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OpenTrials
Completed

NCT Number: NCT02697084

Individual Following in Anal Cancer With PET/CT

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

anal cancer

Other

Anal cancer patients with TEP TDM

Primary outcomes

  1. time of disease-free survival

    Time frame: 3 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Antoine Lacassagne

Other

Registry information

Acronym: IFACT

Important dates

Study start
2014
Primary completion
2024
Study completion
2024
First posted
Mar 3, 2016
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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