| CTRI Number |
CTRI/2013/04/003568 [Registered on: 17/04/2013] Trial Registered Retrospectively |
| Last Modified On: |
18/04/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
NECK DISSECTION VERSUS OBSERVATION IN EARLY ORAL CAVITY CANCER |
|
Scientific Title of Study
|
ELECTIVE VERSUS THERAPEUTIC NECK DISSECTION IN THE TREATMENT OF EARLY NODE NEGATIVE SQUAMOUS CELL CARCINOMA OF THE ORAL CAVITY |
| Trial Acronym |
N0 Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT00193765 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anil K Dcruz |
| Designation |
MS., DNB, FRCS (HON) |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital, Dr. E. Borges Road, Parel, Mumbai - 400 012 India
Mumbai MAHARASHTRA 400012 India |
| Phone |
022-24177000 |
| Fax |
|
| Email |
docdcruz@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anil K Dcruz |
| Designation |
MS., DNB, FRCS (HON) |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital, Dr. E. Borges Road, Parel, Mumbai - 400 012 India
Mumbai MAHARASHTRA 400012 India |
| Phone |
022-24177000 |
| Fax |
|
| Email |
docdcruz@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Anil K Dcruz |
| Designation |
MS., DNB, FRCS (HON) |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital, Dr. E. Borges Road, Parel, Mumbai - 400 012 India
Mumbai MAHARASHTRA 400012 India |
| Phone |
022-24177000 |
| Fax |
|
| Email |
docdcruz@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital, Dr. E. Borges Road, Parel, Mumbai - 400 012 India |
| 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 Anil K D cruz |
Tata Memorial Hospital |
CRS dept, annex bldg, 5 th floor, Tata Memorial Hospital, Dr. E. Borges Road, Parel, Mumbai - 400 012 India Mumbai MAHARASHTRA |
022-24177000
docdcruz@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
T1, T2 oral cavity cancer with node negative neck, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Early oral cancer
Node negative neck |
Elective Vs Therapeutic neck dissection in early oral cancer
Elective neck dissection in early node negative oral cancers |
| Intervention |
surgery/anaesthesia |
Procedure: Elective Vs Therapeutic neck dissection in early oral cancer |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Histologically proven T1 or T2 N0 M0 (clinical) squamous cell carcinoma of the buccal mucosa, lower alveolus, oral tongue and floor of mouth.
2. Surgery is the preferred treatment and the primary tumor can be excised with clear margins via the per-oral route.
3. No history of a prior malignancy in the head and neck region.
4. No prior malignancy outside the head and neck region in the preceding 5 years.
5. Patient will be reliable for follow-up
6. Age> 18 years and < 75 years.
7. No significant co-morbid conditions - ASA grade II and I.
8. Understands the protocol and is able to give informed consent.
|
|
| ExclusionCriteria |
| Details |
. Prior radiotherapy or surgery for malignancy in the head and neck region.
2. Non squamous cell carcinomas of the oral cavity.
3. Upper alveolus and palatal lesions where there is a possibility of retropharyngeal node involvement.
4. Per-oral excision of tumor will compromise margins in the opinion of the treating surgeon.
5. Significant co-existing pre-malignant conditions like erytho-leucoplakia and oral sub mucous fibrosis that in the opinion of the clinician would interfere in the planned treatment management of the patient.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To demonstrate whether elective neck dissection (END) is equal or superior to the wait and watch policy i.e. therapeutic neck dissection (TND) in the management of the clinically No neck in early T1 /T2 cancers of the oral cavity. |
overall survival |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Does USG examination have any role in routine initial workup of node negative patient? How are patients followed up –does USG have role or clinical examination sufficient. Is assessment of tumor thickness by surgeon at time of initial surgery accurate –Is there correlation between tumor thickness as measured grossly by surgeon, at FS versus final HPR. Identify HPR prognostic factors in primary that may help identify sub-set of patients at increased risk of cervical metastasis. |
5 years |
|
|
Target Sample Size
|
Total Sample Size="710" Sample Size from India="710"
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)
|
07/01/2004 |
| 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="11" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Cervical metastasis is the single most important prognostic factor in head and neck cancers. Appropriate management of the neck is therefore of paramount importance in the treatment of these cancers. While it is obvious that the positive neck must be treated, controversy has always surrounded the clinically node negative neck with respect to the ideal treatment policy.The situation is difficult with regards to early cancers of the oral cavity (T1/T2). These cancers are usually treated with surgery where excision is through the per-oral route. Elective neck dissection in such a situation is an additional surgical procedure with its associated costs, prolonged hospitalization and may be unnecessary in as high as 80% of patients who finally turn out to be pathologically node negative. Should the neck be electively treated or there be a wait and watch policy? Current practice is that the neck is always addressed whenever there is an increased propensity to cervical metastasis or when patient follow-up is unreliable.
There is clearly a need therefore for a large randomized trial that will resolve the issue either way once and for all.
Primary objective:
To demonstrate whether elective neck dissection (END) is equal or superior to the wait and watch policy i.e. therapeutic neck dissection (TND) in the management of the clinically No neck in early T1 /T2 cancers of the oral cavity.
Secondary Objective:
1. Does Ultrasound examination have any role in the routine initial workup of a node negative patient? 2. How are patients ideally followed up –does sonography have a role or is clinical examination sufficient. 3. Is assessment of tumor thickness by the surgeon at the time of initial surgery accurate –Is there a correlation between tumor thickness as measured grossly by the surgeon, at frozen section versus final histopathology. 4. Identify histological prognostic factors in the primary that may help identify a sub-set of patients at an increased risk of cervical metastasis.
|