| CTRI Number |
CTRI/2017/07/009114 [Registered on: 27/07/2017] Trial Registered Prospectively |
| Last Modified On: |
22/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
Use of radiation treatment after surgery for small Oral cancers. |
Scientific Title of Study
Modification(s)
|
Adjuvant Radiotherapy in Early Stage Oral Cancers (AREST) – a
prospective randomized control trial
|
|
Secondary IDs if Any
|
| Secondary ID |
Registry |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Sudhir V Nair |
| Address |
PS 269,
ACTREC,
Tata Memorial Center,
Kharghar
Navi Mumbai 410210
Mumbai
MAHARASHTRA
410210
India |
| Phone |
9769617780 |
| Fax |
912227405085 |
| Email |
sudhirvr@gmail.com |
|
Details Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Sudhir V Nair |
| Address |
PS 269,
ACTREC,
Tata Memorial Center,
Kharghar
Navi Mumbai 410210
Mumbai
MAHARASHTRA
410210
India |
| Phone |
9769617780 |
| Fax |
912227405085 |
| Email |
sudhirvr@gmail.com |
|
Details Contact Person
Public Query
Modification(s)
|
| Name |
Dr Sudhir V Nair |
| Address |
PS 269,
ACTREC,
Tata Memorial Center,
Kharghar
Navi Mumbai 410210
Mumbai
MAHARASHTRA
410210
India |
| Phone |
9769617780 |
| Fax |
912227405085 |
| Email |
sudhirvr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Center, Parel Mumbai |
|
Primary Sponsor
Modification(s)
|
| Name |
National Cancer Grid |
| Address |
Department of Atomic Energy, Government of India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 9 |
| Contact Person |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Krishnakumar Thankappan |
Amrita Institute of Medical Sciences |
Ponekkara AIMS PO
Kochi 682 041 Kerala
Ernakulam
|
04846681234
drkrishnakumart@yahoo.co.in |
| Dr Ashok Das |
Dr B Borooah Cancer Institute |
AK Azad Road Gopinath Nagar Rd Bishnu Rabha Nagar Guwahati Assam 781016
Kamrup
|
09957033212
akdas171@gmail.com |
| Dr Rajendra Toprani |
HCG Cancer Centre |
Sola Road
Science City Road Off
Sarkhej
Gandhinagar Hwy Sola Ahmedabad Gujarat 380060
Ahmadabad
|
6358888814
rajendratoprani@hotmail.com |
| Dr Rajesh A Kantharia |
Kailash Cancer Hospital & Research Center |
Muni Seva Ashram Goraj Waghodia Gujarat 391760
Vadodara
|
02668265300
rajesh.kantharia@greenashram.org |
| Dr Aseem Mishra |
Mahamana Pandit Madan Mohan Malaviya Cancer Centre |
MPMMCC, BHU Campus, Sundar Bagiya Colony, Sundarpur, Varanasi, Uttar Pradesh 221005
Varanasi
|
05422517699
draseemmishra@gmail.com |
| Dr Geetha muttath |
Malabar Cancer Centre |
Kodiyeri, Muzhikkara - MCC Rd, Illathaazha, Thalassery, Kerala 670103
Kannur
|
04902399203
geethasatheeshan@gmail.com |
| Dr Vijay Pillai |
Mazumdar Shaw Medical Center |
258A Hosur Road Anekal Taluk Bommasandra Industrial Area Bengaluru Karnataka 560099
Bangalore
|
18003090309
drvijaypillai@gmail.com |
| Dr Narayana Subramaniam |
Sri Shankara Cancer Hospital and Research Centre |
1st Cross, Shankara Matt Premises, Shankarapuram, Basavanagudi, Bengaluru, Karnataka 560004
Bangalore
|
08026981000
narayana.subramaniam@gmail.com |
| Dr Sudhir VR |
Tata Memorial Center |
Dr E Borges Rd
Parel
Mumbai 400012
Mumbai
|
912224177283
sudhirvr@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Amirita Institute of Medical Sciences |
Approved |
| BBCI Medical Ethics Committee |
Approved |
| HCG Multi Specialty Ethics Committee |
Approved |
| IEC-1, Tata Memorial Center |
Approved |
| Instituional Ethics Committee, MPMMCC and HBCH, TMC |
Approved |
| Kailash Cancer Hospital and Research Centre |
Approved |
| Malabar cancer centre Institutional Review Board |
Approved |
| Narayana Health EC |
Approved |
| Sri Shankara Cancer Hospital and Research Center Scientific Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Early stage oral tongue cancers |
| Patients |
Malignant neoplasm of floor of mouth |
| Patients |
Malignant neoplasm of gum |
| Patients |
Malignant neoplasm of other and unspecified parts of tongue |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Group II: Study arm (Post-operative adjuvant radiotherapy) |
Intervention in the study group (Group II) will be in the form of post-operative adjuvant radiotherapy starting within 8-weeks of primary surgery. The randomised patients will receive Adjuvant radiotherapy 60 Gy in 30 fractions for 30 days over 6 weeks as routinely prescribed according to TMC recommendations and timely implementing it within or by 8 weeks of surgery. |
| Comparator Agent |
Observation (Arm I) |
All patients with early stage tongue cancer will undergo surgery (Wide local excision of the tumor) with ipsilateral neck dissection at minimum. Subsequently, if eligible they will be randomised to Observation vs Adjuvant radiotherapy.In the Arm I, the patients will be observed as per the standard practice. They will be followed up once in three months for three years. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Post-operative early stage squamous cell carcinoma of oral cavity (Oral Tongue, Buccal Mucosa, Floor of mouth).
(pT1, pT2, N0 as defined in the AJCC Classification 8th edition.
pT2 is defined in AJCC 8th edition as
i. Tumor < 2cm and depth of invasion > 5mm and ≤ 10mm.
ii. Tumor > 2cm but ≤ 4cm and depth of invasion (DOI) ≤ 10mm.)
2. Adequate surgery (Defined as wide local excision of primary tumor with tumor free margin ≥ 5mm and ipsilateral selective neck dissection addressing levels I-III at minimum.)
3. Written informed consent.
4. Age ≥18 years
5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
6. Depth of invasion (DOI) ≥ 5 mm.
7. Compliance to therapy and follow-up
8. Interval from surgery to adjuvant radiotherapy ≤ 8 weeks
|
|
| ExclusionCriteria |
| Details |
1. pT3/pT4 (as specified in the AJCC 8th edition).
2. Depth of invasion < 5mm.
3. Any neck nodal metastasis with or without extra nodal extension.
4. Tumor free margin < 5 mm
5. Non-squamous histology
6. Pregnant woman
7. Prior h/o any other malignancy in the last five years
8. Prior therapeutic irradiation of the head and neck.
9. Presence of HIV infection
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Loco-regional recurrence free survival |
Three years from the date of surgery for the index lesion. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Acute and long-term Radiation toxicity rate with CTCAE v5.0 |
At 3 monthly regular follow up interval |
| Disease free survival |
Calculated as difference of date of randomization to date of first recurrence or relapse, second primary or death |
| Overall survival |
Date of Randomization to date of death from any cause |
| Quality of life with on (EORTC QLQ H&N-35) and EORTC QLQ-C 30 |
First before starting RT and subsequently every three months after RT. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="392"
Sample Size from India="392" |
|
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
02/08/2018 |
| Date of First Enrollment (Global) |
No Date Specified |
|
Estimated Duration of Trial
|
Years="7"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
None yet. Details of the trial related publications will be provided as when it happens. |
Brief Summary
Modification(s)
|
Oral cancer is one of the commonest cancer affecting men in
India. Surgery is the preferred initial mainstay of treatment for these
patients in our institute. The predominant pattern of failure for oral cancers
remains loco-regional recurrence. Various retrospective reports including data
from our own institute suggests that depth of invasion is an important factor
affecting prognosis in early stage oral cancers. Some centers therefore, advice
adjuvant radiotherapy for these tumors based on tumor thickness / depth of
invasion alone even in the absence of other adverse prognostic factors.
However, no direct evidence exists for the effectiveness of radiotherapy in
improving disease-related outcomes in patients with depth of invasion as the
only adverse prognostic factor. Given the lack of evidence, none of the
international guidelines recommend post-operative adjuvant radiotherapy in
early stage oral tongue cancer based on depth of invasion alone.
The aim of this study is therefore to assess the benefit of
post-operative adjuvant radiotherapy in patients with an early stage oral
squamous cell carcinoma (OSCC). The hypothesis is that postoperative adjuvant
radiotherapy would significantly reduce the risk of loco-regional recurrence in
patients with tumor thickness ≥5 mm compared to observation alone after
definitive surgical treatment of the primary and the neck. |
