RADIOLOGIC

• Research type

  Research Study

• Full title

  Definitive Chemoradiotherapy with the Addition of Lapatinib in Inoperable ,Locally Advanced Oesophageal and OGJ Adenocarcinoma - A Phase I study

• IRAS ID

  92719

• Contact name

  Sheela Rao

• Sponsor organisation

  Clinical Research and Development, Royal Marsden NHS Foundation Trust

• Eudract number

  2012-000315-88

• ISRCTN Number

  not issued

• Research summary

  In 2008, over 8 thousand (8173) people were diagnosed with oesophageal cancer in the UK and 7606 people died from this condition in the same year. This high mortality rate is due to the poor prognosis of oesophageal cancer, with less than 10% patients surviving 5 years after having been diagnosed with it. The United Kingdom has the highest age-standardized incidence of oesophageal cancer in Europe.Chemoradiotherapy is an important treatment strategy for locally advanced inoperable or unresectable disease. Unfortunately loco-regional disease persistence or subsequent failure is still high and attempts of treatment intensification, either in the chemotherapy or radiotherapy components have been restricted by unacceptable toxicity. At the same time, the radiotherapy dose is an independent predictor of a pathological complete response and the addition of chemotherapy has further impact on this aspect of outcome. Improvements in local treatment delivery are therefore needed to facilitate dose escalation, as justified by radiobiological consideration and to minimise toxicity.This is a single centre, phase 1 study aiming to establish the maximum tolerated dose of lapatinib given in conjunction with standard capecitabine, cisplatin and conventionally fractionated standard dose radiotherapy, as part of the chemoradiotherapy phase following standard induction chemotherapy in patients with inoperable, locally advanced adenocarcinoma of the oesophagus or oesophagogastric junction. Safety and tolerability of lapatinib will be assessed and a maximum of 18 patients will be enrolled into this phase I study.

• REC name

  London - Central Research Ethics Committee

• REC reference

  12/LO/0843

• Date of REC Opinion

  8 Jun 2012

• REC opinion

  Favourable Opinion