Health TrialsbyHealthPanel

Inguinal Node Sparing Radiotherapy For Patients With Early Stage Anal Cancer

ConditionAnal Canal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAHS Cancer Control Alberta

About this trial

The purpose of this study is to see whether avoiding preventative radiation to the groin in patients with normal sentinel node biopsy and PET-CT, is at least as effective treating cancer as giving preventative radiation to the groin for patients with anal canal cancer.

The investigators also want to know if avoiding radiation to the groin will cause fewer side effects and better quality of life

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants capable of giving informed consent.

Patients must be 18 years of age or older.

Patient should have histologically proven primary squamous cell carcinoma.

Patients must have early AC, Stage T1-3 N0 M0.

Disqualifiers

T1N0 patients going for primary surgery

Prior radiation therapy to the pelvis.

Pregnancy or lactation.

Prior surgical treatment for anal cancer other than biopsy.

Trial design

Design model

Single group

Treatments tested in this trial

  • chemo-radiation treatment

    Radiation

    Radiotherapy (RT) with concurrent 5-fluorouracil and mitomycin-C (5FU/MMC) combination is the treatment of choice for non-metastatic locally advanced anal squam

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: chemo-radiation treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of inguinal lymph node recurrence

The primary end point is measured by PET/CT imaging at 3 months post treatment and, then CT scan of chest, abdomen and pelvis every 3 months for 2 years and then every 6 months for another year.

Time frame
Total duration of follow up is 36 months
2

Disease free survival (DFS)

Time between enrollment and date of relapse (radiographic or clinical progression) leading to change in therapy for recurrent disease or death due to any cause.

Time frame
36 months

Secondary outcomes

1

Health related Quality of Life (EORTC QLQ-C30)

Evaluation will be done using EORTC QLQ-C30 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30). Assessed at baseline (before starting CRT) and, at 3 months, 12 months, 24 months and 36 months after completion of treatment.

Time frame
36 months
2

Health related Quality of Life (EORTC QLQ-AN27)

Evaluation will be done using EORTC QLQ-AN27, the supplementary module specific for anal cancer. Assessed at baseline (before starting CRT) and, at 3 months, 12 months, 24 months and 36 months after completion of treatment.

Time frame
36 months
3

Health related Quality of Life (IIEF)

Evaluation will be done using International Index of Erectile Function (IIEF) for Men. Assessed at baseline (before starting CRT) and, at 3 months, 12 months, 24 months and 36 months after completion of treatment.

Time frame
36 months
4

Health related Quality of Life (FSFI)

Evaluation will be done using Female Sexual Function Index (FSFI). Assessed at baseline (before starting CRT) and, at 3 months, 12 months, 24 months and 36 months after completion of treatment.

Time frame
36 months

Other outcomes

1

Relationship between radiotherapy treatment planning variables and acute toxicity.

We will be collecting information related to treatment plans for each patient such as total irradiated volume, dose to OARs, integral dose and will evaluate any association between these factors and toxicity.

Time frame
36 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AHS Cancer Control Alberta

Lead sponsor

Source ClinicalTrials.gov
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