InterAACT was the first randomised trial ever run in advanced anal cancer; the two chemotherapy pairs shrank tumours equally often, but carboplatin with paclitaxel caused far fewer serious side effects and patients on it lived longer, so it became the standard chemotherapy backbone.
InterAACT was an international randomised phase 2 trial of the International Rare Cancers Initiative, led from the Royal Marsden with ECOG-ACRIN, AGITG and EORTC partners, in 91 patients with chemotherapy-naive advanced anal squamous cell carcinoma randomised to cisplatin plus fluorouracil or carboplatin plus weekly paclitaxel. The primary endpoint was best overall response rate by 24 weeks.
Response rates were the same (57 against 59 percent), but serious adverse events were more frequent with cisplatin-fluorouracil (62 against 36 percent), median progression-free survival was 5.7 against 8.1 months and median overall survival 12.3 against 20 months (hazard ratio 2.00 for cisplatin-fluorouracil). Carboplatin-paclitaxel became the reference regimen and the chemotherapy backbone of POD1UM-303, which is how the corpus's metastatic anal cancer page cites it.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
91 randomised.
95% CI 42.1 to 74.4 · 95% CI 39.4 to 73.7
Source95% CI 12.7 to not reached · 95% CI 9.2 to 17.7
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Best overall response rate by 24 weeksprimary | Carboplatin + weekly paclitaxel | 45 | 59% | - | - | link |
| Cisplatin + fluorouracil | 46 | 57% | ||||
| Overall survival | Carboplatin + weekly paclitaxel | 45 | 20 months | 2 (1.15 to 3.47) | 0.014 | link |
| Cisplatin + fluorouracil | 46 | 12.3 months | ||||
| Progression-free survival | Carboplatin + weekly paclitaxel | 45 | 8.1 months | - | - | link |
| Cisplatin + fluorouracil | 46 | 5.7 months | ||||
| Serious adverse events | Carboplatin + weekly paclitaxel | 45 | 36% | - | 0.016 | link |
| Cisplatin + fluorouracil | 46 | 62% |
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares Metastatic and recurrent anal squamous cell carcinoma, Anal cancer (squamous cell carcinoma), Paclitaxel / nab-paclitaxel, Carboplatin and the tag soc-trials.
Shares ECOG-ACRIN Cancer Research Group, Paclitaxel / nab-paclitaxel, Cisplatin, Cytotoxic chemotherapy and the tag soc-trials.
Shares Metastatic and recurrent anal squamous cell carcinoma, Anal cancer (squamous cell carcinoma) and the tag soc-trials.
Shares Cisplatin, Carboplatin, Cytotoxic chemotherapy and the tag soc-trials.
Shares Cisplatin, Carboplatin, Cytotoxic chemotherapy and the tag soc-trials.
Shares Paclitaxel / nab-paclitaxel, Cisplatin, Cytotoxic chemotherapy and the tag soc-trials.
Shares Fluorouracil (5-FU), Cytotoxic chemotherapy and the tag soc-trials.
Shares Anal cancer (squamous cell carcinoma), Fluorouracil (5-FU) and the tag soc-trials.
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/