A 2-step phase I study evaluating the safety of (neo-)adjuvant cisplatin-pemetrexed and stereotactic radiotherapy for patients with stage IB non-small-cell lung cancer

Standard treatment for stage IB (T2N0M0) non-small-cell lung cancer is surgery.
When surgical treatment is not possible because of poor physical condition (for
example lung emfysema) or patient's refusal, there's a possibility for
stereotactic radiotherapy treatment. At the VU University Medical Center,
there's already a large experience with this treatment, and results seem te be
comparable with surgery, but involves less risks and complications. Despite the
curative intent of these treatments, there's a relative large chance that the
lung cancer relapses in the lung, lymph nodes or as metastasis. That's why it
is logical to add chemotherapy to the treatment, because chemotherapy spreads
and works through the whole body, and in theory destroys all (remaining) cancer
cells. The chemotherapy in this study (cisplatin and pemetrexed) is now already
being used for locally advanced or metastasized non-small-cell lung cancer.
However, it is not known whether the chemotherapy should be administered
afterwards or before stereotactic radiotherapy in stage IB, without causing too
much toxicity. Therefore, a phase I study is developed to observe and record
toxicity of this treatment, and to study the feasibility, before proceeding to
phase II or even phase III studies.

Primary goal is studying the safety and feasibility of administering
chemotherapy (cisplatin and pemetrexed) after of before treatment with
stereotactic radiotherapy by observing and recording toxicity during and after
the study.

In this study, the chemotherapy is administered in one dosage before or after
stereotactic radiotherapy, and toxicity can be observed. The two groups (before
or after) can be compared with each other. Choice of group is determined by the
phase of the study (first after, then before).

Standard treatment for these patients is stereotactic radiotherapy. Three
courses of cisplatin-pemetrexed will be administered before or after
radiotherapy.

Patients participating in the study will be administered intravenously 3
courses of cisplatin-pemetrexed, before or after stereotactic radiotherapy.
Hospitalisation length is 3 days for 1 course. Chemotherapy and radiotherapy
often cause fatique. Observation of patients takes place by interviewing them
about side-effects, but it is also important to take blood samples. There is a
lot of experience with chemotherapy and the agents used in this study, but
chemotherapy can potentially be harmful for healthy body cells, especially for
the bone marrow and the kidneys. With good check-ups and additional measures
(vitamin B12 injections, dexamethasone tablets, saline infusion together with
the chemotherapy), efforts are made to prevent the more serious side-effects.