Clinical trial · Interventional
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer
Phase I/II Study Of Concurrent Chemotherapy And Escalating Doses Of Radiotherapy (RT) For Unresectable Non-Small Cell Lung Cancer (NSCLC) Using A New RT Paradigm
NCT00032032CI-TRIAL-00024971completedPhase 1ClinicalTrials.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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of radiation therapy when given with combination chemotherapy and to see how well they work in treating patients with non-small cell lung cancer that cannot be surgically removed.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- radiotherapy + paclitaxel + carboplatin
- description
- Patients undergo radiotherapy once daily 5 days a week for 7 weeks and 2 days (a total of 37 fractions). Patients concurrently receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes once weekly for 7 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Beginning 3 weeks after completion of radiotherapy, patients receive paclitaxel and carboplatin as above. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, once during the last week of radiotherapy, and then every 3 months for 2 years. Patients are followed at 3 weeks, every 3 months for 21 months, and then every 6 months for 3 years.
- interventionNames
- Drug: carboplatin
- Drug: paclitaxel
- Radiation: radiation therapy
Primary outcomes (2)
- measure
- Maximum tolerated dose (MTD) as assessed by dose-limiting toxicity within 1 month after completion of study treatment (phase I)
- timeFrame
- Up to 1 month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) * Stage I, II, or III NSCLC that is unresectable due to tumor extent or other medical reasons * Measurable disease * Tumor must not exceed volume that would require radiation volumes greater than those allowed on this study * No more than blunting of the costophrenic angle on chest x-ray due to pleural effusions * No more than small effusions seen on chest CT scan only * No supraclavicular adenopathy PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR * Direct bilirubin no greater than 1.5 times ULN * AST no greater than 3 times ULN Renal: * Creatinine clearance at least 40 mL/min Cardiovascular: * No New York Heart Association class III or IV heart disease Pulmonary: * FEV\_1 at least 1 L or 35% of predicted Other: * No grade 2 or greater peripheral neuropathy * No weight loss of 10% or more within the past 3 months * No uncontrolled infection * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinoma (carcinoma in situ), or localized prostate cancer * No other severe underlying disease that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic: * No prior biologic therapy for NSCLC * No concurrent biologic therapy * No concurrent prophylactic filgrastim (G-CSF) Chemotherapy: * No prior chemotherapy for NSCLC * No other concurrent chemotherapy Endocrine therapy: * No prior endocrine therapy for NSCLC Radiotherapy: * No prior radiotherapy for NSCLC Surgery: * No prior surgery for NSCLC
References
Publications (3)
- RESULTSchild S, Graham D, Hillman S, et al.: Survival of patients (pts) treated with high-dose radiotherapy (RT) and concurrent chemotherapy for unresectable non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 27 (Suppl 15): A-7544, 2009.
- RESULTSchild SE, McGinnis WL, Graham D, Hillman S, Fitch TR, Northfelt D, Garces YI, Shahidi H, Tschetter LK, Schaefer PL, Adjei A, Jett J. Results of a Phase I trial of concurrent chemotherapy and escalating doses of radiation for unresectable non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2006 Jul 15;65(4):1106-11. doi: 10.1016/j.ijrobp.2006.02.046. Epub 2006 May 26. PMID 16730134
- DERIVEDSchild SE, Hillman SL, Tan AD, Ross HJ, McGinnis WL, Garces YA, Graham DL, Adjei AA, Jett JR; Mayo Clinic, North Central Cancer Treatment Group. Long-Term Results of a Trial of Concurrent Chemotherapy and Escalating Doses of Radiation for Unresectable Non-Small Cell Lung Cancer: NCCTG N0028 (Alliance). J Thorac Oncol. 2017 Apr;12(4):697-703. doi: 10.1016/j.jtho.2016.12.021. Epub 2017 Jan 12. PMID 28089762