---
title: Preoperative Twice Daily Chemoradiation in Addition to Chemotherapy Prior to Surgery in Stage III Non-Small Cell Lung Cancer (NSCLC)
nct_id: NCT00176137
overall_status: COMPLETED
phase: PHASE3
sponsor: Heidelberg University
study_type: INTERVENTIONAL
primary_condition: Non-Small Cell Lung Cancer
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00176137.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00176137"
ct_last_update_post_date: 2008-04-22
last_seen_at: "2026-05-12T06:25:53.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Preoperative Twice Daily Chemoradiation in Addition to Chemotherapy Prior to Surgery in Stage III Non-Small Cell Lung Cancer (NSCLC)

**Official Title:** Cisplatin/Etoposide Followed by Twice-Daily Chemoradiation (hfRT/CT) Versus Cisplatin/Etoposide Alone Before Surgery in Stage III Non-Small Cell Lung Cancer. A Phase III Trial of the German Lung Cancer Cooperative Group (GLCCG)

**NCT ID:** [NCT00176137](https://clinicaltrials.gov/study/NCT00176137)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 500
- **Lead Sponsor:** Heidelberg University
- **Collaborators:** University Hospital Muenster, Lung Clinic Hemer, Kreiskrankenhaus Diekholzen, University Hospital, Saarland, FLT Berlin / Buch
- **Conditions:** Non-Small Cell Lung Cancer
- **Start Date:** 1995-10
- **Completion Date:** 2005-09
- **CT.gov Last Update:** 2008-04-22

## Brief Summary

Patients are randomized to (arm A) 3 cycles of cisplatin/etoposide, followed by hyperfractionated radiotherapy (hfRT)with concurrent carboplatin and vindesine then surgery and, if no or R1/2-resection, additional hfRT versus (arm B) 3 cycles of cisplatin/etoposide, followed by surgery and then RT.

The primary endpoint was progression free survival (PFS). With 500 patients evaluable an improvement of median PFS from 10 to 14 months could be detected.

## Detailed Description

Patients are randomized to (arm A) 3 cycles of cisplatin 55 mg/m2 (d 1 + 4)/etoposide 100 mg/m2 (d 1-4), followed by hyperfractionated radiotherapy (hfRT; 45 Gy, 2x1.5 Gy/d) with concurrent carboplatin (100 mg/m2) and vindesine (3 mg) (d 1, 8, 15), then surgery and, if no or R1/2-resection, additional hfRT (24 Gy; 2x1.5 Gy/d) versus (arm B) 3 cycles of cisplatin 55 mg/m2 (d 1 + 4)/etoposide 100 mg/m2 (d 1-4),followed by surgery and then RT (1.8 Gy/d) with 54 Gy or, if no or R1/2-resection, 68.4 Gy.

The primary endpoint was progression free survival (PFS). With 500 patients evaluable an improvement of median PFS from 10 to 14 months could be detected.

(University of Münster was the lead sponsor; as the trial was implemented in clinicaltrials.gov by the principal investigator after he had moved to University of Heidelberg this account is announced above)

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 69 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* non-small cell lung cancer proven by histology
* stage IIIA / stage IIIB
* mediastinoscopy
* performance score ECOG 0,1
* predicted postoperative FEV 1 \> 1.0 l

Exclusion Criteria:

* small cell lung cancer
* cardiac disability (NYHA III/IV)
* prior radio- or chemotherapy
* pregnancy
* other malignancy
```

## Interventions

- **preoperative radiochemotherapy** (PROCEDURE)

## Primary Outcomes

- **Progression free survival**

## Secondary Outcomes

- **Overall survival**

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00176137.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00176137*  
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