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A Phase I/II Trial of Isotoxic Accelerated Radiotherapy in the Treatment of Patients With Non-small Cell Lung Cancer


Phase 1/Phase 2
16 Years
N/A
Open (Enrolling)
Both
Locally Advanced Non-small Cell Lung Cancer

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Trial Information

A Phase I/II Trial of Isotoxic Accelerated Radiotherapy in the Treatment of Patients With Non-small Cell Lung Cancer


Main inclusion criteria:

1. Histologically or cytologically confirmed stage II - IIIb NSCLC (see appendix II)

2. Inoperable disease (as assessed by a lung cancer MDT with thoracic surgical input) or
operable but the patient refuses surgery

3. Disease which can be encompassed within a radical radiotherapy treatment plan in
keeping with standard practice at the participating centre

4. WHO Performance Status 0 or 1 (Appendix III)

5. Adequate respiratory function: FEV1 ≥ 1.0 litre, DLco (transfer factor) ≥ 40% of
predicted and Kco (DLco/VA) > 40% predicted on baseline lung function tests

6. Blood Haemoglobin ≥ 10g/dL

7. No prior thoracic radiotherapy

8. Age ≥ 16 years

9. Considered fit to receive trial treatment

10. Estimated life expectancy of more than 3 months

11. Written informed consent obtained

12. Patient consents for electronic CT scan and planning data to be used for future
research

Main exclusion criteria:

1. Medically unstable (e.g. unstable diabetes, uncontrolled hypertension, infection,
hypercalcaemia or very symptomatic ischaemic heart disease)

2. Previous or current malignant disease likely to interfere with protocol treatment

3. Pancoast tumours

4. Connective tissue disorders (e.g. Scleroderma, Systemic Lupus Erythematosus)

5. Interstitial lung disease

6. Women who are pregnant or lactating

7. Women of childbearing potential who are not using adequate contraceptive precautions

Primary outcome measure:

Phase I:

• Establish the maximum tolerated dose (MTD) to the oesophagus to use as the
recommended Phase II dose.

Phase II:

• Toxicity rate (grade 3 and 4) at three months.

Secondary outcome measures

Phase I:

• Chronic oesophagitis or stricture occurring/persisting two months or more after
completion of radiotherapy

Phase II:

- Local control at three months (to include complete response, partial response and
stable disease)

- Feasibility

- Time to Local Progression; measured in days from the day of trial entry to the
date of first clinical evidence of progressive disease at the primary site

- Time to distant metastases measured in days

- Overall Survival; measured in days, from the day of trial entry to the day of
death (from any cause)

- Toxicity; pulmonary, oesophageal, spinal cord and cardiac grade 3 or 4 toxicity
occurring up to three months after radiotherapy

- Radiotherapy Quality Assurance. A detailed QA program will be in place to ensure
adherence to the protocol. Major and minor deviations will be documented


Inclusion Criteria:



1. Histologically or cytologically confirmed stage II - IIIb NSCLC (see appendix II)

2. Inoperable disease (as assessed by a lung cancer MDT with thoracic surgical input) or
operable but the patient refuses surgery

3. Disease which can be encompassed within a radical radiotherapy treatment plan in
keeping with standard practice at the participating centre

4. WHO Performance Status 0 or 1 (Appendix III)

5. Adequate respiratory function: FEV1 ≥ 1.0 litre, DLco (transfer factor) ≥ 40% of
predicted and Kco (DLco/VA) > 40% predicted on baseline lung function tests

6. Blood Haemoglobin ≥ 10g/dL

7. No prior thoracic radiotherapy

8. Age ≥ 16 years

9. Considered fit to receive trial treatment

10. Estimated life expectancy of more than 3 months

11. Written informed consent obtained

12. Patient consents for electronic CT scan and planning data to be used for future
research

13. Patient is available for follow up

Exclusion Criteria:

1. Medically unstable (e.g. unstable diabetes, uncontrolled hypertension, infection,
hypercalcaemia or very symptomatic ischaemic heart disease)

2. Previous or current malignant disease likely to interfere with protocol treatment

3. Pancoast tumours

4. Connective tissue disorders (e.g. Scleroderma, Systemic Lupus Erythematosus)

5. Interstitial lung disease

6. Women who are pregnant or lactating

7. Women of childbearing potential who are not using adequate contraceptive precautions

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Phase I: Establish the maximum tolerated dose (MTD) to the oesophagus to use as the recommended Phase II dose.

Outcome Time Frame:

toxicity assessed up to 60 days after last Radiotherapy dose

Safety Issue:

No

Principal Investigator

Jason Lester, MBBS, MRCP, FRCR

Investigator Role:

Principal Investigator

Investigator Affiliation:

Velindre Cancer Centre

Authority:

United Kingdom: Research Ethics Committee

Study ID:

2009/VCC/0080

NCT ID:

NCT01537991

Start Date:

January 2012

Completion Date:

December 2013

Related Keywords:

  • Locally Advanced Non-Small Cell Lung Cancer
  • radiotherapy
  • non small cell lung cancer
  • isotoxic
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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