Colorectal Cancer Clinical Trial
Official title:
A Pilot Phase II, Randomized, Double Blind Trial of Palonosetron Versus Placebo to Prevent Radiation Therapy Induced Nausea and Vomiting
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05400122 -
Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer
|
Phase 1 | |
Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
Completed |
NCT00098787 -
Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer
|
Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT05425940 -
Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer
|
Phase 3 | |
Suspended |
NCT04595604 -
Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery.
|
N/A | |
Completed |
NCT03414125 -
Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening
|
N/A | |
Completed |
NCT02963831 -
A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
|
Phase 1/Phase 2 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Terminated |
NCT01847599 -
Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib
|
N/A | |
Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
Recruiting |
NCT03874026 -
Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03181334 -
The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation
|
N/A | |
Completed |
NCT03167125 -
Participatory Research to Advance Colon Cancer Prevention
|
N/A | |
Recruiting |
NCT04258137 -
Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study
|
N/A | |
Recruiting |
NCT05568420 -
A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
|
||
Recruiting |
NCT02972541 -
Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer
|
N/A | |
Completed |
NCT02876224 -
Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors
|
Phase 1 | |
Completed |
NCT01943500 -
Collection of Blood Specimens for Circulating Tumor Cell Analysis
|
N/A |