TROG 99.02 Concurent radiation and chemotherapy for the organ conserving treatment of early anal canal cancer

Phase 2

Completed

• Conditions: anal canal cancer; Cancer - Bowel - Anal

• Registration Number: ACTRN12610000188033
• Lead Sponsor: Trans-Tasman Radiation Oncology Group Inc (TROG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

squamous cell cancer including basaloid variant
Stage T1 and T2 <4cm, N0 or N1, M0
Performance status WHO grade 0,1,2
adequate bone marrow, liver and renal function

Exclusion Criteria

anal tumours of other histology eg adenocarcinoma
anal margin tumours
patients presenting with recurrent disease after prior excision
history of ischaemic heart disease where 5FU considered a cardiac hazard
impaired control of anal shpincter
known immunosuppression eg HIV +ve or AIDS
pregnant or lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To test the hypothesis that this chemoradiation schedule can acheive a 5 year colostomy free survival in 85% of patients with less than 10% Grade 3 and 4 Radiation Therapy Oncology Group (RTOG) late toxicity. <br><br>Colostomy free survival is assessed by clinical assessment. Late toxicity is scored using the Radiation Therapy Oncology Group /European Organisation for Research and Treatment of Cancer (RTOG/EORTC) Late Radiation Morbidity Scoring Scheme[Follow up schedule for clinical assessment is 1,2,3, 6 months after completion of treatment and then 3 monthly for the rest of the first 2 years and subsequently 4 monthly during the 3rd year, 6 monthly during years 4 and 5. <br><br>Late toxicity is scored by physician scored toxicity forms at 6 months post completion of treatment and and then 3 monthly for the rest of the first 2 years and subsequently 4 monthly during the 3rd year, 6 monthly during years 4 and 5]