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

TROG 99.02 A prospective single arm non randomised study of concurrent radiation and chemotherapy for the organ conserving treatment of early anal canal cancer assessed by colostomy free survival and late toxicity.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000188033

Acronym

TROG 99.02

Enrollment

Registered

2010-03-02

Start date

1999-03-02

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Anal canal cancer is generally sensitive to both radiation and chemotherapy and these two treatments given together is now the "gold standard treatment for most early anal canal cancers. Our study was designed to see if we could maintain the generally good cure rates using less extensive and lower doses of radiation and chemotherapy than have been given in some centres. We also looked to see if the less intensive treatment would result in a lower risk of serious side effects for the patient.

Interventions

concurrent radiation and chemotherapy over a total of 7 weeks 3 days. Radiation:50.4 Gy given in split course - initial phase 36 Gy in 18 fractions to primary +/- perirectal nodes followed after 2 week gap with 14.4 Gy in 8 fractions to primary alone. Chemotherapy: 5FU 800mg/m2/day (maximum 1.5gm a day) given by intravenous infusion (IV) Days 1-4 and Days 43-46 and Mitomycin C 10mg/m2 (maximum 15mg) by intravenous (IV) bolus Day 1 only.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

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

Outcome results