| CTRI Number |
CTRI/2021/06/034033 [Registered on: 07/06/2021] Trial Registered Prospectively |
| Last Modified On: |
04/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A single blind randomised controlled trial comparing submandibular gland plus parotid sparing versus parotid sparing alone using volumetric modulated arc therapy in patients with head and neck cancer squamous cell carcinomas |
|
Scientific Title of Study
|
Submandibular gland sparing plus parotid sparing versus parotid sparing alone using volumetric modulated arc therapy (VMAT) in head and neck squamous cell carcinomas - a single blind phase 3 randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SHYAMA PREM S |
| Designation |
Additional Professor |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Regional cancer centre (RCC)
Jawaharlal institute of postgraduate medical education and research
Dhanvanthri nagar
Gorimedu
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9787814215 |
| Fax |
- |
| Email |
shyamaprems1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MUTHUVEERAPPAN S |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Regional cancer centre (RCC)
Jawaharlal institute of postgraduate medical education and research
Dhanvanthri nagar
Gorimedu
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9500595396 |
| Fax |
- |
| Email |
muthuveerappan100796@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MUTHUVEERAPPAN S |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research |
| Address |
Regional cancer centre (RCC)
Jawaharlal institute of postgraduate medical education and research
Dhanvanthri nagar
Gorimedu
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9500595396 |
| Fax |
- |
| Email |
muthuveerappan100796@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
Jawaharlal institute of postgraduate medical education and research
Dhanvanthri nagar
Gorimedu
Puducherry |
| Type of Sponsor |
Research institution and hospital |
|
|
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 SHYAMA PREM S |
Jawaharlal institute of postgraduate medical education and research |
No.7, Regional Cancer Centre (RCC),
Department of Radiation Oncology, Jawaharlal institute of postgraduate medical education and research
Dhanvanthri nagar
Gorimedu
Pondicherry
PONDICHERRY |
9787814215
shyamaprems1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Parotid sparing alone |
Patients with head and neck cancer receiving only parotid sparing volumetric modulated arc therapy everyday except Saturday and Sunday over a period of 7 weeks with 3 weekly concurrent chemotherapy |
| Intervention |
Submandibular plus parotid sparing |
Patients with head and neck cancer receiving submandibular gland plus parotid sparing volumetric modulated arc therapy everyday except Saturday and Sunday over a period of 7 weeks with 3 weekly concurrent chemotherapy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients over 18 years of age
2. Patients with ECOG performance status 0 - 2
3. Patients of squamous cell carcinoma of the
head and neck planned for radical radiation with or without concurrent chemotherapy treated with volumetric modulated arc radiotherapy |
|
| ExclusionCriteria |
| Details |
1. Patients with previous history of radiotherapy to head and neck
2. Patients with T1N0M0 carcinoma glottis
3. Patients with carcinoma of the head and
neck in whom the submandibular glands are enclosed completely in the clinical target volume.
4. Tumour involvement of both the submandibular glands
5. Pre–existing salivary gland disease
6. Previous or concurrent illness that would
compromise completion of treatment or
follow-up
7. Patient receiving prophylactic amifostine or pilocarpine |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of sparing the submandibular gland on patient reported outcomes measured subjectively using xerostomia questionnaire XQ in head and neck cancer patients receiving Submandibular and Parotid sparing versus Parotid sparing using Volumetric modulated arc therapy VMAT |
Pre radiation as baseline and at 3 months and at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of sparing the submandibular gland on salivary gland function measured objectively by measuring the unstimulated and stimulated salivary secretion by using sialometry |
Pre radiation as baseline and at 3 months and at 6 months |
| To assess the effect of sparing the submandibular gland on salivary gland function measured objectively using salivary scintigraphy |
Pre radiation as baseline and at 3 months and at 6 months |
| To assess the proportion of patients developing acute and late side effects of salivary gland radiation using acute and late RTOG toxicity scoring criteria |
Acute RTOG toxicity after every 5 fractions of radiation and at 6 weeks post radiation
Late RTOG toxicity will be assessed at 6 months post radiation |
| To assess the proportion of patients developing acute and late side effects of salivary gland radiation using the CTCAE version 5.0 |
Acute toxicity after every 5 fractions and at 6 weeks post radiation
Late CTCAE toxicity will be assessed at 6 months post radiation |
| To compare the quality of life in both arms using EORTC QOL 30 and EOTC QOL 35 questionnaire version 3.0 |
Pre radiation as baseline and at 3 months and at 6 months |
| To compare the response of the tumour to radiation in both arms, assessed by CECT head and neck 3 months post radiation using the RECIST criteria |
Response assessment using PETCT scan at 3 months |
| To compare the locoregional control in both arms assessed by CECT head and neck 6 months’ post radiation |
Locoregional recurrence will be assessed at 6 months post radiation |
| To assess the progression free survival and overall survival in both arms |
At 6 months |
| To assess the dosimetric parameters of the VMAT plans in both arms |
Dosimetric parameters will be analysed at the completion of study in both arms |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
11/06/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
We will publish the results of the study in International journals so that this information can be spread to oncologists worldwide. We will also implement reducing the dose to the submandibular gland in our day to day planning. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Radiation causes impairment of salivary gland function characterized by alteration of the volume, consistency, and pH of the secreted saliva. Saliva changes from thin, serous, neutral pH secretions to thick, tenacious and acidic secretions leading to dry mouth, sore throat, oral discomfort or pain, altered taste, difficulty in speaking, chewing or swallowing, changes in voice quality and an increased risk of dental caries. This can ultimately lead to poor nutritional intake and weight loss. As a result, the quality of life (QoL) of the head and neck cancer survivors reduces significantly post radiation treatment. Acute radiation induced xerostomia starts in the early phases of radiation treatment, usually in the first week, characterized by a 50% to 60% decrease in salivary flow. Late radiation induced xerostomia starts around 6 weeks after completion of radiation and the salivary flow diminishes to about 20%. Sparing of the salivary glands is necessary to minimize xerostomia in head and neck cancer patients. Though sparing the parotid glands has contributed significantly to a decrease in the incidence of radiation induced xerostomia it has inconsistently translated to subjective improvements in xerostomia. Reducing the dose to the submandibular glands in patients undergoing head and neck radiotherapy can augment the effect of parotid sparing IMRT in preventing xerostomia. However, they are conventionally not spared due to the concern that target coverage to the tumour area may be compromised. In a study by Hoyne etal, it was possible to reduce the mean dose to the contralateral submandibular gland to an acceptable dose of ≤39 Gy without compromising on the target volume coverage. In our institution we routinely spare both the parotid glands. We do not purposefully make an attempt to spare the submandibular gland due to the concerns of underdosing the tumor and risking recurrence. Hence we decide to conduct a single blind randomised controlled trial comparing submandibular gland plus parotid sparing versus parotid sparing alone using volumetric modulated arc therapy in patients with head and neck cancer. We are evaluating the effect of submandibular sparing on patient reported outcomes subjectively and salivary function objectively. |