Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)
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| ClinicalTrials.gov Identifier: NCT01102231 |
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Recruitment Status :
Completed
First Posted : April 13, 2010
Results First Posted : February 16, 2021
Last Update Posted : February 16, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stage III Non-small Cell Lung Cancer | Drug: Chemotherapy Drug: ERBITUX Radiation: Radiotherapy | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 106 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Study of Pemetrexed + Cetuximab + Cisplatin With Concurrent Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC) |
| Actual Study Start Date : | March 2010 |
| Actual Primary Completion Date : | January 2014 |
| Actual Study Completion Date : | December 2015 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: A
Chemoradiotherapy
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Drug: Chemotherapy
Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles) Drug: ERBITUX The initial dose of cetuximab (ERBITUX) is 400 mg/m² intravenously administered over 120 minutes, followed by 11 weekly infusions at 250 mg/m² IV over 60 minutes Radiation: Radiotherapy 66 Gy (2 Gy by fraction, 5 fractions by week) |
- Disease-Control Rate [ Time Frame: 16 weeks after inclusion ]
percentage of patients with disease control (complete response + partial response + stable disease) according to RECIST 1.1 criteria Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.
Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for Progressive Disease (at least a 20% increase in the sum of diameters of target lesions).
- 18-month Overall Survival Rate [ Time Frame: 18 months ]Percentage of patient alive 18 months after registration
- Progression Free Survival [ Time Frame: 52.3 months (median duration of follow-up) ]
Progression-free survival is defined as time between date of inclusion and progression or all-cause death.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- non-squamous stage III non-small cell lung cancer
- measurable disease (RECIST 1.1)
- ECOG performance status 0-1
- normal organ and marrow function
Exclusion Criteria:
- prior chest radiation therapy
- history of any cancer other than NSCLC (except non-melanoma skin cancer or carcinoma in situ of the cervix) within the last five years.
- Prior therapy with known specific inhibitors of the EGFR.
- history of severe allergic reaction to prior therapy with monoclonal antibodies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01102231
Show 38 study locations
| Principal Investigator: | Jean Trédaniel, MD, PhD | IFCT, GH Paris Saint-Joseph | |
| Principal Investigator: | Françoise Mornex, MD, PhD | IFCT, HCL Lyon-Sud |
Publications:
| Responsible Party: | Intergroupe Francophone de Cancerologie Thoracique |
| ClinicalTrials.gov Identifier: | NCT01102231 |
| Other Study ID Numbers: |
IFCT-0803 |
| First Posted: | April 13, 2010 Key Record Dates |
| Results First Posted: | February 16, 2021 |
| Last Update Posted: | February 16, 2021 |
| Last Verified: | January 2021 |
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases |
Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Cetuximab Antineoplastic Agents, Immunological Antineoplastic Agents |