Trial Summary
What is the purpose of this trial?VAPOR-C is a randomised study of the impact of IV versus inhaled anaesthesia (propofol versus sevoflurane) and lidocaine versus no lidocaine on duration of disease free survival inpatients with either colorectal or non small cell lung cancer.
Is the drug Propofol, Sevoflurane a promising treatment for cancer during anesthesia?Propofol shows promise as a treatment during cancer surgery because it may help reduce cancer cell growth and improve long-term survival compared to Sevoflurane. It has potential anticancer properties and might be better for patients undergoing surgery for cancer.1012131415
What safety data exists for anesthesia treatments like Lidocaine and Propofol in cancer trials?The provided research does not contain safety data for anesthesia treatments such as Lidocaine, Propofol, or related drugs. Instead, it focuses on the safety and effects of amifostine, a cytoprotective agent used during radiotherapy and chemotherapy, with reported side effects including nausea, vomiting, skin reactions, and rare cases of severe mucocutaneous reactions.34569
What data supports the idea that Anesthesia for Cancer is an effective treatment?The available research does not provide specific data supporting the effectiveness of Anesthesia for Cancer as a treatment. Instead, it focuses on other drugs like 5-fluorouracil (5-FU) and gemcitabine for treating colorectal and pancreatic cancers. These drugs have shown some benefits in terms of survival and quality of life, but there is no mention of Anesthesia for Cancer in the context of these studies.127811
Do I have to stop taking my current medications for the trial?The trial requires you to stop taking certain medications that are moderate-strong inhibitors of the CYP1A2 and CYP3A4 metabolic pathways within 72 hours before surgery. This includes specific antibiotics, antifungals, antiretrovirals, antidepressants, calcium-channel blockers, monoclonal antibodies, and other strong cytochrome P450 3A4 inhibitors. If you're taking any of these, you may need to stop them before participating.
Eligibility Criteria
The VAPOR-C trial is for adults with Stage I-III colorectal or non-small cell lung cancer (NSCLC) who are scheduled for elective surgery that will last at least 2 hours and require a hospital stay of 2+ nights. Participants must be able to follow the study plan and have an ASA score of 1-3. Exclusions include weight under 45kg, significant liver disease, recent other cancers, certain drug use, and allergies to trial drugs.Inclusion Criteria
My surgery is expected to last 2 or more hours and will require a hospital stay of 2 or more nights.
I am scheduled for surgery to remove my cancer with the goal of curing it.
Exclusion Criteria
I do not have severe liver disease.
I or my family have a history of malignant hyperthermia or porphyria.
I weigh less than 45kg.
My cancer has spread to distant parts of my body.
Treatment Details
This study compares IV anesthesia (propofol) with inhaled anesthesia (sevoflurane), along with the addition or absence of lidocaine. The goal is to see how these different anesthesia methods affect cancer-free survival time after surgery in patients with colorectal or NSCLC.
4Treatment groups
Active Control
Group I: AActive Control2 Interventions
Sevoflurane + intravenous lidocaine
Group II: BActive Control1 Intervention
Sevoflurane
Group III: CActive Control2 Interventions
Propofol TIVA + intravenous lidocaine
Group IV: DActive Control1 Intervention
Propofol TIVA
Find a clinic near you
Research locations nearbySelect from list below to view details:
Cleveland ClinicCleveland, OH
University of Pittsburgh Medical CenterPittsburgh, PA
The University of Texas MD Anderson Cancer CentreHouston, TX
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Who is running the clinical trial?
Peter MacCallum Cancer Centre, AustraliaLead Sponsor
National Health and Medical Research Council, AustraliaCollaborator
Australian and New Zealand College of AnaesthetistsCollaborator
Victorian Comprehensive Cancer CentreCollaborator
References
Current treatment approaches in colorectal cancer. [2018]Fluorouracil (5-FU) is still the mainstay of adjuvant treatment for colorectal cancer. Two trials have shown a disease-free and overall survival benefit for 5-FU combined with levamisole in patients with node-positive colon cancer. This regimen is fairly well tolerated and devoid of long-term sequelae, and is now considered standard treatment for node-positive colon cancer. One trial showed a modest improvement in disease-free survival for the semustine/vincristine/5-FU combination; the leukemogenicity and renal toxicity caused by semustine have prevented this regimen from being adopted. Although administering 5-FU directly into the portal vein may improve disease-free survival, most trials have failed to demonstrate a reduction in the incidence of hepatic metastases. This technique, therefore, remains investigational. Several trials in rectal cancer show an advantage for 5-FU combined with semustine and radiation therapy in terms of disease-free survival, overall survival, or both; the contribution of semustine has been questioned and is currently being investigated. In patients with metastatic disease, hepatic arterial infusion of floxuridine produces a higher objective response rate than intravenous administration, but has not resulted in a survival benefit; hepatobiliary toxicity limits the duration of therapy. Biochemical modulation of 5-FU with leucovorin increases the response rate produced by 5-FU alone; a survival benefit has also been observed. N-(phosphonacetyl)-L-aspartate has shown initial promise in combination with high-dose 5-FU infusions. Among the many new drugs tested, only tauromustine seems worthy of further study.
[Non surgical treatment of pancreatic cancers]. [2006]Pancreatic cancer is a disease difficult to treat. Diagnosis is late, cancer remaining clinically unapparent even if locally advanced or metastatic. Few patients can be submitted to curative surgery. Even if resection is possible, 5-year survival varies from 0% to 18% according to series. Some data suggest that chemotherapy with or without radiotherapy could influence disease free survival but a benefit on overall survival has not been demonstrated. For locally advanced disease, the results of a trial published in 1968, showed that a combination of radiotherapy and 5-Fluorouracil (5FU) improved median survival as compared to radiotherapy alone (5.5 versus 10 months). Since then, no progress has been achieved. At the present time, survival of patients with metastatic pancreatic cancer cannot be improved. Very recently, a new agent, gemcitabine, has been compared to 5FU. Criteria for activity were based on clinical improvement analgesia consumption, performance status and weight gain. Twenty-four percent of the patients treated with gemcitabine had a clinical benefit as compared to 5% for those treated with 5FU. Other studies comparing chemotherapy to best supportive care show a significant decrease of depression and anxiety as well as an improvement in quality of life for patients being treated.
A phase II trial of subcutaneous amifostine and radiation therapy in patients with head and neck cancer. [2020]This phase II trial was designed to verify that subcutaneous (SC) administration of Amifostine (Ethyol) protects against radiation therapy (RT)-induced xerostomia and ameliorates amifostine-related side effects (including nausea, vomiting, and hypotension). Patients receiving amifostine SC plus RT had a 56% incidence of acute xerostomia, comparable with previous phase III data with intravenous administration of amifostine. There was good tolerability, with cutaneous toxicity as the most significant side effect. These data suggest that amifostine SC provided comparable protection against RT-induced acute xerostomia as amifostine intravenously.
Amifostine-induced toxic epidermal necrolysis during radiotherapy: a case report. [2019]Amifostine is a phosphorylated aminothiol prodrug that can selectively protect normal tissues against the toxic effects of chemotherapy and radiotherapy. In clinical use amifostine is well tolerated and may rarely cause allergic reactions. Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are two closely related entities that present with severe acute mucocutaneous reactions most often triggered by drugs. There are only two case reports related to the use of amifostine during radiotherapy, one case with SJS and the other with SJS-TEN overlap. In this paper, a case with amifostine-induced TEN during radiotherapy is presented.
Ongoing prospective multicenter safety study of the cytoprotectant amifostine given subcutaneously: overview of trial design. [2019]The study is a prospective, open-label, multicenter safety study designed to identify treatment-related side effects of amifostine (Ethyol, WR-2721; MedImmune, Inc, Gaithersburg, MD) administered as a subcutaneous injection for the prevention of radiation-induced toxicities. More than 100 patients (68 males, 33 females; median age, 64 years) received 500 mg of amifostine by subcutaneous injection before daily radiation therapy. Four types of targeted adverse events were examined as to their occurrence and possible relationship with amifostine. These adverse events included nausea/vomiting, local skin reactions, skin rashes, and hypotension.
Intravenous amifostine during chemoradiotherapy for head-and-neck cancer: a randomized placebo-controlled phase III study. [2013]Clinical trials demonstrated the efficacy and safety of intravenous (i.v.) or subcutaneous (s.c.) amifostine for reducing xerostomia and mucositis after radiotherapy or radiochemotherapy for head-and-neck cancer. This randomized, double-blinded, placebo-controlled, phase III study evaluated the efficacy and safety of i.v. amifostine during radiochemotherapy for head-and-neck cancer.
Pancreatic cancer: are we moving forward yet? Highlights from the Gastrointestinal Cancers Symposium. Orlando, FL, USA. January 20th, 2007. [2018]Survival for patients with pancreatic cancer remains abysmal. Standard treatment for resected and locally advanced disease usually consists of 5-fluorouracil (5-FU, either bolus or continuous infusion) and external beam radiation. However, recent studies have shown the role of gemcitabine either used alone or incorporated with 5-FU and external beam radiation in this setting. Gemcitabine and erlotinib (Tarceva) are currently the only standard chemotherapeutic agents approved by FDA for the treatment of advanced pancreatic cancer. Combination chemotherapy trials incorporating gemcitabine with other agents such as 5-FU, oxaliplatin, or capecitabine generally show improved outcomes in objective response rates but with little or no improvement in survival in phase III trials. In this article, the author summarizes the key studies in pancreatic cancer presented at the 2007 Gastrointestinal Cancers Symposium (Orlando, FL, USA; January, 2007). The studies discussed here include preliminary results of the Cancer and Leukemia Group B (CALGB) phase III trial of gemcitabine plus bevacizumab and activity of other targeted agents including sorafenib, cetuximab, retrospective and population-based studies evaluating the role of chemo-radiotherapy and radiotherapy, an analysis of 3,306 patients from the Surveillance, Epidemiology and End Results (SEER) database evaluating the predictive role of lymph nodes in survival following pancreatectomy and the assessment of novel agents, such as Genexol-PM and S-1.
Current status of adjuvant therapy for colon cancer. [2023]Due to its frequency and persistently high mortality, colorectal cancer represents a major public health problem. The use of adjuvant chemotherapy has improved prognosis in stage III disease, but much work remains to be done in optimizing adjuvant treatment, including refinement of ability to predict disease course and response to chemotherapy. The FOLFOX4 regimen is now considered standard treatment for stage III disease. Combinations of irinotecan and 5-fluorouracil (5-FU) have not proven to be more effective than 5-FU/folinic acid (FA). Oral fluoropyrimidines (eg, capecitabine, UFT + FA) now offer an alternative to intravenous 5-FU. Adjuvant chemotherapy for stage II colorectal cancer is more controversial. Use of adjuvant chemotherapy does not appear to be justified in patients with no particular risk factors (T3N0 with no poor prognosis factor). In contrast, the risk:benefit ratio in patients with one or more poor prognostic factors (T4 tumor, occlusion or perforation, poorly differentiated tumor, vascular invasion, or
Extended-field irradiation and intracavitary brachytherapy combined with cisplatin and amifostine for cervical cancer with positive para-aortic or high common iliac lymph nodes: results of arm II of Radiation Therapy Oncology Group (RTOG) 0116. [2018]Radiation Therapy Oncology Group (RTOG) 0116 was designed to test the ability of amifostine (Ethyol; MedImmune LLC, Gaithersburg, MD), a cytoprotective agent, to reduce the acute toxicity of combined therapy with extended-field irradiation, brachytherapy, and cisplatin chemotherapy in patients with cervical cancer with para-aortic or high common iliac disease. This report presents the results of part 2.
Mini profile of potential anticancer properties of propofol. [2022]Propofol (2, 6-diisopropylphenol) is an intravenous sedative-hypnotic agent administered to induce and maintain anesthesia. It has been recently revealed that propofol has anticancer properties including direct and indirect suppression of the viability and proliferation of cancer cells by promoting apoptosis in some cancer cell lines.
Randomized clinical trial of adjuvant chemotherapy with S-1 versus gemcitabine after pancreatic cancer resection. [2022]Randomized studies of adjuvant chemotherapy using gemcitabine suggest a survival benefit after resection of pancreatic cancer. S-1 has also been shown to prolong survival in patients with unresectable pancreatic cancer. This study compared the effects of adjuvant chemotherapy with S-1 or gemcitabine after resection of pancreatic cancer in a randomized trial.
Survival after primary breast cancer surgery following propofol or sevoflurane general anesthesia-A retrospective, multicenter, database analysis of 6305 Swedish patients. [2021]Retrospective studies indicate that the choice of anesthetic can affect long-term cancer survival. Propofol seems to have an advantage over sevoflurane. However, this is questioned for breast cancer. We gathered a large cohort of breast cancer surgery patients from seven Swedish hospitals and hypothesized that general anesthesia with propofol would be superior to sevoflurane anesthesia regarding long-term breast cancer survival.
Association Between Anesthesia Delivered During Tumor Resection and Cancer Survival: a Systematic Review of a Mixed Picture with Constant Themes. [2022]Surgery is required for cure of most solid tumors, and general anesthesia is required for most cancer surgery. The vast majority of cancer surgery is facilitated by general anesthesia using volatile inhalational agents such as isoflurane and sevoflurane. Only recently have the immunologic and oncologic effect of inhalational agents, and their alternative, propofol-based total intravenous anesthesia (TIVA), come under investigation.
Effect of equipotent doses of propofol and sevoflurane on endoplasmic reticulum stress during breast cancer surgery. [2023]Numerous studies suggest that intravenous propofol is superior to inhaled volatile anesthetic. This study compared the changes in the endoplasmic reticulum (ER) stress of cancer cells and lymphocytes after propofol- and sevoflurane-based anesthesia during breast cancer surgery.
General Anesthetics in Cancer Surgery: Can Anesthesiologists Help the Patient with More than a Safe Sleep. [2022]Most patients suffering from neoplastic diseases will at some point during their illness be approached surgically. Surgery itself may be unfortunately responsible for tumor proliferation and metastatic spread. With the perioperative period increasingly becoming a focus of research in anesthesia, anesthesiologists have looked at the chance to influence cancer progression based on their choice of anesthesia regimen and strategy. Many anesthetic agents have been investigated for their potential impact on the course of cancer disease. There is an abundance of retrospective studies and very few prospective ones that tackled this issue. The aim of this article is to review the current state of the evidence on general anesthesia involving volatile and intravenous agents as substrates, focusing on halogenated inhalational agents and propofol, to guide clinical decision making in assessments of the best practice for perioperative management of cancer surgery.