Clinical trial · Interventional
Combination Chemotherapy and Computer-Planned Radiation Therapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
Induction/Concurrent Chemotherapy and Dose-Escalated Three Dimensional Thoracic Radiation for Patients With Stage III Non Small Cell Lung Cancer: A Randomized Phase II Study
- 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. Computer systems that allow doctors to create a 3-dimensional picture of the tumor to plan treatment may result in more effective radiation therapy. It is not yet known which chemotherapy and/or radiation therapy regimen is more effective in treating non-small cell lung cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of different combination chemotherapy regimens and 3-dimensional radiation therapy in treating patients who have unresectable stage III non-small cell lung cancer.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| gemcitabine hydrochloride | Drug | Gemcitabine | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Paclitaxel + Carboplatin
- description
- Paclitaxel and carboplatin induction (2 cycles)followed by chemotherapy with the addition of radiotherapy for 7 cycles
- interventionNames
- Drug: carboplatin
- Drug: paclitaxel
- Radiation: radiation therapy
- type
- EXPERIMENTAL
- label
- Gemcitabine + Carboplatin
- description
- Gemcitabine and carboplatin induction (2cycles) followed by chemotherapy with the addition of radiotherapy for 7 cycles
- interventionNames
- Drug: carboplatin
- Drug: gemcitabine hydrochloride
- Radiation: radiation therapy
Primary outcomes (1)
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)
* Squamous cell carcinoma
* Adenocarcinoma, including bronchoalveolar cell carcinoma
* Large cell anaplastic carcinoma, including giant and clear cell carcinoma
* Inoperable stage IIIA or IIIB disease
* No direct invasion of vertebral body
* Tumors adjacent to a vertebral body without bone invasion allowed if all gross disease can be encompassed in radiotherapy boost field
* Contralateral mediastinal disease (N3) allowed if all gross disease can be encompassed in radiotherapy boost field
* No scalene, supraclavicular, or contralateral hilar node involvement
* Transudate, cytologically negative, non-bloody pleural effusion allowed if it can be encompassed in radiotherapy field
* No exudative, bloody, or cytologically malignant pleural effusion
* Evidence of pleural effusion by chest CT scan but not chest x-ray that is too small to tap allowed
* At least 1 unidimensionally measurable lesion
* At least 20 mm by conventional techniques OR
* At least 10 mm by spiral CT scan
* The following are not considered measurable disease:
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Abdominal masses that are not confirmed and followed by imaging techniques
* Cystic lesions
* Tumor lesions in a previously irradiated field
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Granulocyte count at least 1,500/mm3
* Platelet count at least 100,000/mm3
Hepatic:
* Bilirubin less than 1.5 mg/dL
* AST less than 2 times upper limit of normal
Renal:
* Creatinine clearance 20-130 mL/min for females
* Creatinine clearance 20-150 mL/min for males
Pulmonary:
* FEV1 at least 1.2 L
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other currently active malignancy (defined as completed prior therapy and considered to be at less than 30% risk of relapse) except non-melanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy for NSCLC
* No other concurrent chemotherapy
Endocrine therapy:
* No concurrent hormonal therapy except steroids for adrenal failure or septic shock, hormones for non-disease-related conditions (e.g., insulin for diabetes), or glucocorticosteroids as antiemetics
Radiotherapy:
* See Disease Characteristics
* No prior radiotherapy for NSCLC
Surgery:
* At least 2 weeks since prior exploratory thoracotomyReferences
Publications (3)
- RESULTSocinski MA, Blackstock AW, Bogart JA, Wang X, Munley M, Rosenman J, Gu L, Masters GA, Ungaro P, Sleeper A, Green M, Miller AA, Vokes EE. Randomized phase II trial of induction chemotherapy followed by concurrent chemotherapy and dose-escalated thoracic conformal radiotherapy (74 Gy) in stage III non-small-cell lung cancer: CALGB 30105. J Clin Oncol. 2008 May 20;26(15):2457-63. doi: 10.1200/JCO.2007.14.7371. PMID 18487565
- RESULTBlackstock AW, Socinski MA, Bogart J, et al.: Induction (Ind) plus concurrent (Con) chemotherapy with high-dose (74 Gy) 3-dimensional (3-D) thoracic radiotherapy (TRT) in stage III non-small cell lung cancer (NSCLC): preliminary report of Cancer and Leukemia Group B (CALGB) 30105. [Abstract] J Clin Oncol 24 (Suppl 18): A-7042, 374s, 2006.
- RESULTBlackstock AW, Socinski MA, Gu L, et al.: Initial pulmonary toxicity evaluation of chemoradiotherapy (CRT) utilizing 74 Gy 3-dimensional (3-D) thoracic radiation in stage III non-small cell lung cancer (NSCLC): a Cancer and Leukemia Group B (CALGB) randomized phase II trial. [Abstract] J Clin Oncol 23 (Suppl 16): A-7060, 635s, 2005.