Benefits of a combination of chemotherapy tablets and injectable targeted therapy versus using a targeted therapy tablet alone in colorectal cancer patients
- Conditions
- Health Condition 1: C189- Malignant neoplasm of colon, unspecified
- Registration Number
- CTRI/2023/04/051850
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
-Patients must have histologically confirmed adenocarcinoma of the colon or rectum with metastatic disease or locally unresectable disease with the following mandatory prior treatment history
-The patient should have received prior FOLFOX or CAPOX based chemotherapy with or without targeted therapy and should have progressed on the same or have had poor tolerance to the regimen leading to the cessation of CAPOX or FOLFOX In patients who have received FOLFOX or CAPOX in the adjuvant setting post-resection, documented disease relapse should have occurred within 6 months of prior completion of FOLFOX or CAPOX
-The patient should have received prior FOLFIRI or CAPIRI or Irinotecan based chemotherapy with or without targeted therapy, and should have progressed on the same or have had poor tolerance to the regimen leading to the cessation of CAPIRI or FOLFIRI or Irinotecan based chemotherapy.
-The patient should have received both the above-mentioned treatment options to be eligible for the trial.
-ECOG performance status less than equal to 2.
-Participants must have adequate organ and marrow function as defined below:
-Hemoglobin more than or equal to 8 gm percent
-Leukocytes more than or equal to 3000 per mcL and Absolute neutrophil count more than or equal 1500 per mcL
-Platelets more than or equal 100000 per mcL
-Total bilirubin less than or equal 2 into institutional upper limits of normal
-AST or ALTSGPT less than or equal 5 into institutional upper limits of normal
- Calculated Creatinine clearance more than 40 ml per min
-Albumin more than or equal to 2.8 gm percent
-Adequate cardiac function as per ECG and 2 D Echo
-Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) before study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled in this protocol must also agree to use adequate contraception before the study, for the duration of study participation, and 6 months after completion of the protocol.
- Ability to understand and the willingness to sign a written informed consent document.
-Participants who are receiving any other investigational agents.
-History of allergic reactions attributed to compounds of similar chemical or biological composition to 5 FU, TAS-102, Bevacizumab, or Regorafenib.
-Uncontrolled intercurrent illness including, but not limited to, hypertension, tuberculosis, diabetes, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, renal failure (on dialysis), active gastrointestinal bleeding, cerebrovascular accidents, inflammatory bowel disease or psychiatric illness/social situations that would limit compliance with study requirements.
-The patients who have undergone major surgery in previous 6 weeks or who have healing wound
-Pregnant women and breastfeeding women are excluded from this study.
-HIV-positive, uncontrolled Hepatitis B or Hepatitis C patients are excluded from this study.
-Patients with a previous history of other cancers
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the difference in overall survival (OS) at 6 months between <br/ ><br>TAS102-Bevacizumab combination and Regorafenib. <br/ ><br>Timepoint: 53 months <br/ ><br>
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) will be defined as the time from randomization to the time of <br/ ><br>disease progression or loss to follow-up, whichever is earlier. <br/ ><br>Response rates, as per RECIST where feasible. <br/ ><br>Quality of life (QOL) will be measured using the EORTC-QLQ-30 questionnaires at the time <br/ ><br>points specified in the protocol. <br/ ><br>The side effects and adverse event profile with the combination will be reported as NCI-CTCAETimepoint: 53 months