| CTRI Number |
CTRI/2025/09/094270 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to find out if radiotherapy alone or radiotherapy with chemotherapy works better after surgery in people with advanced oral cancers |
|
Scientific Title of Study
|
A Phase III Randomized Controlled Trial of Adjuvant RT Alone Versus Concurrent Chemoradiotherapy After Neoadjuvant Treatment in Borderline Resectable Oral Cavity Cancers (RAdiAN) |
| Trial Acronym |
RAdiAN |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anuj Kumar S |
| Designation |
Associate Professor |
| Affiliation |
ACTREC, Tata Memorial Centre |
| Address |
Dept of Radiation Oncology, ACTREC, Sector 22,Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9946416480 |
| Fax |
|
| Email |
akumars@actrec.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Anuj Kumar S |
| Designation |
Associate Professor |
| Affiliation |
ACTREC, Tata Memorial Centre |
| Address |
Dept of Radiation Oncology, ACTREC, Sector 22,Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9946416480 |
| Fax |
|
| Email |
akumars@actrec.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Anuj Kumar S |
| Designation |
Associate Professor |
| Affiliation |
ACTREC, Tata Memorial Centre |
| Address |
Dept of Radiation Oncology, ACTREC, Sector 22,Kharghar, Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9946416480 |
| Fax |
|
| Email |
akumars@actrec.gov.in |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Centre,
Dr. E. Borges Road, Parel
Mumbai 400012
Maharashtra
India |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Dr E Borges Road, Parel, Mumbai-400012,India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sun Pharma Science Foundation |
8C, 8th Floor, Hansalaya Building,
15-Barakhamba Road,
Connaught Place, New Delhi 110001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anuj Kumar S |
ACTREC, Tata Memorial Hospital |
Room No: 23, Dept of Radiation Oncology, Proton Therapy Centre, ACTREC, Sector 22, Kharghar, Navi Mumbai-410210
Raigarh
MAHARASHTRA |
9946416480
akumars@actrec.gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-III, Tata Memorial Centre |
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. Ayurveda Condition: NO, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Adjuvant RT with concurrent chemotherapy | 60 to 64 Gy/30 to 32 # over 6 to 7 weeks with concurrent chemotherapy as per physicians choice | | 2 | Intervention Arm | Procedure | - | Adjuvant RT alone | (Procedure Reference: Established literature, Procedure details: 60 to 64 Gy/ 30 to 32 # over 6 to 7 weeks)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18 and 70 years
2. Karnofsky Performance Score (KPS) not less than 70
3. Biopsy-proven borderline resectable oral squamous cell carcinoma (OSCC)
4. Baseline imaging available
5. Received two or more cycles of neoadjuvant systemic therapy followed by surgery
6. Complete histopathology details available, including:
-Tumour size
-Grade
-Margin status
-Depth of invasion
-Perineural invasion
-Nodal involvement
-Extranodal extension
-Pathological response to neoadjuvant therapy
7. Fit for concurrent chemotherapy defined by the following thresholds:
-Hematological: Absolute neutrophil count (ANC) not less than 1000/µL; Platelet count not less than 100,000/µL
-Renal: Creatinine clearance not less than 60 mL/min OR serum creatinine not more than 1.5 mg/dL
-Hepatic: AST and ALT not more than 2.5 times the upper limit of normal; Total bilirubin not more than 1.5 times the upper limit of normal
8. No active uncontrolled infections or severe comorbidities |
|
| ExclusionCriteria |
| Details |
1. Positive margins or extranodal extension (ENE) on histopathology, or ENE detected on baseline imaging
2. Recurrent or second primary cancers
3. Prior radiotherapy or chemoradiotherapy
4. Incomplete HPR information
5. Presence of distant metastasis
6. Unresolved grade III or IV toxicities related to neoadjuvant systemic therapy at the time of randomization |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine whether adjuvant RT alone is non-inferior to adjuvant CTRT in achieving 3-year DFS in patients with borderline resectable oral cancers treated with neoadjuvant systemic therapy and surgery. |
-Baseline: Post-surgery, before starting adjuvant therapy
-End of RT/CTRT: At 6–7 weeks (completion of adjuvant treatment)
-Follow-up (Year 1-2): Every 3 months
-Follow-up (Beyond 2 years): Every 6 months till final 3 year DFS assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-To compare 3-year overall survival (OS), locoregional recurrence-free survival (LRRFS), and distant metastasis-free survival (DMFS) between the two arms.
-To assess acute and late toxicities.
-To measure quality of life outcomes using the EORTC QLQ-C30, EORTC QLQ-H&N43, and EQ-5D-5L questionnaires.
-To assess response to neoadjuvant treatment using molecular biomarkers such as gamma-H2AX, apoptosis markers, and cell cycle analysis.
-To correlate molecular markers of response with long-term clinical outcomes.
-To evaluate response to neoadjuvant chemotherapy using imaging biomarkers derived from radiomics and machine learning models.
-To analyse baseline and interim imaging to assess treatment response and correlate with long-term outcomes across both study arms.
-To compare radiation-induced toxicity between the adjuvant radiotherapy alone arm and the adjuvant chemoradiotherapy arm using gamma-H2AX assays. |
-Primary endpoint (disease-free survival): assessed at 3 years from randomization
-Overall survival, locoregional control, and distant metastasis-free survival: assessed at 3 and 5 years
-Toxicity: monitored weekly during treatment and at each follow-up visit (every 3 months for 2 years, then every 6 months up to 5 years)
-Quality of life: assessed at baseline, end of radiotherapy, and at follow-up visits
-Biomarker studies: after neoadjuvant therapy, before radiotherapy, and within 48 hours after completion of radiotherapy
-Imaging: baseline, post-neoadjuvant therapy, and annually during follow-up |
|
|
Target Sample Size
|
Total Sample Size="376"
Sample Size from India="376"
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)
|
15/09/2025 |
| 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)
|
Open to Recruitment |
| 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
|
This is a Phase III randomized controlled trial designed to evaluate whether adjuvant radiotherapy alone is non-inferior to adjuvant chemoradiotherapy in patients with borderline resectable oral cavity squamous cell carcinoma who have received neoadjuvant systemic therapy followed by surgery. Eligible patients will be randomized within eight weeks of surgery to receive either adjuvant radiotherapy alone (60–64 Gy in 30–32 fractions) or adjuvant radiotherapy with concurrent chemotherapy. The primary endpoint is three-year disease-free survival. Secondary endpoints include overall survival, locoregional recurrence-free survival, distant metastasis-free survival, acute and late toxicities, and quality of life outcomes assessed using validated questionnaires. Translational research will be conducted to evaluate molecular biomarkers and imaging correlates of treatment response and toxicity. A total of 376 patients will be enrolled across Tata Memorial Hospital and ACTREC, Mumbai. The study aims to refine postoperative treatment strategies, reduce unnecessary chemotherapy, and improve quality of life without compromising survival outcomes. |