Individual Following in Anal Cancer With PET/CT

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Brief Title

Individual Following in Anal Cancer With PET/CT

Official Title

Individual Following in Anal Cancer With PET/CT

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.
    


Study Type

Observational


Primary Outcome

time of disease-free survival

Secondary Outcome

 best metabolic response measurement variable: SUVmax

Condition

Anal Cancer

Intervention

anal cancer


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

110

Start Date

November 2014

Completion Date

October 2021

Primary Completion Date

September 2021

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

LOVERA Christine, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT02697084

Organization ID

2014/54


Responsible Party

Sponsor

Study Sponsor

Centre Antoine Lacassagne


Study Sponsor

LOVERA Christine, Study Director, Centre Antoine Lacassagne


Verification Date

July 2021