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A Phase I/II Study of Radiation Dose Intensity Concurrent With Chemotherapy For Limited Stage Small Cell Lung Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Carcinoma, Small Cell

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Trial Information

A Phase I/II Study of Radiation Dose Intensity Concurrent With Chemotherapy For Limited Stage Small Cell Lung Cancer

Radiotherapy represents one of the primary treatment modalities for patients with limited
stage small cell lung cancer (SCLC). With contemporary concurrent radiotherapy and
chemotherapy, approximately 20% of patients survive 5 years. While distant metastases are
common, local (intrathoracic) failures are common as well, occurring in 40% of treated
patients. Reducing local failure rates may lead to improved survival for these patients.
There appears a growing body of data, which suggests a radiation dose response relationship
for SCLC. However, the close proximity of critical normal structures, such as the spinal
cord and esophagus, to the primary tumour limits the prescription dose in conventional
radiotherapy. Three Dimensional Conformal Radiotherapy (3DCRT) offers the possibility of
reducing normal tissue irradiation and hence reducing the treatment toxicity while
maintaining the dose of radiation to the tumour. Another strategy is accelerated
fractionation, which shortens the treatment time by allowing less opportunity for tumour
cell repopulation. The use of 3DCRT with larger radiation fraction size should maintain
satisfactory treatment related toxicity while permitting the potential gains of accelerated
fractionation and dose escalation. In this study, patients with limited stage SCLC who are
eligible will be treated with a large field (low dose) radiotherapy followed by accelerated
3DCRT given concurrently with standard Cisplatin Etoposide chemotherapy.

Primary Objective: To determine the maximum tolerable dose of radiotherapy for SCLC

Secondary Objectives:

1. To assess treatment toxicity

2. To assess quality of life and retention of pulmonary function

3. To assess progression-free survival on this regimen

Schema: Eligible patients will receive 4 cycles of Cisplatin Etoposide chemotherapy.
Thoracic radiotherapy will be given concurrently starting with cycle #2 of chemotherapy.
Only one dose level will be open at a time. Four dose levels are planned all delivered in 25
fractions once daily over 5 weeks:

1. 50 Gy (2 Gy per fraction),

2. 58 Gy,

3. 62 Gy,

4. 65 Gy. Patients, who achieve a complete response at the end of chemotherapy and
thoracic radiotherapy, will receive prophylactic cranial irradiation.

Evaluation and Follow-up: Patients will be assessed and evaluated at least weekly during
radiation therapy. Following treatment, patients will be seen 1 month after the completion
of treatment, then every 3 months until 2 years, then every 6 months. Chest x-rays will be
performed at each follow-up. CT scan of chest and pulmonary function tests will be performed
every 6 months for the first 2 years, then yearly.

Inclusion Criteria:

- Histologically proven small cell lung cancer

- Age equal to or greater than 18 years

- Good performance status

- Signed study consent form

Exclusion Criteria:

- Patients who have undergone resection

- Wrong histology

- Previous thoracic/neck radiotherapy

- Prior chemotherapy

- Previous ME within 6 months

- Pregnant

- Tumour too large to irradiate safely

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

grade 3 RT toxicity rate

Principal Investigator

Peter Venner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Alberta Health Services


Canada: Health Canada

Study ID:

LU-11-0031 / 17141



Start Date:

January 2003

Completion Date:

October 2007

Related Keywords:

  • Carcinoma, Small Cell
  • radiotherapy, conformal
  • lung neoplasm
  • radiotherapy dosage
  • Carcinoma
  • Lung Neoplasms
  • Small Cell Lung Carcinoma
  • Carcinoma, Small Cell