# TROG 05.01 (chemotherapy added to radiotherapy after surgery for high-risk skin squamous cell carcinoma)

Source: https://onco.cc/trials/trog-05-01/  
OnCo record `trog-05-01` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Adding chemotherapy to the radiotherapy given after surgery for the most dangerous skin squamous cancers did not help. What the trial did show is how well surgery and radiotherapy already work: more than four in five of these high-risk cancers were still controlled five years later.

## Summary

Cutaneous squamous cell carcinoma of the head and neck with involved nodes or aggressive local features is the form of keratinocyte cancer that kills people, and the head and neck oncology habit of adding chemotherapy to postoperative radiotherapy was being carried across to it without evidence. TROG 05.01 randomised 321 patients, 310 of whom started their allocated treatment, to radiotherapy alone or radiotherapy with weekly carboplatin. Seventy-seven per cent had high-risk nodal disease, 19 per cent high-risk primary or in-transit disease and 4 per cent both. The median radiotherapy dose was 60 Gy and 84 per cent of the chemoradiotherapy arm completed six cycles of carboplatin.

At a median follow-up of 60 months, freedom from locoregional relapse at two and five years was 88 and 83 per cent with radiotherapy alone and 89 and 87 per cent with chemoradiotherapy, a hazard ratio of 0.84 (95 per cent confidence interval 0.46 to 1.55, p=0.58). There was no difference in disease-free or overall survival. Carboplatin did not worsen the radiation toxicity, and grade 3 or 4 late toxicity was infrequent in both arms.

Two readings follow. The negative one is that carboplatin adds nothing and should not be given. The positive one is the control arm: surgery followed by radiotherapy controlled 83 per cent of these tumours locally and regionally at five years, and the first site of failure was locoregional rather than distant in all but 7 per cent. That is the benchmark the adjuvant immunotherapy trials had to beat, and it is why C-POST was designed with disease-free survival rather than local control as its endpoint.

## Fields

- Kind: Trial
- Status: negative
- Last checked: 2026-09-25
- Also known as: TROG 05.01; POST trial; Trans Tasman Radiation Oncology Group 05.01
- Registry id: NCT00193895
- Phase: 3
- Setting: High-risk cutaneous squamous cell carcinoma of the head and neck after resection of gross disease: postoperative radiotherapy of 60 to 66 Gy over six to six and a half weeks, with or without weekly carboplatin at an area under the curve of 2, with freedom from locoregional relapse as the primary endpoint
- Sponsor: Trans Tasman Radiation Oncology Group
- Enrolled: 321
- Result: Freedom from locoregional relapse at five years 87 per cent with chemoradiotherapy against 83 per cent with radiotherapy alone (hazard ratio 0.84, 95 per cent confidence interval 0.46 to 1.55, p=0.58), with no difference in disease-free or overall survival.
- Outcomes: Freedom from locoregional relapse at 5 years: Postoperative radiotherapy with weekly carboplatin 87% vs Postoperative radiotherapy alone 83%, HR 0.84; Freedom from locoregional relapse at 2 years: Postoperative radiotherapy with weekly carboplatin 89% vs Postoperative radiotherapy alone 88%
- Replication: No second randomised trial of chemoradiotherapy in cutaneous squamous cell carcinoma has been run. The adjuvant question moved to immunotherapy instead, and C-POST answered it.

## Sources

- ClinicalTrials.gov NCT00193895: https://clinicaltrials.gov/study/NCT00193895
- Primary report (Journal of Clinical Oncology 2018): https://doi.org/10.1200/JCO.2017.77.0941
- Primary report on PubMed: https://pubmed.ncbi.nlm.nih.gov/29537906/

## Connected records

- cancers: [Cutaneous squamous cell carcinoma](https://onco.cc/cancers/cutaneous-scc/), [Skin cancer (all types)](https://onco.cc/cancers/skin-cancer/)
- technologies: [IMRT / IGRT (modern external beam)](https://onco.cc/technologies/imrt-igrt/)
- drugs: [Carboplatin](https://onco.cc/drugs/carboplatin/)
- terms: [Perineural invasion (PNI)](https://onco.cc/terms/perineural-invasion/), [Radiotherapy for skin cancer](https://onco.cc/terms/radiotherapy-for-skin-cancer/)
- trials: [C-POST (cemiplimab after surgery and radiotherapy for high-risk skin squamous cell carcinoma)](https://onco.cc/trials/c-post/), [EMPOWER-CSCC-1](https://onco.cc/trials/empower-cscc-1/), [Surgery against radiotherapy for basal cell carcinoma of the face](https://onco.cc/trials/avril-surgery-versus-radiotherapy-bcc/)

---
JSON: https://onco.cc/api/v1/entities/trog-05-01.json