| CTRI Number |
CTRI/2017/09/009921 [Registered on: 26/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
22/09/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A prospective study of therapeutic outcome in patients with locally advanced Head and Neck Cancers treated with chemo-radiation in combination with Nimorazole |
|
Scientific Title of Study
|
A prospective study of therapeutic outcome in locally advanced Head and Neck Cancers treated with chemo-radiation and the hypoxic radio- sensitizer Nimorazole |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anoop R |
| Designation |
Asst. Professor |
| Affiliation |
Amrita Institute of Medical Sciences and Research, Kochi, Kerala |
| Address |
Department of Radiation Oncology,
Amrita Institute of Medical Sciences and Research, Kochi, Kerala
Ernakulam
KERALA
682041
India |
| Phone |
04842801234 |
| Fax |
|
| Email |
anoopr@aims.amrita.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anoop R |
| Designation |
Asst. Professor |
| Affiliation |
Amrita Institute of Medical Sciences and Research, Kochi, Kerala |
| Address |
Department of Radiation Oncology,
Amrita Institute of Medical Sciences and Research, Kochi, Kerala
Ernakulam
KERALA
682041
India |
| Phone |
04842801234 |
| Fax |
|
| Email |
anoopr@aims.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aswin George Abraham |
| Designation |
Resident |
| Affiliation |
Amrita Institute of Medical Sciences and Research, Kochi, Kerala |
| Address |
Department of Radiation Oncology,
Amrita Institute of Medical Sciences and Research, Kochi, Kerala
Ernakulam
KERALA
682041
India |
| Phone |
04842801234 |
| Fax |
|
| Email |
aswinga22042@aims.amrita.edu |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences and Research, Ponekkara, Kochi, Kerala, India |
|
|
Primary Sponsor
|
| Name |
Amrita Institute of Medical Sciences and Research |
| Address |
Department of Radiation Oncology, Amrita Institute of Medical Sciences and Research, Ponekkara, Kochi |
| 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 Anoop R |
Amrita Institute of Medical Sciences and Research |
Department of Radiation Oncology, Amrita Institute of Medical Sciences and Research, Ponekkara, Kochi
Ernakulam
KERALA |
04842801234
anoopr@aims.amrita.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita Institute of Medical Sciences and Research Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Locally Advanced Oro-pharyngeal, Laryngeal and Hypopharyngeal cancer patients eligible for concurrent chemo-radiation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Concurrent Chemo-Radiation |
Locally advanced Oropharyngeal, laryngeal and Hypopharyngeal cancers will be given the gold standard of care with concurrent chemotherapy (weekly platinum) and Radiation |
| Intervention |
The hypoxic radio-sensitizer Nimorazole will be given along with concurrent chemo-radiation |
Locally advanced Oropharyngeal, laryngeal and Hypopharyngeal cancers will be given the gold standard of care with concurrent chemotherapy (weekly platinum) and Radiation along with daily Nimorazole 1200mg/sq metre of BSA prior to radiation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1)Tumour classified as stage III-IV located in oropharynx, hypopharynx and larynx according to the TNM classification.
2) Histopathological diagnosis of invasive squamous cell carcinoma in the primary tumour.
3) Age > 18 years and < 75 years.
4) Informed consent according to the Helsinki declaration and institutional regulations.
5) The patient must be candidate for external beam radical radiotherapy, and must be expected to accomplish the treatment.
6) Performance status 0-2 according to WHO criteria.
7) The patient should not have symptoms of peripheral neuropathy assessed by clinical examination.
8) Normal function of liver and kidney by routine laboratory examinations.
9) The patient must not be pregnant. |
|
| ExclusionCriteria |
| Details |
1) Distant metastases.
2) The patient should not have any other co-morbidities or conditions that could be expected to influence the outcome of treatment, or complicate the assessment or the treatment follow-up, or (apart from the present disease) reduce the life expectancy.
3) Surgical excision (except biopsy), prior or planned (including elective neck dissection).
4) The existence of synchronous multiple malignancies (not leucoplakia).
5) Use of Vitamin K agonists (since 5-nitroimidazoles are inhibitors of CYP2C9). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study Loco-regional Control of disease |
5 years from completion of definitive treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Overall Survival
2) Test Osteopontin as a marker for hypoxia to predict efficacy of Nimorazole.
3) Identify a correlation between sensitivity to radiation and p53 mutations in hypoxic tumours. |
5 years from completion of definitive treatment |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
04/01/2016 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of the present study is to improve the effect of radiotherapy given to patients with locally advanced head and neck carcinoma, who are candidates for primary chemo-radiation therapy alone. This rationale has been recently tested in a Phase II (DAHANCA-18 study) setting with good results. The protocol seeks to test the hypothesis that radiotherapy of head and neck carcinoma can be improved by hypoxic modification of tumours using nimorazole as a hypoxic radiosensitizer in conventional treatment strategies. The study will evaluate the loco-regional tumour control after chemo-radio-therapy, acute toxicity, disease-free and overall survival, and the early and late treatment related morbidity. This will be correlated with a translational component, where the treatment outcome will be compared with specific tumour characteristics (HPV status and p53 status) as well as circulating hypoxia markers present in plasma. |