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CTRI Number  CTRI/2018/03/012370 [Registered on: 06/03/2018] Trial Registered Retrospectively
Last Modified On: 26/02/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Study of quality of life after completion of Re-Radiation treatment in Head and Neck Cancer patients 
Scientific Title of Study   Quality of life and swallowing outcomes after re-irradiation for recurrent and second primary head and neck cancers. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
1833  Protocol Number 
Version No 1 Dated Oct 2016  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sarbani Ghosh Lasker 
Designation  Professor and Radiation Oncologist 
Affiliation  Tata Memorial Hospital 
Address  Room No 1226,HBB 11th Floor Tata Memorial Hospital Dr E Borges Road Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  9820834386  
Fax  02224146392  
Email  sarbanilaskar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sarbani Ghosh Lasker 
Designation  Professor and Radiation Oncologist 
Affiliation  Tata Memorial Hospital 
Address  Room No 1226,HBB 11th Floor Tata Memorial Hospital Dr E Borges Road Parel


MAHARASHTRA
400012
India 
Phone  9820834386  
Fax  02224146392  
Email  sarbanilaskar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Carlton Johnny 
Designation  Junior Resident 
Affiliation  Tata Memorial Hospital 
Address  Room No 206,HBB 2nd Floor Tata Memorial Hospital Dr E Borges Road Parel

Mumbai
MAHARASHTRA
400012
India 
Phone  9940434908  
Fax    
Email  carltonjohnny007@gmail.com  
 
Source of Monetary or Material Support  
Tata Memoral Hospital, Dr E Borges Road Parel Mumbai 400012 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [NIl] 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sarbani Ghosh Laskar  Tata Memorial Hospital  Room No 206,Department of Radiation Oncology Homi Bhabha Block Tata Memorial Hospital Dr E Borges Road Parel
Mumbai
MAHARASHTRA 
9820834386

sarbanilaskar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee II  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients receiving re-Irradiation (reRT).,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  NA 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Patients must have recurrence/ second primary (SPN) at least 6 months after prior radiotherapy.
2. Patients should have histopathological proof for both the primary tumor and at recurrence / second cancer in the head and neck region.
3. Patients should have been treated with radical intent for primary tumor with appropriate radical doses of radiation.
4. Patients who are diagnosed with recurrent or second cancer for which the radiation portals will overlap the fields of previously irradiated region.
5. In the recurrent setting the intention of treatment is radical.
 
 
ExclusionCriteria 
Details  1.Patients having recurrence/ second primary (SPN) before completion of 6 months of prior radiotherapy.
2. Patients being treated with palliative intent in recurrent setting.
3. Radiation portals not overlapping the fields of previously irradiated region.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To document and evaluate change in quality of Life in patients receiving reRT for recurrence or second primary.  After Completion of Radiation therapy 
 
Secondary Outcome  
Outcome  TimePoints 
1.To evaluate changes in swallowing function, in patients receiving reRT.
2.To establish dosimetric relationship between Dysphagia Aspiration Related Structures and severity of swallowing dysfunction in patients receiving Re-RT.
3.To determine Incidence rate of acute and late toxicities associated with reRT.
4.To determine DFS/ local control rates/ OS rates from date of diagnosis of second primary/ recurrence.
5. To determine the pattern of disease progression post treatment in all patients. 
After Completion of Radiation therapy 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/06/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Head and neck cancers form a majority of the cancers of developing world accounting for 23% of all cancer in males and 6% in females in India.1 Aggressive locoregional treatment is offered for these patients. Despite this the survivors remain at risk of developing recurrences which are common within first 2 years and the cumulative estimated five year incidence of loco regional relapse is 29-31% in high risk patients.2-4 Main site of failure of Head neck cancers is locoregional.5 Also the risk of second cancers which is about 5% per year, the incidence being between 16-30%.6-8 Various factors affect the risk of recurrence and second cancers.

The toxicity and quality of life factors due to initial treatment may limit the ability to offer further radical treatment without increasing morbidity or affecting further the quality of life of these patients. These factors have to be considered while considering treatment decisions for treatment of these patients with a result that one or more modality may not be offered which otherwise would have been offered for patients with similar stage primary tumors.

The treatment of choice in a case of a recurrence or second neoplasm is salvage surgery. In case of inoperable and/or unresectable cases, other modalities could be considered including chemotherapy and radiation. Chemotherapy alone is essentially palliative and the results are quite dismal9 with response rates between 10% and 40% and median survivals of six to eight months and no long term survivors even with the best multidrug regimens10-13.

Radiotherapy is an important modality for primary treatment of head neck cancers and has been successfully used at various subsites with success comparable to the surgery and with an added advantage of organ preservation. Head and neck radiotherapy even for the primary tumor is challenging because of the anatomy and the number of critical organs that are present very close to the target area. Another factor is the late tissue toxicity. All these reduce the therapeutic ratio.

Concept of reirradiation with curative intent has been used with judicious case selection of recurrence / second primary by several institutions with varied success.14-21 Complication rates after reirradiation vary from 7%to 50% but are higher for reirradiation of sites like the nasopharynxor PNS due to their proximity to critical structures like brain, cranial nerves, and the orbits.15,22 The aspects that are evaluated prior to reirradiation and determining the dose constraints must be standardized. Due to the ability and availability to deliver precise and accurate radiotherapy using advanced delivery techniques like IMRT & IGRT, relatively better normal tissue sparing can be achieved. The study of these conformal techniques has been evaluated and found to give comparable outcomes although the acute toxicity was high.23

Various factors affect the decision for treatment. Factors related to the prior treatment as to the dose, fractionation, late effects and time interval since prior radiation, factors related to the patient like performance status, age, comorbidities and factors of the present tumor site, volume in previously irradiated region, ability to offer surgery and / or radiotherapy need to be assessed and correlated with the outcomes. Besides documentation of those who take treatment, their follow up to get an outcome would be reasonable. Besides documentation and reporting of the Quality of life is needed to assess the impact of benefit with reirradiation.

Swallowing dysfunction has been reported in 30-50% of patients of head and neck cancers treated with intensive nonsurgical therapies.22-24 About one third of dysphagic patients develop aspiration pneumonia requiring treatment, with mortality rates ranging between 20% and 65%.25 Although dysphagia improves over time in 32% of HNCPs, 48% of patients fail to report improvement in dysphagia -associated symptoms and in 20% of patients symptoms worsen overtime.26 Dysphagia may pre-exist therapy (14% [27] to 18% [28] of HNCPs) due to the obstruction by the tumour volume or infiltration of structures involved with swallowing. In the operative population, surgical extirpation of structures necessary for normal deglutition results in swallowing abnormalities. In the patients treated with radiotherapy (RT), dysphagia is secondary to damage of neural and soft tissues [29].

 

RT-induced swallowing dysfunction may occur both acutely during treatment and as a late effect of therapy. Radiation dose delivery to dysphagia–aspiration-related structures (DARSs), those anatomical structures that are critical to the swallowing function [30] has been shown to predict swallow outcome in a number of studies. DARS comprise of the superior, middle and inferior pharyngeal constrictor muscles, cricopharyngeus muscle, esophagus inlet muscles, cervical esophagus, base of tongue, supraglottic larynx and glottic larynx . Severity of dysphagia increase with the dose received by the pharyngeal constrictors (31) but it also increases with the volume of the pharyngeal constrictors irradiated (31,32,33). The volume of the middle pharyngeal constrictor muscle receiving 50 Gy (p = 0.04), the mean dose to this structure (p = 0.02) and to the supraglottic larynx (p = 0.04) were significantly associated with late swallowing problems. It has been seen that while treating orophryngeal cancer with IMRT technique, dose to superior pharyngeal constrictors and myo/geniohyoid complex should be monitored and constrained whenever possible .34 The volume of the larynx receiving >or=50Gy (p = 0.04 and p = 0.03, respectively) and volume of the inferior constrictor receiving >or=50Gy (p = 0.05 and p = 0.02, respectively) were significantly associated with both aspiration and stricture.33 

 

All these data are from reports on patients receiving primary therapy. In patients receiving re RT, Quality of life related to swallowing is already impaired due to prior 

therapies and  there is paucity of data regarding swallowing outcomes, doses that can be delivered without worsening swallowing outcomes and factors that predict 

worse swallowing outcomes.
 
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