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Anus Neoplasms clinical trials

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NCT ID: NCT02697084 Recruiting - Anal Cancer Clinical Trials

Individual Following in Anal Cancer With PET/CT

IFACT
Start date: November 2014
Phase:
Study type: Observational

Anal canal cancer is a relatively rare disease, representing 1.2% of digestive cancers and 6% of anorectal cancers. Incidence is less than 1/100 000 of the general population. However, the incidence has increased considerably over the past three decades. The main risk factors are HPV infections and smoking. Initial treatment comprises radiochemotherapy or radiotherapy alone, according to the patient's tumor stage and tolerance of chemotherapy. The choice of the most appropriate treatment strategy will condition the patient's prognosis. Consequently, early assessment of the initial extension of the tumor, its therapeutic response and relapses constitute determining factors in the management of the disease Despite the good results obtained, persistent disease is observed in 30% of cases and abdominal-pelvic salvage amputation can then prove effective in cases of local or loco-regional relapse. The great majority of relapses occur within 2 years after treatment. Reported prognostic survival factors are the T stage, size inferior or superior to 4 cm and inguinal or pelvic lymph node involvement. The rules for follow-up are not substantiated by high levels of proof. Follow-up focuses principally on the clinical examination although the type and frequency of the paraclinical examinations are not backed by any consensus.

NCT ID: NCT02628067 Recruiting - Cervical Cancer Clinical Trials

Study of Pembrolizumab (MK-3475) in Participants With Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)

Start date: December 18, 2015
Phase: Phase 2
Study type: Interventional

In this study, participants with multiple types of advanced (unresectable and/or metastatic) solid tumors who have progressed on standard of care therapy will be treated with pembrolizumab (MK-3475).

NCT ID: NCT02560298 Active, not recruiting - Clinical trials for Anal Squamous Cell Carcinoma

Cisplatin and Fluorouracil Compared With Carboplatin and Paclitaxel in Treating Patients With Inoperable Locally Recurrent or Metastatic Anal Cancer

InterAACT
Start date: August 23, 2016
Phase: Phase 2
Study type: Interventional

This randomized phase II trial studies how well cisplatin and fluorouracil work compared with carboplatin and paclitaxel in treating patients with anal cancer that cannot be removed by surgery, has come back at or near the same place as the primary tumor, or spread to other places in the body. Drugs used in chemotherapy, such as cisplatin, fluorouracil, carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether cisplatin and fluorouracil are more effective than carboplatin and paclitaxel in treating anal cancer.

NCT ID: NCT02546973 Active, not recruiting - Anal Cancer Clinical Trials

Quality of Life in Patients With Anal Cancer

ANCA
Start date: September 2015
Phase:
Study type: Observational

A national study of a three year cohort consisting of all patients diagnosed with anal cancer in 2011- 2013 with data retrieval from three national registries: Cancer Registry, Patient registry and Cause of Death Registry all within the Swedish Board of Health and Welfare. All out- and inpatient visits with diagnoses, admission dates and discharge dates will be requested including. Patient documentation from the concerned hospitals will be collected and data on the details of the treatment collected retrospectively in a standardised fashion using a clinical record form. Comorbidity will be calculated using data from the Patient Registry using all main and co-diagnoses 2 years prior and then at least two years after treatment cessation. Detailed questionnaires will be sent out once at 2-3 years and a second time at about 6 years after index treatment.

NCT ID: NCT02526953 Enrolling by invitation - Neoplasms Clinical Trials

Efficacy Study of Chemoradiotherapy With or Without Paclitaxel in Squamous-cell Anal Carcinoma Patients

Start date: January 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether the combination of paclitaxel, capecitabine, mitomycin and intensity-modulated radiotherapy is more effective than the standard combination of capecitabine, mitomycin and intensity-modulated radiotherapy (IMRT) in patients with squamous-cell anal cancer.

NCT ID: NCT02503111 Terminated - Anal Cancer Clinical Trials

The HPV-SAVE Study Team: HPV Screening and Vaccine Evaluation in Men Who Have Sex With Men

HPV-SAVE
Start date: November 2015
Phase: N/A
Study type: Interventional

Human papillomavirus (HPV) is the most common sexually transmitted infection worldwide. Infection by certain high-risk oncogenic types of HPV (HR-HPV) is the major cause of several cancers in men, notably squamous cell carcinoma (SCC) of the anal canal. Rates of anal infection with these HR-HPV strains and the resultant high-grade anal dysplasia and anal cancer are much higher in men who have sex with men (MSM) than in the general population. Co-infection with human immunodeficiency virus (HIV) further amplifies this burden, making the rates of anal SCC in HIV-positive MSM higher than the historic rates of cervical cancer prior to the adoption of routine cervical cytology screening. Despite these alarming statistics, there are no established protocols for optimal screening and treatment of anal HPV and cancer precursors, nor has there been any widespread rollout of organized screening programs anywhere in Canada. Further, not only does HPV directly cause significant disease in these men, but there is growing epidemiologic evidence that HPV infection may enhance sexual transmission of HIV. These significant knowledge gaps translate into fundamental deficiencies in care for HIV-positive MSM. The HPV Screening and Vaccine Evaluation in MSM (HPV-SAVE) study team will recruit a large group of MSM from various Ontario and Vancouver clinics, in order to carry out a number of different studies. The HPV-SAVE team brings together community and internationally-recognized experts in HPV and HIV disease and mucosal immunology, to better define the optimal approaches for primary and secondary prevention and treatment of HPV-associated anal disease among HIV-positive MSM, and to explore biological mechanistic evidence regarding the potential role of HPV as a co-factor for HIV transmission. This will yield critical information which can lead to improvement in the health of MSM, and will provide a foundation on which to build further, large-scale screening and treatment trials on a national level. The primary aim of the current study is to systematically compare ablative therapy versus intensive observation alone (also known as 'watchful waiting') in outcomes relating to high-grade anal dysplasia.

NCT ID: NCT02489422 Completed - Depression Clinical Trials

Programs To Support You During Chemotherapy

PRO-YOU
Start date: August 2016
Phase: N/A
Study type: Interventional

This randomized pilot trial studies how well two supportive programs work for improving fatigue and depressive symptoms in patients with GI undergoing chemotherapy. Possible mediators such as psychological stress, circadian disruption, and inflammation, will also be explored.

NCT ID: NCT02437851 Active, not recruiting - HIV Infection Clinical Trials

Surgery in Treating Patients With Early Stage Anal Canal or Perianal Cancer and HIV Infection

Start date: April 2015
Phase: Phase 2
Study type: Interventional

This phase II trial studies surgery in treating patients with anal canal or perianal cancer that is small and has not spread deeply into the tissues and human immunodeficiency virus (HIV) infection. Local surgery may be a safer treatment with fewer side effects than bigger surgery or radiation and chemotherapy.

NCT ID: NCT02407561 Terminated - Clinical trials for Rectal Adenocarcinoma

Prospective Validation Study for the Proprietary Rectal and Anal Cancer Protein Expression Assays

Start date: February 2015
Phase: N/A
Study type: Observational

Patients with locally advanced rectal and esophageal carcinomas typically undergo neoadjuvant chemoradiation therapy prior to surgical resection. While response rates to this treatment differ among these three cancers, generally 20-25% of patients exhibit minimal or no response to preoperative chemoradiation therapy while 20-30% exhibit a complete pathologic response, and the remainder receiving a partial response. This will be a multi-center study of patients with newly diagnosed rectal adenocarcinoma, or anal squamous cell carcinoma (SCC) who will undergo neoadjuvant chemoradiation prior to surgery. The tumor from these patients will be tested to determine whether response to neoadjuvant chemoradiation can be accurately predicted.

NCT ID: NCT02402842 Completed - Clinical trials for Anal Canal Carcinoma

Clinical and Biological Interest of Taxanes in Advanced Squamous Cell Anal Carcinoma

Epitopes-HPV02
Start date: September 2014
Phase: Phase 2
Study type: Interventional

Squamous cell carcinoma of the anal canal (SCCA) is a rare disease and mostly diagnosed at an early stage. After standard concurrent chemoradiation (CRT) with mitomycin (MMC) and 5-fluorouracil (5FU), the disease will recur in 20% of patients. After treatment failure (including salvage surgery), cisplatin-5FU combination is the standard option but complete response is a rare event and the prognosis remains poor with most patients' death occurring in the first 12 months. Decision making for physicians in this setting is only based on retrospective studies or small phase II clinical trials including less than 20 patients. Hence, no efficient standard of care is currently available for relapsing SCCA patients who are currently treated with a palliative intent. Between 2007 and 2013, 8 consecutive patients with advanced recurrent SCCA after CRT were treated with DCF regimen (docetaxel, cisplatin and 5-fluorouracil) in the Regional Cancer Institute of Franche Comté. After a median follow-up of 41 months, 4 patients (50%) achieved a complete response. Three patients underwent surgery of all involved metastatic sites. A pathological complete response was observed for all of them including in metastases occurring in irradiated fields, suggesting that taxane-based chemotherapy might be an effective strategy to circumvent resistance to radiotherapy (a preliminary cohort of 8 patients was published (Kim S et al Annals of oncology 2013). Furthermore, all complete responders were HPV 16, and high levels of specific T cell responses against Human Papillomavirus (HPV) HPV16-derived E6/E7 and telomerase were detected in 50% of complete responders suggesting the potential restoration of cancer immunosurveillance by this regimen. Then, the Epitopes-HPV02 multicenter phase II study will aim to confirm the new role of taxane-based chemotherapy in SCCA patients.