Clinical trial · Interventional
Proton Beam Radiation Therapy and Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Can Be Removed By Surgery
Feasibility and PhaseI/II Trial of Preoperative Proton Beam Radiotherapy With Concurrent Chemotherapy for Resectable Stage IIIA or Superior Sulcus NSCLC
- 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)
RATIONALE: Specialized radiation therapy, such as proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue in patients with non-small cell lung cancer. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving proton beam radiation therapy together with combination chemotherapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of proton beam radiation therapy when given together with cisplatin and etoposide and to see how well it works in treating patients with stage III non-small cell lung cancer that can be removed by surgery.
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 |
|---|---|---|---|
| Stage IIIA Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients undergo proton beam radiotherapy over 5.5-7.5 weeks. Patients receive concurrent chemotherapy comprising cisplatin IV on days 1, 8, 29, and 36 and etoposide IV on days 1-5 and days 29-33.Treatment continues in the absence of disease progression or unacceptable toxicity. Beginning 4-6 weeks after completion of chemoradiotherapy, patients may undergo surgical resection or additional chemoradiotherapy.
- interventionNames
- Radiation: proton beam radiation therapy
- Drug: cisplatin
- Drug: etoposide
- Procedure: therapeutic conventional surgery
Primary outcomes (3)
- measure
- Number of Participants Deemed Feasible to Receive Intervention
- timeFrame
- 90 Days
- description
- Feasibility will be based on multiple radiation planning and treatment parameters. Study will be deemed feasible if all patients are deemed feasible.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion * Histologically confirmed diagnosis of NSCLC * Stage IIIA or Potentially resectable superior sulcus tumors * No evidence of distant metastatic disease as documented by MRI of the brain and PET/CT * Patients must have a Karnofsky Performance Status of \>= 60 * Patients must be able to provide informed consent * WBC \>= 4000/mm\^3 * Platelets \>= 100,000 mm\^3 * Creatinine =\< 1.2 mg/dl (urinary diversion is permitted to improve renal function) * Patients must have bilirubin =\< 1.5 mg/dl * Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.); hysterectomy or menopause must be clinically documented * Negative pregnancy test for women of child-bearing age Exclusion * Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma) \[For pts that will be on definitive treatment study, otherwise delete for umbrella recurrent protocol\] * Pregnant women, women planning to become pregnant and women that are nursing * Actively being treated on any other research study
References
Publications (1)
- DERIVEDSimone CB 2nd, Yegya-Raman N, Manjunath S, Verma V, Shabason JE, Xu L, Cengel KA, Levin WP, Berman AT, Christodouleas JP, Aggarwal C, Cohen RB, Langer CJ, Pechet TT, Singhal S, Kucharczuk JC, Rengan R, Feigenberg SJ. Prospective Feasibility and Phase 1/2 Trial of Preoperative Proton Beam Therapy With Concurrent Chemotherapy for Resectable Stage IIIA or Superior Sulcus Non-Small Cell Lung Cancer. Int J Radiat Oncol Biol Phys. 2023 Nov 1;117(3):683-689. doi: 10.1016/j.ijrobp.2023.05.016. Epub 2023 May 17. No abstract available. PMID 37201756