Clinical trial · Interventional
Chemoradiotherapy in Patients With Localised Lung Cancer
A Randomised Phase II Study of Two Regimens of Palliative Chemoradiation Therapy in the Management of Locally Advanced Non Small Cell Lung Cancer
- 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 study compares 2 different methods of combined chemotherapy and radiotherapy for the treatment of localised lung cancer in patients not suitable for surgery. Hypothesis(es) to be tested: 1. Vinorelbine + cisplatin + high-dose palliative radiotherapy is superior to gemcitabine + high dose palliative radiotherapy in terms of efficacy in a multi-institutional setting 2. Vinorelbine + cisplatin + high-dose palliative radiotherapy is superior to gemcitabine + high dose palliative radiotherapy in terms of feasibility in a multi-institutional setting 3. Vinorelbine + cisplatin + high-dose palliative radiotherapy has a favourable toxicity profile relative to gemcitabine + high-dose palliative radiotherapy
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 Carcinoma | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| High dose Radiotherapy | Radiation | — | UNRESOLVED |
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Vinorelbine + cisplatin + high-dose palliative radiotherapy
- interventionNames
- Drug: Vinorelbine
- Radiation: High dose Radiotherapy
- Drug: Cisplatin
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- Gemcitabine + high-dose palliative radiotherapy
- interventionNames
- Drug: Gemcitabine
- Radiation: High Dose Radiotherapy
Primary outcomes (4)
- measure
- Objective response rate (RECIST criteria)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Histologically or cytologically proven non-small cell lung cancer.
* Planned high dose palliative radiation therapy for locoregional control. Examples include patients with:
1. Stage I - IIIB disease with
* disease technically unsuitable for radical therapy, or · weight loss in excess of 10%, or
* concurrent medical illness
2. Patients found to have a locally advanced thoracic disease suitable for radical therapy but on work up are found to have a FDG-PET only solitary metastasis.
* All potential patients, prior to registration, must be reviewed at a multidisciplinary lung oncology meeting attended by medical oncologists, radiation oncologists and radiologists.
* No prior radiotherapy or chemotherapy for non-small cell lung cancer.
* ECOG performance status 0, 1.
* Adequate hepatic, bone marrow and renal function.
* If patient is female of child bearing potential, she must not be pregnant or lactating. Males and females of reproductive potential must practise adequate contraception.
* Written informed consent.
Exclusion Criteria:
* Patient unable to receive all therapy as an outpatient.
* Significant medical conditions which in the opinion of the investigator would compromise the planned delivery of the chemotherapy and radiotherapy or which may be potentially exacerbated by these modalities.
* History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission and off all therapy for that cancer for at least 5 years.
* Receiving treatment with another investigational agent.References
Publications (0)
Data not yet available