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Neo-adjuvant Treatment in Non-Small Cell Lung Cancer (NSCLC)

NCT01059188 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2022-03-11

No results posted yet for this study

Summary

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized 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. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying the side effects of giving cetuximab together with cisplatin and docetaxel before radiation therapy and cetuximab followed by surgery and to see how well it works in treating patients with stage IIIB non-small cell lung cancer that can be removed by surgery.

Conditions

Interventions

DRUG

cetuximab

400 mg/m2 initial dose on day 1 250 mg/m2 weekly starting on day 8 and for 12 weeks

DRUG

cisplatin

50 mg/m2 on day 1 and 2 of 21 day cycles, for 3 cycles

DRUG

docetaxel

85 mg/m2 day 1 of 21 day cycles, for 3 cycles

RADIATION

Radiotherapy

44 Gy (PTV1=30 Gy, PTV2=14 Gy), for 3 weeks, after the 3 cycles of Cisplatin / Docetaxel treatment

PROCEDURE

Surgery

Ipsilateral formal mediastinal lymphadenectomy. In case of involved N3 lymph nodes, resection of the precarinal and contralateral nodes.

Sponsors & Collaborators

  • Swiss Cancer Institute

    lead OTHER

Principal Investigators

  • Solange Peters, MD · Centre Hospitalier Universitaire Vaudois

  • Daniel C. Betticher, MD · Kantonsspital Freiburg

  • Miklos Pless, Prof · Kantonsspital Winterthur KSW

  • Roger Stupp, MD · Centre Hospitalier Universitaire Vaudois

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-03
Primary Completion
2016-12-09
Completion
2022-03-08

Countries

  • Switzerland

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01059188 on ClinicalTrials.gov