Hypoxia-guided Radiotherapy With Cisplatin-etoposide in Stage I-III : Small Cell Lung Cancer(SCLC) — HX4 in SCLC  

Small Cell Lung Cancer (SCLC) Clinical Trial

Official title: Individualized Hypoxia-guided Radiotherapy Combined With Standard Cisplatin-etoposide in Stage I-III SCLC

Status Withdrawn

Clinical Trial Summary

Since radiation dose escalation to a large volume of tumour inevitably will induce higher toxicity than is currently the case, efforts must be made to limit the volume of tissue irradiated. Moreover, the irradiation of larger tumour volumes leads to a lower achievable tumour dose when keeping the normal tissue doses constant. Central is thus the question whether it would be possible to limit the volume of tumour to be boosted by selectively escalating the radiation dose to specific disease sites which are theoretically more prone to relapse.

Clinical Trial Description

Hypoxic imaging with PET scans seems attractive for this purpose as hypoxia is associated with resistance for radiotherapy and approximately 70 % of SCLC are severely hypoxic at diagnosis[2].

We hypothesize that it might be possible to use a selective boost in these patients to tumor areas which are still hypoxic at the end of the standard chemo-radiotherapy to a dose of 45 Gy in 30 fractions in 3 weeks.

This way all SCLC (small cell lung cancer) patients can receive a safe, but higher dose of radiotherapy to the whole tumor volume, while the most resistant areas receive the highest possible dose.

This is a hypothesis generating trial designed to deliver at least the current standard treatment to malignant tissue while defining patient selection criteria for future study. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Small Cell Lung Cancer (SCLC)
• Small Cell Lung Carcinoma

• NCT number: NCT01210131
• Study type: Interventional
• Source: Maastricht Radiation Oncology
• Status: Withdrawn
• Phase: N/A
• Start date: July 2013
• Completion date: August 2014