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Individual Following in Anal Cancer With PET/CT

Individual Following in Anal Cancer With PET/CT

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02697084
Acronym
IFACT
Enrollment
110
Registered
2016-03-03
Start date
2014-11-01
Completion date
2024-09-01
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Cancer

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.

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.

Interventions

OTHERanal cancer

Anal cancer patients with TEP TDM

Sponsors

Centre Antoine Lacassagne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
time of disease-free survival3 years

Secondary

MeasureTime frame
best metabolic response measurement variable: SUVmax3 years
best metabolic response measurement variable: SUVmean3 years
best metabolic response measurement variable: SUL peak3 years
best metabolic response measurement variable: Metabolic Total Volume (MTV)3 years
best metabolic response measurement variable: Total Lesion Glycolysis (TLG)3 years
best treatment response criterion: SUV or metabolic volume threshold3 years
best treatment response criterion: ratio (SUV or metabolic volume)3 years
best treatment response criterion: complete or partial metabolic response according to EORTC or PERCIST criteria3 years

Countries

France

Contacts

STUDY_DIRECTORLOVERA Christine

Centre Antoine Lacassagne

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026