# ACT II

Source: https://onco.cc/trials/act-ii/  
OnCo record `act-ii` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

ACT II, the largest anal cancer trial, confirmed mitomycin-fluorouracil chemoradiation as the standard, showed that swapping in cisplatin or adding maintenance chemotherapy gave nothing, and taught doctors to wait six months before judging response.

## Summary

ACT II randomised 940 patients with anal squamous cell carcinoma in a two-by-two design to mitomycin or cisplatin with fluorouracil during 50.4 Gy radiotherapy, and to two cycles of maintenance cisplatin-fluorouracil or none. Complete response at 26 weeks was about 90 percent in both chemotherapy arms and progression-free survival did not differ with maintenance (James and colleagues, Lancet Oncology 2013). The trial also showed that responses continue for months after chemoradiation, so assessment should wait 26 weeks before surgery is considered.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-17
- Tags: radiation-wave4
- Phase: 3
- Setting: Squamous cell carcinoma of the anus: mitomycin versus cisplatin with fluorouracil chemoradiation, and maintenance chemotherapy versus none
- Sponsor: Cancer Research UK
- Enrolled: 940
- Result: Complete response about 90% with either mitomycin or cisplatin; no benefit from maintenance chemotherapy.

## Sources

- ISRCTN26715889: https://www.isrctn.com/ISRCTN26715889
- Lancet Oncology 2013: https://doi.org/10.1016/S1470-2045(13)70086-X

## Connected records

- cancers: [Anal cancer (squamous cell carcinoma)](https://onco.cc/cancers/anal/)
- technologies: [IMRT / IGRT (modern external beam)](https://onco.cc/technologies/imrt-igrt/), [Radiosensitisers](https://onco.cc/technologies/radiosensitisers/)
- drugs: [Cisplatin](https://onco.cc/drugs/cisplatin/), [Fluorouracil (5-FU)](https://onco.cc/drugs/fluorouracil/), [Mitomycin C](https://onco.cc/drugs/mitomycin/)
- terms: [Chemoradiation (chemoradiotherapy, CRT)](https://onco.cc/terms/chemoradiation/)

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