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D2 Resection and HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) in Locally Advanced Gastric Carcinoma (GASTRICHIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01882933
Recruitment Status : Active, not recruiting
First Posted : June 21, 2013
Last Update Posted : April 19, 2023
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Brief Summary:

A prospective, opened, multicentric, randomised, phase III trial with two arms:

  • Arm A: curative gastrectomy with D1-D2 lymph node dissection + HIPEC with oxaliplatin
  • Arm B: curative gastrectomy with D1-D2 lymph node dissection

Main objective: Compare overall 5-year survival rates in patients surgically treated for advanced gastric adenocarcinoma (T3, T4 and/or N+ and/or with positive peritoneal cytology), treated either with curative gastrectomy and adjuvant HIPEC, or with curative gastrectomy alone.


Condition or disease Intervention/treatment Phase
Gastric Adenocarcinoma Drug: HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) with oxaliplatin Procedure: Curative gastrectomy Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 367 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: GASTRICHIP : D2 Resection and HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) in Locally Advanced Gastric Carcinoma. A Randomized and Multicentric Phase III Study.
Actual Study Start Date : June 2013
Estimated Primary Completion Date : May 2026
Estimated Study Completion Date : May 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
Drug Information available for: Oxaliplatin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Curative Gastrectomy + HIPEC
Curative gastrectomy with D1-D2 lymph node dissection + HIPEC with oxaliplatin
 Drug: HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) with oxaliplatin
After the D2 resection is complete HIPEC can start. A roller pump forces the chemotherapy solution (oxaliplatin 250 mg/m² with 2 Liters of G5%/m²) into the abdomen through the inflow catheter and pulls it out through the drains. A heat exchanger keeps the intraperitoneal fluid at 42°-43°C.

Procedure: Curative gastrectomy
All the patients will undergo a D1-D2 gastrectomy carried out according to Japanese guidelines and to the European recommendations for the preservation of spleen and pancreas
Curative Gastrectomy
Curative gastrectomy with D1-D2 lymph node dissection
 Procedure: Curative gastrectomy
All the patients will undergo a D1-D2 gastrectomy carried out according to Japanese guidelines and to the European recommendations for the preservation of spleen and pancreas


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]
    From the date of surgery to the date of death or to the end of follow-up


Secondary Outcome Measures :
  1. Recurrence-free survival [ Time Frame: 5 years ]
    From the date of surgery to the date of recurrence or to the end of follow-up

  2. Recurrence-free survival [ Time Frame: 3 years ]
    From the date of surgery to the date of recurrence or to the end of follow-up

  3. Locoregional-free survival [ Time Frame: 5 years ]
    From the date of surgery to the date of locoregional recurrence or to the end of follow-up

  4. Treatment-related morbidity [ Time Frame: During the 60th postoperative days ]
    Common Terminology Criteria for Adverse Events v4.0

  5. Treatment-related mortality [ Time Frame: During the 60th postoperative days ]
  6. Score QLQ-C30 [ Time Frame: 3 months (M3), 6 months (M6) and 12 months (M12) after surgery +/- HIPEC procedure. ]
    Quality of life is assessed with EORTC questionnaire QLQ-C30

  7. Score QLQ-STO 22 [ Time Frame: 3 months (M3), 6 months (M6) and 12 months (M12) after surgery +/- HIPEC procedure. ]
    Quality of life is assessed with EORTC questionnaire QLQ-STO 22


Eligibility Criteria
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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:

  • 18 < age ≤ 75 years old
  • White blood cells > 3,500/mm3, neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3
  • Good renal functions, serum creatinine values being < 1.5 mg/dl and creatinine clearance > 60 ml/min
  • Performance Status ≤1, Karnofsky Index ≥ 70%
  • Serum bilirubin ≤ 2 mg/dl
  • Having given written informed consent prior to any procedure related to the study.
  • Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research
  • Not under any administrative or legal supervision
  • Histologically evidenced resectable T3 or T4 gastric adenocarcinoma for which a curative gastrectomy is scheduled, with invasion into the serosa AND/OR lymph node metastasis (determined from data obtained by endoscopic ultrasound and chest, abdomen and pelvis CT scan) AND/OR positive peritoneal cytology (sampled during the preoperative laparoscopy).

AND/OR

  • Perforated gastric adenocarcinoma AND/OR
  • Siewert III adenocarcinoma of the cardia for which a gastrectomy by exclusive abdominal laparotomy is scheduled

  • Females of childbearing age potential and male subjects with partners of childbearing potential using efficient contraceptive measures (as judged by the investigator).Subjects randomised in the arm with HIPEC should be informed and accept that these requirements should also extend to :

    • 4 months after the treatment with Oxaliplatin for female subjects,
    • 6 months after the treatment with Oxaliplatin for male subjects.

Exclusion Criteria:

  • Prior malignant tumors with detectable signs of recurrence
  • Gastric stump adenocarcinoma
  • Presence of comorbidities, notably serious chronic diseases or organ failure General conditions
  • Any subject in exclusion period of a previous study according to applicable regulations
  • Pregnancy or breastfeeding
  • Females of childbearing age potential or male subjects with partners of childbearing potential not using medically accepted contraceptive measures, as judged by the investigator Interfering substance
  • Contraindication to any drug contained in the chemotherapy regimen Specific to the study
  • Life threatening toxicity before surgery
  • Distant metastases (liver, lung. ovaries, etc)
  • Tumoral infiltration of the head or body of the pancreas
  • Patients presenting an adenocarcinoma of the cardia Siewert I or II
  • Existence of macroscopic peritoneal implants
  • Patients with clinically significant ascites (> 500 cc) even if cytology is negative for cancer cells, in the absence of other non-malignant causes of ascites
Contacts and Locations
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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): NCT01882933


Locations
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Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Olivier GLEHEN, MD Service de Chirurgie Générale Digestive et Endocrinienne, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01882933    
Other Study ID Numbers: 2012.761
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: April 19, 2023
Last Verified: April 2023
Keywords provided by Hospices Civils de Lyon:
Gastric adenocarcinoma
HIPEC
Oxaliplatin
Signet ring cell
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