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Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer

Primary Purpose

Anal Cancer, Carcinoma of the Appendix, Colorectal Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
palonosetron hydrochloride
placebo
Sponsored by
Alliance for Clinical Trials in Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anal Cancer focused on measuring nausea and vomiting, gastrointestinal carcinoid tumor, anal cancer, carcinoma of the appendix, colon cancer, rectal cancer, extrahepatic bile duct cancer, gallbladder cancer, gastric cancer, liver and intrahepatic biliary tract cancer, pancreatic cancer, small intestine cancer, primary peritoneal cavity cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS:

  • Diagnosis of primary gastrointestinal and/or retroperitoneal sarcoma

  • Scheduled to undergo ≥ 3000 cGy or ≥ 3 weeks of external beam radiation to the abdomen

    • Radiotherapy fields to extend between T11 and L3, and of a size ≥ 100 cm^2
  • No brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Negative pregnancy test
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Able to complete questionnaire(s) alone or with assistance
  • Willing to return to NCCTG enrolling institution for follow-up
  • Able to reliably take oral medication (for purposes of rescue medication)
  • No hypersensitivity to palonosetron hydrochloride or other selective 5-HT3 receptor antagonists
  • No comorbid systemic illness or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for study entry or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • No nausea ≤ 48 hours prior to study enrollment
  • No history of dystonic reactions to prochlorperazine or haloperidol or related agents

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

  • More than 7 days since prior agents known to have significant effects on emesis, including the following:

    • Ondansetron
    • Sedating antihistamines
    • Antipsychotics
    • Cannabinoids
    • Corticosteroids
    • Metoclopramide
    • Narcotic analgesics
    • Benzodiazepines
  • More than 7 days since prior chemotherapy other than fluorouracil or capecitabine used as a radiosensitizer
  • More than 7 days since of prior cetuximab
  • More than 7 days since prior and no concurrent oral steroids
  • No prior palonosetron hydrochloride

Sites / Locations

  • Mayo Clinic Scottsdale
  • Mayo Clinic - Jacksonville
  • Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
  • Elkhart Clinic, LLC
  • Michiana Hematology-Oncology, PC - Elkhart
  • Elkhart General Hospital
  • Howard Community Hospital
  • Center for Cancer Therapy at LaPorte Hospital and Health Services
  • Michiana Hematology-Oncology, PC - South Bend
  • Saint Joseph Regional Medical Center
  • Michiana Hematology Oncology PC - Plymouth
  • CCOP - Northern Indiana CR Consortium
  • Memorial Hospital of South Bend
  • South Bend Clinic
  • Michiana Hematology Oncology PC - La Porte
  • Siouxland Hematology-Oncology Associates, LLP
  • Mercy Medical Center - Sioux City
  • St. Luke's Regional Medical Center
  • Wesley Medical Center
  • Michiana Hematology Oncology PC - Niles
  • Lakeland Regional Cancer Care Center - St. Joseph
  • Lakeside Cancer Specialists, PLLC
  • Duluth Clinic Cancer Center - Duluth
  • CCOP - Duluth
  • Miller - Dwan Medical Center
  • Fergus Falls Medical Group, PA
  • Mayo Clinic Cancer Center
  • CCOP - Cancer Research for the Ozarks
  • St. John's Regional Health Center
  • Hulston Cancer Center at Cox Medical Center South
  • CCOP - Montana Cancer Consortium
  • St. Vincent Healthcare Cancer Care Services
  • Hematology-Oncology Centers of the Northern Rockies - Billings
  • Billings Clinic - Downtown
  • Bozeman Deaconess Cancer Center
  • St. James Healthcare Cancer Care
  • Big Sky Oncology
  • Great Falls Clinic - Main Facility
  • Sletten Cancer Institute at Benefis Healthcare
  • Northern Montana Hospital
  • St. Peter's Hospital
  • Glacier Oncology, PLLC
  • Kalispell Medical Oncology at KRMC
  • Kalispell Regional Medical Center
  • Montana Cancer Specialists at Montana Cancer Center
  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
  • CCOP - Missouri Valley Cancer Consortium
  • Creighton University Medical Center
  • Bismarck Cancer Center
  • Medcenter One Hospital Cancer Care Center
  • Mid Dakota Clinic, PC
  • St. Alexius Medical Center Cancer Center
  • Altru Cancer Center at Altru Hospital
  • Geisinger Cancer Institute at Geisinger Health
  • Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
  • Rapid City Regional Hospital
  • Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
  • Green Bay Oncology, Limited at St. Mary's Hospital
  • St. Mary's Hospital Medical Center - Green Bay
  • St. Vincent Hospital Regional Cancer Center
  • Franciscan Skemp Healthcare - La Crosse Campus
  • Holy Family Memorial Medical Center Cancer Care Center
  • Bay Area Cancer Care Center at Bay Area Medical Center
  • Door County Cancer Center at Door County Memorial Hospital
  • Green Bay Oncology, Limited - Sturgeon Bay
  • Rocky Mountain Oncology
  • Welch Cancer Center at Sheridan Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Arm I

Arm II

Arm III

Arm IV

Arm Description

Patients receive palonosetron hydrochloride IV on day 1.

Patients receive palonosetron hydrochloride IV on days 1 and 4.

Patients receive placebo IV on day 1.

Patients receive placebo IV on days 1 and 4.

Outcomes

Primary Outcome Measures

Complete Response (no Episodes of Nausea or Vomiting)

Secondary Outcome Measures

Time to Treatment Failure, Defined as a Single Episode of Vomiting, Daily Nausea Score of Moderate or Greater, or Taking ≥ 3 Prochlorperazine or Haloperidol Tablets Per Day
Proportion of Patients Reporting Treatment Failure
Tolerability and Adverse Events as Assessed by NCI CTC v 3.0
Average Level of Nausea Reported and the Proportion of Patients Experiencing a Complete Response Independent of Treatment Arm

Full Information

First Posted
May 15, 2009
Last Updated
October 20, 2017
Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00903396
Brief Title
Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer
Official Title
A Pilot Phase II, Randomized, Double Blind Trial of Palonosetron Versus Placebo to Prevent Radiation Therapy Induced Nausea and Vomiting
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
September 2009 (Actual)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Palonosetron hydrochloride may prevent nausea and vomiting caused by radiation therapy. It is not yet known whether palonosetron hydrochloride is more effective than a placebo in preventing nausea and vomiting. PURPOSE: This randomized phase II trial is studying the side effects of palonosetron hydrochloride and to see how well it works in preventing nausea and vomiting caused by radiation therapy in patients with primary abdominal cancer.
Detailed Description
OBJECTIVES: Evaluate the rate of complete responses, defined as no vomiting and no nausea, in patients with primary gastrointestinal and/or retroperitoneal sarcomas treated with two different dosing schedules of palonosetron hydrochloride during abdominal radiotherapy as part of their cancer treatment. Determine the tolerability of palonosetron hydrochloride vs placebo in these patients. Validate patient diaries for assessing nausea and vomiting by comparing with alternative methods for measuring nausea and vomiting in order to determine the optimal approach for future studies. OUTLINE: Patients are stratified according to planned radiotherapy duration (< 5 weeks vs ≥ 5 weeks), planned concurrent fluorouracil ( yes vs no), and gender. Patients are randomized to 1 of 4 treatment arms. Arm I: Patients receive palonosetron hydrochloride IV on day 1. Arm II: Patients receive palonosetron hydrochloride IV on days 1 and 4. Arm III: Patients receive placebo IV on day 1. Arm IV: Patients receive placebo IV on days 1 and 4. In all arms, courses repeat weekly during radiotherapy in the absence of disease progression or unacceptable toxicity. Patients complete nausea and vomiting questionnaires and diaries at baseline and daily during radiotherapy. Patients also complete symptom experience diaries weekly during radiotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Cancer, Carcinoma of the Appendix, Colorectal Cancer, Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Gastric Cancer, Gastrointestinal Carcinoid Tumor, Liver Cancer, Nausea and Vomiting, Pancreatic Cancer, Primary Peritoneal Cavity Cancer, Small Intestine Cancer
Keywords
nausea and vomiting, gastrointestinal carcinoid tumor, anal cancer, carcinoma of the appendix, colon cancer, rectal cancer, extrahepatic bile duct cancer, gallbladder cancer, gastric cancer, liver and intrahepatic biliary tract cancer, pancreatic cancer, small intestine cancer, primary peritoneal cavity cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive palonosetron hydrochloride IV on day 1.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients receive palonosetron hydrochloride IV on days 1 and 4.
Arm Title
Arm III
Arm Type
Placebo Comparator
Arm Description
Patients receive placebo IV on day 1.
Arm Title
Arm IV
Arm Type
Placebo Comparator
Arm Description
Patients receive placebo IV on days 1 and 4.
Intervention Type
Drug
Intervention Name(s)
palonosetron hydrochloride
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Complete Response (no Episodes of Nausea or Vomiting)
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Time to Treatment Failure, Defined as a Single Episode of Vomiting, Daily Nausea Score of Moderate or Greater, or Taking ≥ 3 Prochlorperazine or Haloperidol Tablets Per Day
Time Frame
Up to 2 years
Title
Proportion of Patients Reporting Treatment Failure
Time Frame
Up to 2 years
Title
Tolerability and Adverse Events as Assessed by NCI CTC v 3.0
Time Frame
Up to 2 years
Title
Average Level of Nausea Reported and the Proportion of Patients Experiencing a Complete Response Independent of Treatment Arm
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of primary gastrointestinal and/or retroperitoneal sarcoma Scheduled to undergo ≥ 3000 cGy or ≥ 3 weeks of external beam radiation to the abdomen Radiotherapy fields to extend between T11 and L3, and of a size ≥ 100 cm^2 No brain metastases PATIENT CHARACTERISTICS: ECOG performance status 0-2 Negative pregnancy test Not pregnant or nursing Fertile patients must use effective contraception Able to complete questionnaire(s) alone or with assistance Willing to return to NCCTG enrolling institution for follow-up Able to reliably take oral medication (for purposes of rescue medication) No hypersensitivity to palonosetron hydrochloride or other selective 5-HT3 receptor antagonists No comorbid systemic illness or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for study entry or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens No nausea ≤ 48 hours prior to study enrollment No history of dystonic reactions to prochlorperazine or haloperidol or related agents PRIOR CONCURRENT THERAPY: See Disease Characteristics More than 7 days since prior agents known to have significant effects on emesis, including the following: Ondansetron Sedating antihistamines Antipsychotics Cannabinoids Corticosteroids Metoclopramide Narcotic analgesics Benzodiazepines More than 7 days since prior chemotherapy other than fluorouracil or capecitabine used as a radiosensitizer More than 7 days since of prior cetuximab More than 7 days since prior and no concurrent oral steroids No prior palonosetron hydrochloride
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Yvette Halyard, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Mayo Clinic Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5499
Country
United States
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
City
Moline
State/Province
Illinois
ZIP/Postal Code
61265
Country
United States
Facility Name
Elkhart Clinic, LLC
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514-2098
Country
United States
Facility Name
Michiana Hematology-Oncology, PC - Elkhart
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514
Country
United States
Facility Name
Elkhart General Hospital
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46515
Country
United States
Facility Name
Howard Community Hospital
City
Kokomo
State/Province
Indiana
ZIP/Postal Code
46904
Country
United States
Facility Name
Center for Cancer Therapy at LaPorte Hospital and Health Services
City
La Porte
State/Province
Indiana
ZIP/Postal Code
46350
Country
United States
Facility Name
Michiana Hematology-Oncology, PC - South Bend
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46545-1470
Country
United States
Facility Name
Saint Joseph Regional Medical Center
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46545-1470
Country
United States
Facility Name
Michiana Hematology Oncology PC - Plymouth
City
Plymouth
State/Province
Indiana
ZIP/Postal Code
46563
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Memorial Hospital of South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
South Bend Clinic
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
Facility Name
Michiana Hematology Oncology PC - La Porte
City
Westville
State/Province
Indiana
ZIP/Postal Code
46391
Country
United States
City
Bettendorf
State/Province
Iowa
ZIP/Postal Code
52722
Country
United States
Facility Name
Siouxland Hematology-Oncology Associates, LLP
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Mercy Medical Center - Sioux City
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
St. Luke's Regional Medical Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Wesley Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Michiana Hematology Oncology PC - Niles
City
Niles
State/Province
Michigan
ZIP/Postal Code
49120
Country
United States
Facility Name
Lakeland Regional Cancer Care Center - St. Joseph
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Lakeside Cancer Specialists, PLLC
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Duluth Clinic Cancer Center - Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805-1983
Country
United States
Facility Name
CCOP - Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Miller - Dwan Medical Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Fergus Falls Medical Group, PA
City
Fergus Falls
State/Province
Minnesota
ZIP/Postal Code
56537
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
CCOP - Cancer Research for the Ozarks
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States
Facility Name
St. John's Regional Health Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Hulston Cancer Center at Cox Medical Center South
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
CCOP - Montana Cancer Consortium
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
St. Vincent Healthcare Cancer Care Services
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Hematology-Oncology Centers of the Northern Rockies - Billings
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Billings Clinic - Downtown
City
Billings
State/Province
Montana
ZIP/Postal Code
59107-7000
Country
United States
Facility Name
Bozeman Deaconess Cancer Center
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
St. James Healthcare Cancer Care
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Big Sky Oncology
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405-5309
Country
United States
Facility Name
Great Falls Clinic - Main Facility
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Sletten Cancer Institute at Benefis Healthcare
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Northern Montana Hospital
City
Havre
State/Province
Montana
ZIP/Postal Code
59501
Country
United States
Facility Name
St. Peter's Hospital
City
Helena
State/Province
Montana
ZIP/Postal Code
59601
Country
United States
Facility Name
Glacier Oncology, PLLC
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Medical Oncology at KRMC
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Regional Medical Center
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Montana Cancer Specialists at Montana Cancer Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59807-7877
Country
United States
Facility Name
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59807
Country
United States
Facility Name
CCOP - Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68106
Country
United States
Facility Name
Creighton University Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131-2197
Country
United States
Facility Name
Bismarck Cancer Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Medcenter One Hospital Cancer Care Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Mid Dakota Clinic, PC
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
St. Alexius Medical Center Cancer Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58502
Country
United States
Facility Name
Altru Cancer Center at Altru Hospital
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58201
Country
United States
Facility Name
Geisinger Cancer Institute at Geisinger Health
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-0001
Country
United States
Facility Name
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18711
Country
United States
Facility Name
Rapid City Regional Hospital
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301-3526
Country
United States
Facility Name
Green Bay Oncology, Limited at St. Mary's Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
St. Mary's Hospital Medical Center - Green Bay
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
St. Vincent Hospital Regional Cancer Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54307-3508
Country
United States
Facility Name
Franciscan Skemp Healthcare - La Crosse Campus
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Holy Family Memorial Medical Center Cancer Care Center
City
Manitowoc
State/Province
Wisconsin
ZIP/Postal Code
54221-1450
Country
United States
Facility Name
Bay Area Cancer Care Center at Bay Area Medical Center
City
Marinette
State/Province
Wisconsin
ZIP/Postal Code
54143
Country
United States
Facility Name
Door County Cancer Center at Door County Memorial Hospital
City
Sturgeon Bay
State/Province
Wisconsin
ZIP/Postal Code
54235-1495
Country
United States
Facility Name
Green Bay Oncology, Limited - Sturgeon Bay
City
Sturgeon Bay
State/Province
Wisconsin
ZIP/Postal Code
54235
Country
United States
Facility Name
Rocky Mountain Oncology
City
Casper
State/Province
Wyoming
ZIP/Postal Code
82609
Country
United States
Facility Name
Welch Cancer Center at Sheridan Memorial Hospital
City
Sheridan
State/Province
Wyoming
ZIP/Postal Code
82801
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer

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