A Phase II Trial of Neoadjuvant Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Chemoradiation
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|ClinicalTrials.gov Identifier: NCT04308837|
Recruitment Status : Recruiting
First Posted : March 16, 2020
Last Update Posted : March 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer Stomach Cancer||Drug: Paclitaxel Drug: Carboplatin Drug: Dexamethasone Drug: Diphenhydramine Drug: Famotidine Drug: Palonosetron Radiation: 3D conformal or intensity modulated radiotherapy Procedure: Surgical resection Radiation: Adjuvant Chemotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The study design involves a single arm of patients that will all receive the same treatment.|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Neoadjuvant Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Chemoradiation (Carboplatin and Taxol) as First Line Treatment for Patients With Local Regional Advanced Gastric Cancer|
|Actual Study Start Date :||July 31, 2018|
|Estimated Primary Completion Date :||July 31, 2021|
|Estimated Study Completion Date :||July 31, 2028|
Experimental: Patients With Local Regional Advanced Gastric Cancer
Patients with local regional advanced gastric cancer after at least 4 weeks post diagnostic laparoscopy and HIPEC, will receive all of the treatments described in the study protocol.
50 mg/m2 given by intravenous infusion on days 1, 8, 15, 22 and 29.
Carboplatin AUC = 2 given by intravenous infusion on days 1, 8, 15, 22 and 29.
All patients receiving Paclitaxel will receive institutional standard premedications, which include Dexamethasone (10 mg IVPB)
All patients receiving Paclitaxel will receive institutional standard premedications, which include diphenhydramine (50mg IVP)
All patients receiving Paclitaxel will receive institutional standard premedications, which include Famotidine (20mg IVPB)
All patients receiving Paclitaxel will receive institutional standard premedications, which include Palonosetron (0.25mg IVP)
Radiation: 3D conformal or intensity modulated radiotherapy
Treatment will be given 5 days per week. Photon beams >6 MV are required. Treatment may be delivered either by a 3D conformal technique or IMRT. IMRT via dynamically moving MLCs, step-and-shoot with a multileaf collimator, Rapid Arc, binary multileaf collimator, and tomotherapy are allowed. Proton therapy is not allowed.
Other Name: IMRT
Procedure: Surgical resection
Surgical resection will constitute subtotal or total gastrectomy (depending on tumor size and location) and D2 lymphadenectomy.
Radiation: Adjuvant Chemotherapy
The patient will begin adjuvant chemotherapy 4-12 weeks after surgery. The adjuvant chemotherapy will consist of FOLFOX every 2 weeks for 6 cycles (i.e. 3 months)
- Pathological Response [ Time Frame: at time of surgical resection ]The pathological complete response (the lack of all signs of cancer in tissue samples), at the time of surgical resection. This will be determined using a four-category tumor regression score system that evaluates the response of the cancer cells to the treatment. RECIST - Complete Response (CR), Partial Response (PR) Progressive Disease (PD), and Stable Disease (SD)
- Overall Survival (OS) [ Time Frame: 6 years ]OS is defined as the time from the first dose of study treatment to the date of death (whatever the cause).
- Disease-free Survival [ Time Frame: 6 years ]The length of time after treatment ends that the patient survives without any signs or symptoms.
- Peritoneal Disease-free Survival [ Time Frame: 6 years ]The length of time after treatment ends that the patient survives without any peritoneal signs or symptoms.
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): NCT04308837
|Contact: Margaret Hofstedt, BSfirstname.lastname@example.org|
|Contact: Eliahu Bekhoremail@example.com|
|United States, New York|
|Mount Sinai West||Recruiting|
|New York, New York, United States, 10019|
|Mount Sinai St. Luke's||Recruiting|
|New York, New York, United States, 10025|
|Icahn School of Medicine at Mount Sinai||Recruiting|
|New York, New York, United States, 10029|
|Principal Investigator:||Spiros Hiotis, MD, PhD||Icahn School of Medicine at Mount Sinai|