Colorectal Cancer Clinical Trial
Official title:
Adjuvant Chemoimmunotherapy for Colorectal Cancer
RATIONALE: Biological therapies use different ways to stimulate the immune system and stop
cancer cells from growing. Combining chemotherapy with biological therapy may kill more
tumor cells.
PURPOSE: Randomized phase III trial to compare the effectiveness of treatment using
levamisole with treatment using interferon alfa and combination chemotherapy consisting of
fluorouracil and leucovorin in patients with stage II or stage III colorectal cancer.
OBJECTIVES:
- Assess the efficacy of the addition of levamisole or alfa interferon to fluorouracil
and leucovorin calcium (folinic acid) as an adjuvant treatment of intraperitoneal
colorectal cancer.
OUTLINE: This is a three arm study. Patients are randomized to receive either levamisole,
alfa interferon, or no treatment.
- Arm I: Patients receive levamisole PO for 3 days every 2 weeks for 6 months before and
after surgery. Fluorouracil IV bolus and leucovorin calcium (folinic acid) IV over 1
hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery.
- Arm II: Patients receive alfa interferon-2a SC on 3 alternate days for a week before
surgery and for 6 months after surgery. Fluorouracil IV bolus and folinic acid IV over
1 hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery.
- Arm III: Patients undergo surgery followed by fluorouracil IV bolus and folinic acid IV
over 1 hour on days 1-5 every 4 weeks for 6 cycles.
Patients are followed every 3 months for 2 years, then every 6 months.
PROJECTED ACCRUAL: 350 patients per arm will be accrued for a total of 1,050 patients.
;
Allocation: Randomized, Primary Purpose: Treatment
| 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 |
NCT03167125 -
Participatory Research to Advance Colon Cancer Prevention
|
N/A | |
| Completed |
NCT03181334 -
The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation
|
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 |