| CTRI Number |
CTRI/2024/07/071188 [Registered on: 24/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Two drug therapy versus three drug therapy in resectable locally advanced oral cavity cancer |
|
Scientific Title of Study
|
A Phase 2 Open label Randomised Controlled Trial Comparing Modified TPF with Docetaxel-Platinum Regimen as Neoadjuvant Chemotherapy in Locally Advanced Resectable Oral Cavity Cancer |
| Trial Acronym |
NeoORAL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akash Kumar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Medical Oncology
Academic Block
National Cancer Institute
AIIMS Jhajjar campus
Badsa
Jhajjar
HARYANA
124105
India |
| Phone |
01251274776 |
| Fax |
|
| Email |
akashjha08@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aakanksha Naik |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Medical Oncology
AIIMS
New Delhi
South
DELHI
110029
India |
| Phone |
9687101931 |
| Fax |
|
| Email |
aakankshanaik96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akash Kumar |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Medical Oncology
Academic Block
National Cancer Institute
AIIMS Jhajjar campus
Badsa
HARYANA
124105
India |
| Phone |
01251274776 |
| Fax |
|
| Email |
akashjha08@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS, New Delhi |
| Address |
Sri Aurobindo Marg,
Ansari Nagar,
Ansari Nagar East,
New Delhi
110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akash Kumar |
All India Institute of Medical Sciences |
Department of Medical Oncology, 2nd floor, Dr. B.R.A.IRCH
New Delhi
South
DELHI |
01251274776
akashjha08@yahoo.com |
| Dr Akash Kumar |
National Cancer Institute AIIMS |
Department of Medical Oncology,
1st floor,
National Cancer Institute
AIIMS - Jhajjar campus
Badsa, Jhajjar, Haryana
Jhajjar
HARYANA |
01251274776
akashjha08@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Institute Ethics Committee for Post Graduate Research |
Approved |
|
|
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 |
Docetaxel-Cisplatin |
Docetaxel @ 75 mg per square metre, administered as a 1 hour intravenous infusion in normal saline over 1 hour (day 1)
CDDP @ 75 mg per square metre, administered as an intravenous infusion in normal saline over a period of 2 hours (day 1)
Supportive care
Administered every 3 weeks for total 4 cycles
|
| Intervention |
Modified TPF |
Docetaxel @ 50 mg per square metre, administered as a 1 hour intravenous infusion in normal saline over 1 hour (day 1)
CDDP @ 50 mg per square metre, administered as an intravenous infusion in normal saline over a period of 2 hours (day 1)
5-Fluorouracil @ 2400 mg per square metre as continuous intravenous infusion over day 1 and 2 (48 hours)
Supportive care
Every 2 weeks for total 6 cycles
Participants will receive prophylactic growth stimulating factors (G-CSF) 3-5 mcg/kg - Day 3 onwards for 5 days.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Histologically confirmed squamous cell carcinoma of the oral cavity
Patients with a resectable lesion, with clinical stage III or IVA disease (T3N0 or T1-3N1-2M0 or T4aN0-2M0 according to Union for International Cancer Control [2018]).
ECOG PS 0-1
Meeting the following standard values of general laboratory tests completed within 7 days prior to randomization and values are within the parameters required by the protocol:
a) WBC count more than 4,000/μL, hemoglobin more than 8 g/L, platelet count more than 100,000/μL
b) ALT and AST less than 2.5× the upper limit of normal
c) Total bilirubin less than 1.5× the upper limit of normal
d) Serum creatinine less than 1.5× the upper limit of normal
Written informed consent.
|
|
| ExclusionCriteria |
| Details |
Distant metastasis or other cancers
Have undergone surgery involving primary tumor or lymph nodes (except diagnostic biopsy)
Have received any prior radiotherapy or chemotherapy
Have had other malignancies within 5 years
Have creatinine clearance less than 60 mL/min.
Cisplatin ineligible patients
Unstable angina within 3 weeks, or with a history of myocardial infarction within last 6 months
Pregnant or breastfeeding females or those not willing for contraception |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare between the two study arms the overall response rates after neoadjuvant chemotherapy |
12-14 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate the rate of pathologic complete response (pCR) in both arms (primary tumor & node) |
16 weeks |
| Evaluate major pathological response in primary tumor in both arms |
16 weeks |
Compare the accuracy of contrast-enhanced CT vs 18FDG-PET-CT in predicting complete pathological & major pathological response post NACT in both arms
|
16 weeks |
| Evaluate the incidence & severity of adverse events according to the CTCAE v5.0 criteria in both arms |
2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks in Arm B
3 weeks, 6 weeks, 9 weeks, 12 weeks in Arm A |
| Assess patient-reported outcomes using the EORTC H&N 43 & EORTC QLQ-C30 questionnaire in both study groups. |
0 weeks, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks in Arm B
0 weeks, 3 weeks, 6 weeks, 9 weeks in Arm A |
| Assessment of tumor shrinkage pattern & margin sterility, pre & post NACT |
16 weeks |
| To study genetic signatures of tumors with favourable as well as unfavourable pathological response |
20 weeks |
|
|
Target Sample Size
|
Total Sample Size="204"
Sample Size from India="204"
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)
|
29/07/2024 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study intends to find a regimen which will be more efficacious yet tolerable in comparison to a platinum-taxol based two drug regimen. This new regimen, if found to be superior may replace the standard 3 weekly TPF regimen in different settings. It has been shown in multiple studies that three drug regimen (standard TPF) although efficacious is associated with significant incidence of adverse events thus, limiting its use in clinics. Besides, a 5 day infusion protocol is another deterrent due to logistic issues of limited indoor beds in hospitals. The selection of patient population of resectable oral cavity cancers is based on the newly generated interest on less demolitive surgery post NACT, including mandibular preservation.
|