Clinical trial · Interventional
INTENSE: A Phase I/II Study of INhomogeneous Targeted Dose Escalation in Non-Small CEll Lung Cancer
NCT02764086CI-TRIAL-00107823terminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Accrual lower than anticipated and not expected to improve
Summary
Brief summary (as posted)
This is a prospective non-randomised Phase I/II study with patients recruited to escalated dose cohorts. Escalated dose to the iGTV (internal gross tumour volume), with 60 Gy to the conventional PTV (planning target volume), will be delivered to successive cohorts of participants (6-12 participants/cohort) until the maximum tolerated oesophageal dose is determined. The minimum dose will be 60 Gy delivered via intensity modulated radiation therapy (IMRT) or volume modulated arc therapy (VMAT), planned on an Average Intensity Projection (AVIP) dataset. Standard of care chemotherapy. There will be two treatment arms; one with patients who are planned to receive neo-adjuvant or no chemotherapy, and the other with patients who are planned to receive concurrent chemotherapy.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Trial Cohort Description
- description
- Escalated dose of min 65Gy to the iGTV, with 60Gy to PTV delivered to successive cohorts of patients(pts) until the MTD oesophageal dose is determined. Toxicity will be analysed 2 months post 6pts treated in a cohort. If: ≤2pts have ≥G3 toxicity, next cohort will be enrolled \& receive escalated dose (an additional +5Gy at each escalation upto max 75Gy)/3 of 6pts have ≥G3 toxicity, a further 6pts will be recruited into that dose level/≥4pts have ≥G3 toxicity, the MTD is fixed at dose level of previous cohort Cohort is extended to 12pts: If: ≤4pts have ≥G3 toxicity, next cohort will be enrolled \& receive escalated dose/5 of 12pts have ≥G3 toxicity, the MTD is fixed at that dose level \& recruitment continues up to 24pts/≥6pts have ≥G3 toxicity, the MTD is fixed at the dose level of previous cohort. Once the max dose cohort is established, recruiting will continue at that dose until 24pts. Concurrent \& neo-adjuvant/no chemotherapy arms will be escalated independently of each other
- interventionNames
- Radiation: Radiation
Primary outcomes (1)
- measure
- To assess the safe delivery of an achievable level of dose escalation in a dose escalated and intensified RT regime delivered via VMAT/IMRT and focused on the GTV by the proportion of grade ≥3 toxicities determined to be related to RT
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18 years of age 2. ECOG (European Cooperative Oncology Group) performance status 0-2 (0-1 for concurrent chemotherapy) 3. Weight loss \<10% within 3 months of diagnosis 4. Histological diagnosis (biopsy or cytology) of NSCLC (Squamous Cell Carcinoma (SCC), Adenocarcinoma, Large Cell). Eligible NSCLC stages: IIA (provided N1); IIB (including T3N0 if unresectable or unsuitable for stereotactic ablative body radiation therapy (SABR)); IIIA and IIIB 5. Inoperable (as per Multi-Disciplinary Team (MDT)) or patient refuses surgery 6. Respiratory function: Forced Expiratory Volume (FEV1) ≥ 1L or ≥ 40% of predicted Diffusing Capacity of Lung for Carbon Monoxide (DLCO) ≥ 40% 7. Radiological confirmation of disease via a Positron Emission Tomography (PET) scan prior to registration. 8. Life expectancy, from causes other than lung cancer, of greater than 12 months (as per physician's opinion) 9. Females of child bearing potential (see Appendix H) must not be pregnant and must be prepared to use adequate contraception methods during treatment. Males whose female partners are of child-bearing potential must be prepared to use adequate contraception methods during treatment. Examples of effective contraception methods are a condom or a diaphragm with spermicidal jelly, or oral, injectable or implanted birth control. 10. Provision of written consent in line with ICH-GCP guidelines Exclusion Criteria: 1. Previous thoracic radiation therapy 2. Known co-existing or prior malignancy which is likely to interfere with treatment or assessment of outcomes 3. Known distant metastases or metastatic pleural effusion 4. Pancoast tumours (tumour of the pulmonary apex) 5. Supraclavicular nodal involvement 6. Spinal cord involvement 7. Patients with syndromes or conditions associated with increased radiosensitivity or development of lung fibrosis 8. Suitable for SABR 9. Idiopathic pulmonary fibrosis/usual interstitial pneumonia 10. Uncontrolled intercurrent illness that is likely to interfere with treatment or assessment of outcomes 11. Psychiatric illness/social situations that would limit compliance with study requirements 12. Pregnant or lactating at the time of proposed randomisation 13. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study, or if it is felt by the research / medical team that the patient may not be able to comply with the protocol
References
Publications (0)
Data not yet available
No reference posted for this study.