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
|
|
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
|
|
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. |