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A randomized phase III study comparing induction chemotherapy to daily low dose Cisplatin both combined with high dose radiotherapy in patients with inoperable non-small cell lung cancer stage I, II and III.

A randomized phase III study comparing induction chemotherapy to daily low dose Cisplatin both combined with high dose radiotherapy in patients with inoperable non-small cell lung cancer stage I, II and III.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22854
Enrollment
100
Registered
2005-11-01
Start date
2003-05-30
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Randomisation of sequential versus concurrent chemoradiotherapy.

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pathologically confirmed Non-small cell lung cancer; 2. Medically inoperable or irresectable NSCLC T 1-4, N0-3, M0; 3. Age >18 yr; 4. Weight loss 0.99l, TLCO> 59%.

Exclusion criteria

Exclusion criteria: 1. Previous chemotherapy and/or radiotherapy of the chest; 2. Superior Vena cava syndrome; 3. Hemoptysis causing a decrease of the blood haemoglobin of > 1 mmol/L within 24 hours; 4. Pleural or pericardial effusion (except if negative cytology); 5. Uncontrolled infection; 6. Maximal length of the esophagus receiving 40 Gy of more than 18 cm, or maximal length of the esophagus receiving 66 Gy of more than 12 cm; 7. Serious medical risk factors involving any of the major organ systems which may prevent adherence to the treatment schedule; 8. Patients with pre-existant fibrotic lung disease; 9. Creatinin clearance 1.25 x normal value; 10. Bone marrow hypoplasia(Hb,6.8mmol/l, WBC,4x10 9 /l, platelets,100x10 9/l; 11. Recent myocardial infarction(<6 months) or evidence of heart failure; 12. Impossibility to limit the spinal cord dose to a maximum of 50Gy; 13. Impossibility to exclude 2/3 of the heart from the boost volume.

Design outcomes

Primary

MeasureTime frame
Disease-free survival, local control, pattern of recurrence.

Secondary

MeasureTime frame
Acute and late toxicity, Quality of Life.

Contacts

Public ContactA.L.J. Uitterhoeve

Academic Medical Center (AMC), Department of Radiotherapy, P.O. Box 22660

a.l.uitterhoeve@amc.uva.nl+31 (0)20 5664231

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)