Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Carcinoma

Small Cell Lung Carcinoma

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Small Cell Lung Cancer

3D conformal thoracic radiotherapy at a total dose of 45 Gy in 30 fractions, 2 fractions per day, 5 days a week

3D conformal thoracic radiotherapy at a total dose of 60 Gy in 40 fractions, 2 fractions per day, 5 days a week

45 Gy in 30 fractions

3D conformal thoracic radiotherapy at a total dose of 60 Gy in 40 fractions, 2 fractions per day, 5 days a week. If doses to organs at risk exceed normal tissue tolerance, the dose may be lowered to a minimum of 54 Gy.

60 Gy in 40 fractions

Bjørn H Grønberg, md phd

The majority of patients with limited disease small cell lung cancer (SCLC) experience recurrent disease despite receiving concurrent chemoradiotherapy. New agents and dose-escalation of chemotherapy have not provided a survival benefit. Local failure accounts for high proportion of recurrences. Improved thoracic radiotherapy (TRT) might increase local control and thus reduce the recurrence rate and prolong survival. Positron emission tomography (PET CT) is better for staging of SCLC than computer tomography (CT) and bone scan. More precise localization of tumors leads to more accurate definition of target volumes for TRT and reduce the radiation dose to normal tissue. A large proportion of patients relapse and die within one and two year after therapy. Few patients survive longer than three years. Thus, two-year survival is considered a clinically highly relevant measure of efficacy.

The aim of this study is to compare two schedules of TRT with respect to local control, progression free survival, overall survival, toxicity and health-related quality of life. In addition patients who have the best outcomes and tolerate chemoradiotherapy will be characterized (e.g. clinical characteristics, blood biomarkers, body composition).

Two Schedules of Hyperfractionated Thoracic Radiotherapy in Limited Disease Small Cell Lung Cancer

A Randomized Phase II Study Comparing Two Schedules of Hyperfractionated Thoracic Radiotherapy in Limited Disease Small Cell Lung Cancer

All patients will be included in these analyses. Blood will be collected, the study group will define which markers to analyze when all patients have been enrolled.

measured for all patients from the date of the first day of the first course of chemotherapy until the date of death from any cause (or last contact/observation if lost to follow-up - or the follow-up is completed before all patients die).

measured for all patients from the date of the first day of the first course of PE to the first date of objective progression (according to RECIST 1.1) of disease or of death from any cause. For each patient who has not died or has non-progression at the cut-off date for the analysis, PFS will be censored at the date of the patient's last tumor assessment prior to the cut-off date. Statistical survival analyses will be done with Kaplan Meier. Log rank test will be used for comparing groups.

Proportion of all patients who experience disease recurrence within radiotherapy fields assessed by comparing dose plans and follow-up CT scans.

assessed for all patients receiving at least one course of chemotherapy from reported blood values and adverse event. Classified and graded according to CTCAE 4.0. Compared using Pearson's Chi-square and Fischer's exact tests.

assessed from completed questionnaires. Patients will report HRQoL on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 and the lung cancer specific module LC13. The QLQ-C30 measures fundamental aspects of HRQoL and symptoms commonly reported by cancer patients in general, the LC13 measures symptoms commonly associated with lung cancer and its treatment.

All HRQoL scores will be transformed to a scale from 0 to 100 according to the EORTC scoring manual. A difference in mean scores of \>10 is considered clinically relevant. For group comparisons of baseline scores during and after chemotherapy, and changes in scores from baseline, the Mann-Whitney test will be used. Primary HRQoL-endpoints are dysphagia and dyspnea.

St. Olavs Hospital

Oslo University Hospital

University Hospital of North Norway

Sorlandet Hospital HF

Norwegian University of Science and Technology

Carcinoma, Small Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

External beam radiotherapy

Peter Venner, MD

Patients who have limited stage small cell lung cancer are presently treated with chemotherapy and radiation therapy (RT). Despite this aggressive treatment the vast majority of patients will have their cancer recur after treatment. A recurrence is not curable at this time, therefore efforts to reduce recurrence rates are desirable. Due to the sensitivity of surrounding structures in the chest to radiation, it has not been possible to give doses that can cure most tumours. Three-dimensional conformal radiotherapy is a special form of radiation therapy that allows doctors to reduce the amount of radiation dose to normal tissues and therefore reduce toxicity and in turn, let them safely increase the dose to tumours. The purpose of this study is to determine whether the combination of three-dimensional conformal radiotherapy and chemotherapy will be a more effective treatment. If the treatment is found to be safe for the first group of patients, then the total radiation dose will be increased for the next group of patients who are treated on this study.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Two Schedules of Hyperfractionated Thoracic Radiotherapy in Limited Disease Small Cell Lung Cancer	NCT02041845	Small Cell Lung...	45 Gy in 30 fra... 60 Gy in 40 fra...	18 Years -	Norwegian University of Science and Technology
Study of Radiation Dose Intensity Concurrent With Chemotherapy For Limited Stage Small Cell Lung Cancer	NCT00126828	Carcinoma, Smal...	External beam r...	18 Years -	AHS Cancer Control Alberta

Spots Global Cancer Trial Database for radiotherapy dosage