Clinical trial · Interventional
Proton Therapy to Reduce Acute Normal Tissue Toxicity in Locally Advanced Non-small-cell Lung Cancer
NCT02731001CI-TRIAL-00053403PRONTOXunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aims of the study are to reduce acute radiation induced side effects, i.e. pneumonitis and esophagitis grade II or higher by the use of proton therapy compared to photon radiotherapy of equal total dose. Secondary endpoints include evaluation of quality of life, loco-regional control, survival and late radiation induced side effects.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photon therapy | Radiation | — | UNRESOLVED |
| Proton therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Proton therapy
- description
- Patients within the proton arm will receive 66 Gy(RBE) delivered with 6 fractions per week.
- interventionNames
- Radiation: Proton therapy
- type
- ACTIVE_COMPARATOR
- label
- Photon therapy
- description
- Patients within the photon arm will be treated by intensity modulated radiotherapy with 6 fractions per week to a total dose of 66 Gy.
- interventionNames
- Radiation: Photon therapy
Primary outcomes (1)
- measure
- Occurrence of acute and intermediate radiation induced side effects
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDZschaeck S, Simon M, Lock S, Troost EG, Stutzer K, Wohlfahrt P, Appold S, Makocki S, Butof R, Richter C, Baumann M, Krause M. PRONTOX - proton therapy to reduce acute normal tissue toxicity in locally advanced non-small-cell lung carcinomas (NSCLC): study protocol for a randomised controlled trial. Trials. 2016 Nov 15;17(1):543. doi: 10.1186/s13063-016-1679-4. PMID 27846903