 resection rate [ Time Frame: 2-3 months ]
    The surgical procedure was total or subtotal gastrectomy with recommended D2 lymphadenectomy 4-6 weeks after neoadjuvant therapy.


Secondary Outcome Measures :
  1. Pathological response rate [ Time Frame: 2-3 months ]
    Pathological response were classified into three grades.Grade I signifies that there is little shrinkage in the tumor; only mild regression in the tumor cells is observed under themicroscope. Grade II shows gross reduction in size of the tumor and marked regression in the cancer cells microscopically, yet viable nests of cancer tissue are still visible. Grade III implies complete or almost total resolution of the tumor on exploration, and disappearance of the tumor tissue microscopically; only remnants of degenerated cancer cells can be seen (so-called ghost cancer cells).

  2. Tumor down-staging [ Time Frame: 2-3 months ]
    Down-staging was considered as any stage reduction between clinical and pathologic stage.

  3. Postoperative complications [ Time Frame: 2-3 months ]
    During hospital stay and within the first 30 days after completion of surgery.

  4. Acute chemotherapy/Chemoradiotherapy toxicities [ Time Frame: 6-8 months ]
    chemotherapy toxicities are evaluated by NCI-CTC version 4.0 and radiotherapy toxicities are graded using the RTOG/EORTC Radiation Morbidity Scoring Schema.

  5. Distant metastasis free survival [ Time Frame: 3 years ]
  6. Locoregional recurrence free survival [ Time Frame: 3 years ]
  7. Overall survival [ Time Frame: 3 years ]

Other Outcome Measures:
  1. Comparison of dosimetric differences between radiation techniques [ Time Frame: 1 year ]
    To compare the dosimetric differences between the volumetric-modulated arc therapy (VMAT), Tomotherapy and intensity-modulated radiotherapy (IMRT) techniques in treatment planning.



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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:

  • Histologically or cytologically proven locally advanced gastric adenocarcinoma in patients staged as cT3-4N0M0 or anyTN+M0
  • No distant metastasis in liver,lung,bone,central nervous system(CNS),no peritoneal transplantation
  • No prior abdominal or pelvic radiotherapy
  • Karnofsky performance status(KPS)≥ 70, predictive life span no less than 6 months
  • Patients must have normal organ and marrow function as defined below: Leukocytes: greater than or equal to 3,000 G/L; Platelets: greater than or equal to 100,000/mm3 .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit; Creatinine within normal upper limits
  • Informed consent

Exclusion Criteria:

  • Any prior chemotherapy or other cancer treatment prior to this protocol
  • Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer
  • With any distant metastasis in liver,lung,bone,CNS,or peritoneal transplantation
  • History of allergic reactions attributed to similar chemical or biologic complex to S-1 or Xeloda or Oxaliplatin
  • Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
  • History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
  • History of prior radiation to the abdomen
  • Pregnant or lactating females

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): NCT02301481


Contacts
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Contact: Jing Jin, MD +8613601365130 jingjin1025@163.com

Locations
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China
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) Recruiting
Beijing, China, 100021
Contact: Xin Wang, MD    +8613311583220    beryl_wx2000@163.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences

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Responsible Party: Jing Jin, M.D., MD, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02301481     History of Changes
Other Study ID Numbers: NCC2015ST-09
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
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Adenocarcinoma
Stomach Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Oxaliplatin
Antineoplastic Agents