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Individual Following in Anal Cancer With PET/CT (IFACT)

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ClinicalTrials.gov Identifier: NCT02697084
Recruitment Status : Recruiting
First Posted : March 3, 2016
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Antoine Lacassagne

Brief Summary:

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.


Condition or disease Intervention/treatment
Anal Cancer Other: anal cancer

Detailed Description:
Post-treatment 18-FDG PET scan at 2 months can prove useful to predict locoregional or metastatic recurrence in patients treated by radiochemotherapy or radiotherapy in the anal canal cancer setting. There appear to be an FDG intensity variable and a metabolic response criterion enabling establishment of two groups of patients: low recurrence risk versus high recurrence risk at 2 years.

Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Individual Following in Anal Cancer With PET/CT
Study Start Date : November 2014
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anal Cancer


Intervention Details:
  • Other: anal cancer
    Anal cancer patients with TEP TDM


Primary Outcome Measures :
  1. time of disease-free survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. best metabolic response measurement variable: SUVmax [ Time Frame: 3 years ]
  2. best metabolic response measurement variable: SUVmean [ Time Frame: 3 years ]
  3. best metabolic response measurement variable: SUL peak [ Time Frame: 3 years ]
  4. best metabolic response measurement variable: Metabolic Total Volume (MTV) [ Time Frame: 3 years ]
  5. best metabolic response measurement variable: Total Lesion Glycolysis (TLG) [ Time Frame: 3 years ]
  6. best treatment response criterion: SUV or metabolic volume threshold [ Time Frame: 3 years ]
  7. best treatment response criterion: ratio (SUV or metabolic volume) [ Time Frame: 3 years ]
  8. best treatment response criterion: complete or partial metabolic response according to EORTC or PERCIST criteria [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Canal anal cancer
Criteria

Inclusion Criteria:

  • Consecutive inclusion of incident cases of anal canal cancer between November 2014 and May 2018. These patients are volunteers and have signed informed consent.

Exclusion Criteria:

  • Presence of a nother cancer and specific treatment (chemotherapy, radiotherapy). Follow-up impossible during two years or more.

Refusal to submit to initial or post-treatment PET/CT.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02697084


Locations
France
Centre Antoine Lacassagne Recruiting
Nice, France, 06000
Contact: FRANCOIS Eric, MD    +33492031163    eric.francois@nice.unicancer.fr   
Sponsors and Collaborators
Centre Antoine Lacassagne
Investigators
Study Director: LOVERA Christine Centre Antoine Lacassagne

Additional Information:
Responsible Party: Centre Antoine Lacassagne
ClinicalTrials.gov Identifier: NCT02697084     History of Changes
Other Study ID Numbers: 2014/54
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Anus Diseases
Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases