Proton therapy for reducing side effects in lung cancer treatment
Proton Therapy to Reduce Acute Normal Tissue Toxicity in Locally Advanced Non-small-cell Lung Cancer
This study is testing whether proton therapy can help people with advanced lung cancer experience fewer severe side effects from radiation treatment compared to traditional photon therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Technische Universität Dresden Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Dresden) |
| Trial ID | NCT02731001 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of proton therapy versus photon therapy in reducing acute radiation-induced side effects, such as pneumonitis and esophagitis, in patients with locally advanced non-small cell lung cancer (NSCLC). Patients will be randomly assigned to receive either intensity-modulated radiotherapy with photons or proton therapy, both combined with chemotherapy. The primary goal is to demonstrate a significant reduction in the incidence of severe side effects associated with radiation therapy. Secondary objectives include assessing quality of life, loco-regional control, survival rates, and late radiation-induced side effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with locally advanced NSCLC who are medically suited for primary radiochemotherapy.
Not a fit: Patients with early-stage tumors suitable for stereotactic radiotherapy or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of severe side effects from radiation therapy, improving the quality of life for lung cancer patients.
How similar studies have performed: Previous studies have shown promising results with proton therapy in reducing side effects, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * NSCLC (confirmed by cytology or histology) staged UICC IIIA or IIIB or UICC II if the patient declines surgery * no distant metastases (M1) * patient' age between 18 and 70 years * Patient medically suited for primary radiochemotherapy with curative intent * signed declaration of informed consent * adequate compliance for treatment and clinical follow up * adequate contraception during and after therapy if indicated Exclusion Criteria: * Participation in other interventional trial * T1 or T2 N0 tumours that are candidates for stereotactic radiotherapy * relevant neurological or psychiatric disorders that hinder treatment, follow-up or understanding of the procedures * pregnant or breastfeeding women * prior thoracic radiotherapy * history of other malignancies during the last 5 years (exceptions can be made for tumours with excellent outcome) * weight loss greater than 15% before therapy * serological alterations (liver, kidney) prohibiting application of simultaneous chemotherapy * respiratory motion of the tumour \> 10 mm (evaluated by 4D CT), also when methods for motion reduction (abdominal compression) are used
Where this trial is running
Dresden
- Department of Radiotherapy and Radiation Oncology — Dresden, Germany (Recruiting)
Study contacts
- Study coordinator: Esther Troost, Prof.
- Email: str.studien@uniklinikum-dresden.de
- Phone: +49 351 458 2238
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.