RAJIV GANDHI UNIVERSITY OF
HEALTH SCIENCES, BENGALURU
ANNEXURE-II
Proforma for Registration of subjects for Dissertation
1. / Name AndAddress of the candidate (In Block Letters) / DR. SINDHU N
#1694/A, 6TH CROSS, 1ST STAGE, KUMARASWAMY LAYOUT, BANGALORE-560078.
2. / Name of the institution / BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE.
3. / Course of study and subject / M D (RADIOTHERAPY)
4. / Date of admission to course / 01-08-2013
5. / Title of the Topic:
“TO STUDY THE RELATIONSHIP BETWEEN CENTRAL LUNG DISTANCE (CLD) AND OCCURRENCE OF PULMONARY TOXICITY IN PATIENTS OF BREAST CANCER TREATED WITH COBALT 60 TELETHERAPY.”
6. / Brief resume of the intended work:
6.1 : Need for the study:
Breast cancer is the second most leading cause of cancer deaths in women all over the world, accounting for 26% of all malignancies in women which makes it essential to develop a holistic approach to the treatment plan in order to minimize the toxicities and maximize the disease free survival and overall survival1.
Radiotherapy plays a major role in the treatment, for the locoregional control of
the disease and survival either after mastectomy or after breast conservative surgery
especially when 4-7 lymph nodes are positive for tumour cells. It can be combined with
chemotherapy and/or hormonal therapy to optimize the benefits2.
Radiation pneumonitis is one of the important complications of radiotherapy to the breast which develops within 1 to 3 months of completion of treatment, it may completely resolve or evolve into fibrosis. Symptomatic pneumonitis is relatively rare but may require corticosteroids for its treatment. Severity of pulmonary toxicity is graded according to RTOG criteria1,2.
The occurrence and severity of radiation pneumonitis depends on the volume of the lung irradiated. Several studies have shown that the central lung distance (CLD) which is the perpendicular distance from the posterior tangential field edge to the posterior part of the anterior chest wall at the centre of the field, is the best predictor to estimate the percentage of irradiated lung volume (PIV). CLD is determined by CT scan taken in the treatment position3,4,5.
The purpose of the study is to prospectively estimate the CLD in all patients of breast cancer treated with radiotherapy using CT simulation and hence calculate the percentage of irradiated lung volume and correlate it with the incidence of lung toxicities in our institution.
6.2 Review of literature:
Carlos A. Parez et al in Principles and practice of Radiation Oncology states that Radiation therapy plays an essential and critical role in the management of breast cancer. In a general radiation oncology practice, breast cancer typically comprises approximately 25% of the total patient caseload. Symptomatic pneumonitis is infrequent. This clinical syndrome is noted one to several months after irradiation (393). Patients present with dry cough, shortness of breath, or fever. The risk for development of radiation pneumonitis may be related to the volume of lung irradiated1.
Gagliardi et al, retrospectively assessed on the basis of clinical symptoms and radiological findings to using a serial organ model and demonstrated that lung volume effect was relevant in the description of radiation pneumonitis3.
Bornstein et al, determined the lung irradiated in 40 patients with breast cancer using CT scan for treatment planning by measuring the CLD and maximum lung distance (MLD) and concluded that with a CLD of 1.5 cm, approximately 6% of the ipsilateral lung would be included which increases to 16% and 26% when CLD is increased to 2.5 cm and 3.5 cm respectively4.
Neal AJ, Yarnold JR in a study estimating the volume of lung irradiated during tangential breast irradiation using the central lung distance concluded that correlation between CLD and PLV for local and regional fields was significant on volumetric analysis. Although symptomatic RP requiring steroid medication was a rare complication, regional irradiation increased the incidence of RP, and such relationship can be expressed with a volumetric parameter of PLV5.
Lingos TI et al, estimated the overall incidence of symptomatic radiation pneumonitis to be 1.0% at a median follow-up of 77 months, it increased to 3.0% with the use of a supraclavicular radiation field and to 8.8% when concurrent chemotherapy was administered and was only 1.3% in patients who received sequential chemotherapy was given6.
The effect of tangential field technique on the pulmonary function was reported by Lund et al in 25 patients treated with radiotherapy. Dynamic and static lung volumes, distribution of ventilation and gas transfer were measured before irradiation and at various intervals up to 1 year following its completion. There was a small but statistically significant decrease in FEV1 and FVC at 3 months after irradiation which normalised within 1 year7.
6.3 Objectives of the study:
1) To study the actual occurrence of early radiation pneumonitis (RP) and role of volume of lung irradiated, radiation dose, fractionation and other influencing factors in the development of early RP.
2) To determine the best way to assess the percentage of lung volume irradiated.
7. / Materials and Methods:
7.1 Source of data:
The study will be conducted on patients attending the OPD in Radiotherapy Department, Victoria hospital, attached to Bangalore Medical College and Research Institute, Bangalore with histologically proven malignancy of breast during the study period from November 2013 to May 2015.
7.2 Study design: A prospective study.
7.3tudy period: November 2013 to May 2015.
7.4 Place of study: OPD in Radiotherapy Department, Victoria hospital, attached to Bangalore Medical College and Research Institute, Bangalore.
7.5 Sample size: 30 patients with histologically proven malignancy of breast, who fulfill the inclusion criteria will be enrolled in the study.
7.6 Inclusion criteria: Patients with
o Age between 18 and 70 years.
o Both sexes.
o KPS ≥ 70.
o Proven cases of carcinoma breast receiving radiotherapy.
7.7 Exclusion criteria: Patients with
o Age < 18 years and > 70 years.
o KPS < 70.
o Patients who had prior radiation therapy to thorax.
o Pre-existing lung pathology.
o Patients who have received pulmonary toxic drugs.
7.8 Methodology:
Informed consent will be taken from all patients. After detailed clinical examination and histopathological evaluation, proven cases of non-metastatic breast cancer, will be treated with external beam radiotherapy using Cobalt -60 gamma rays mostly by conventional fractionation (2 Gray per fraction, 5 fractions per week) to a total dose of 50 Gray in 25 fractions with tangential fields after undergoing CT simulation as a part of treatment planning. Supraclavicular fields, axillary fields and posterior axillary boost maybe included in the treatment plan depending on the nodal status.
Central lung distance (CLD) will be estimated in all patients using CT simulation and the volume of lung irradiated will be calculated based on the CLD.
Baseline spirometry and chest x ray PA view will be done in all the patients included in the study before the start of radiotherapy then it will be repeated at 1 month and 3 months after the start of treatment.
Once the treatment is completed patients will be examined for signs and symptoms of skin reaction as well as pulmonary reaction. Follow-up is done once in a month for a minimum period of 3 months.
The grading of pulmonary toxicity will be done according to radiotherapy oncology group (RTOG) criteria.
7.9 Statistical method: Appropriate statistical method will be used. It will be done as a descriptive study.
7.10 Does the study require any investigations or interventions to be conducted on patients or other humans or animals?
- Yes.
- Computerized tomography.
- Spirometry.
- Chest X Ray PA view.
No animal study is required.
7.11 Has ethical clearance been obtained from your institution in case of 7.11?
Yes.
8. / List of reference:
1) Edward C. Halperin, David E. Wazer, Carlos A. Parez, Luther W. Brady, Principles and practice of Radiation Oncology, Chapter 56, 57: Breast cancer- early stage, locally advanced and Recurrent disease, Postmastectomy radiation, systemic therapies. 6th ed. Lippincott Williams & Wilkins, 2013.
2) Vincent T Devita Jr, Theodore S. Lawrence, Steven A Rosenberg, Principles and practice of Oncology, Chapter 105, 106: Molecular Biology of Breast Cancer, Malignant Tumors of the Breast. 9th ed. Lippincott Williams & Wilkins, 2011.
3) Gagliardi G, Bjo _hle J, Lax I, Ottolenghi A, Eriksson F, Liedberg A, et al. Radiation pneumonitis after breast cancer irradiation: analysis of the complication probability using the relative seriality model. Int J Radiation Oncology Biol Phys 2000;46:373-81.
4) Bornstein BA, Cheng CW, Rhodes LM, Rashid H, Stomper PC, Siddon RL, et al. Can simulation measurements be used to predict the irradiated lung volume in the tangential fields in patients treated for breast cancer? Int J Radiation Oncology Biol Phys 1990;18:181-7.
5) Neal AJ, Yarnold JR. Estimating the volume of lung irradiated during tangential breast irradiation using the central lung distance. Br J Radiology 1995;68:1004-8.
6) Lingo TI, Recht A, Vicini F, et al: Radiation pneumonitis in breast cancer patients treated with concervative surgery and radiation therapy, Int J Radiat Oncol Biol Phps 21:355-366, 1991.
7) Lund MB, Myhre KI, Melsom H, et al: The effect on pulmonary function of tangential field radiotherapy for carcinoma of breast, Br J Radiol 64:520-523, 1991.
8) Lind PA, Rosfors S, Wennberg B, et al: Pulmonary function following adjuvant chemotherapy and radiotherapy for breast cancer and issue of three dimensional treatment planning, Radiotherapy Oncology 49:245-254, 1998.
9) Rancati T, Wennberg B, Lind P, et al: Early clinical and radiological pulmonary complications following breast cancer radiation therapy: NTCP fit with four different models, Radiotherapy Oncology 82:308-316, 2007.
10) Minor GI, Yashar CM, Spanos WJ Jr, Jose BO, Silverman CL, Carra- scosa LA, et al. The relationship of radiation pneumonitis to treated lung volume in breast conservation therapy. Breast J 2006;12:48-52.
11) Eui KC, Kyung HS, Dae YK et: Radiation Pneumonitis after Adjuvant Radiotherapy for Breast Cancer: A Volumetric Analysis Using CT Simulator, J Breast Cancer 2009 June; 12(2): 73-8.
9. / Signature of the candidate
10. / Remark of the guide / This study will help in the better management of adverse effects of radiotherapy in treatment of breast cancer.
11. / 11.1 Name and
designation of Guide
11.2 Signature / DR. IQBAL AHMED, MDRT,
PROFESSOR AND HOD,
DEPARTMENT OF RADIOTHERAPY,
BANGALORE MEDICAL COLLEGE & RESEARCH INSTITUTE,
BANGALORE.
11.3 Head of the
Department
11.4 Signature / DR. IQBAL AHMED, MDRT,
PROFESSOR AND HOD,
DEPARTMENT OF RADIOTHERAPY,
BANGALORE MEDICAL COLLEGE & RESEARCH INSTITUTE,
BANGALORE.
12 / 12.1 Remarks of the Principal
12.2 Signature
ANNEXURE
INFORMED CONSENT FORM
I ______(name of patient) and my relatives have been informed in my own language that I’m suffering from cancer of ______stage______
I have been explained regarding the need for radiotherapy and chemotherapy and the investigations required prior to, during and after the treatment.
I have been informed in detail regarding the possible side effects during and after chemo and radiotherapy. Doctors have informed that measures will be taken to keep these side effects as low as possible.
I give fully informed and valid consent in my conscious mind.
Signature of the patient ______
Signature of the relative ______
Name of the relative ______
Relationship ______