Oral CancerPhase 3SurVICNCT06737822
Upfront Surgery Vs Induction Chemotherapy Followed By Surgery In Oral Cancers:
A Phase 3 study testing TPF or TPX Regimen (2# ICT) --> Surgery and Adjuvant Treatment and Surgery and Adjuvant Treatment in people with Oral Cancer and Head and Neck Neoplasms, run by All India Institute of Medical Sciences, Jodhpur at 7 sites in India.
Trial summary
A majority of oral cancer patients in India present in the advanced stage hence tend to have poor oncological outcomes. Chemotherapy has been associated with improved oncological outcomes in various cancers but its role in oral cancer is not well defined in curative setting apart from radio sensitization. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Oral Cancer, Head and Neck Neoplasms
- What is being tested?
- TPF or TPX Regimen (2# ICT) --> Surgery and Adjuvant Treatment and Surgery and Adjuvant Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 7 sitesIndia
- Study dates
- 20 Dec 2024to Oct 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed, treatment naïve, biopsy or cytology proven OSCC
- Clinical Stage cT1-4a, cN2-N3**, M0- as per UICC 2018
- No evidence of distant metastases on chest x-ray and/or CT Thorax
- ECOG PS 0-2
- No contraindication to Cisplatin or radiotherapy***
- Patients eligible for definitive curative intent treatment after discussion in multidisciplinary tumour board
- Adequate organ function at time of participation, defined as Haematological: Haemoglobin > 9gm/dl, ANC ≥ 1500/cmm3, Platelet ≥100000/cmm3 Liver Function test: Bilirubin ≤2 x upper limit normal (ULN), AST/ALT/ ALP ≤ 2.5 x ULN Renal Function test: Creatinine ≤ 1.5 ULN, Creatinine Clearance ≥60 ml/min.
Who cannot join
- Pregnant
- History of moderate to severe hearing loss.
- History of previous malignancy excluding non-melanoma skin cancers or cervical carcinoma in situ.
- Documented Weight loss of more than 15% in the last 6 months.
- Patients with known HIV, hepatitis B or C infection.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
India7 sites, 7 recruiting
- Not yet recruiting
All India Institute of Medical Sciences, Bathinda
Bathinda
Rohit Mahajan
- Not yet recruiting
All India Institute of Medical Sciences, Bhubaneshwar
Bhubaneswar, Odisha, 751019
Dillip Mudully
- Not yet recruiting
Shri Mahant Indresh Hospital, Dehradun
Dehradun
Pankaj K Garg
- Recruiting
All India Institute of Medical Sciences, Jodhpur
Jodhpur, Rajasthan, 342005
Dharma R Poonia, MS DNB
Dharma R Poonia, MS DNB
- Not yet recruiting
King George's Medical University
Lucknow
Vijay Kumar
- Not yet recruiting
All India Institute of Medical Sciences, Rishikesh
Rishikesh
Amit Sehrawat
- Not yet recruiting
Geetanjali Medical College, Udaipur
Udaipur
Ashish Jhakhetiya
About this study
Official title: Upfront Surgery Vs Induction Chemotherapy Followed By Surgery In Oral Cavity Squamous Cell Cancers With Advanced Nodal Disease (SurVIC Trial): A Phase 3 Multicentric Randomized Controlled Trial
A majority of oral cancer patients in India present in the advanced stage hence tend to have poor oncological outcomes. Chemotherapy has been associated with improved oncological outcomes in various cancers but its role in oral cancer is not well defined in curative setting apart from radio sensitization. Attempted trials of neoadjuvant chemotherapy failed to show oncological advantage despite an excellent response rate, in part due to poor patient selection. Patients with a biologically aggressive disease are more likely to benefit, hence we intend to find out the oncological advantage of adding induction chemotherapy to oral squamous cell cancer with advanced nodal disease (N2-N3).
Earlier studies suffered from their heterogeneous patient population- all head and neck subsites together and included a spectrum ranging from early- stage operable cases to inoperable cancer. Due to such patient selection, the intended results were never met. The current study is intended to study the role of chemotherapy in curable patients who are most likely to benefit (biologically aggressive and advanced stage of presentation).
Read more
Objective
Primary:
To study the 2 year disease free survival by adding induction chemotherapy before surgery in patients of oral cancer with advanced nodal disease as compared to upfront surgery.
Secondary:
To assess treatment related outcomes between the treatment arms- Response rate; Treatment compliance; treatment related toxicity, postoperative complications and Quality of life.
To study the overall survival at 2 years. Oral cancer tissue biobanking for future translational research.
Study population Operable Oral cavity Squamous cell carcinoma with advanced nodal disease (N2-N3) Study Design Open label, Multi centric, randomized controlled trial with allocation ratio of 1:1
Sample Size The primary end point is disease-free survival. In order to have 80% power to detect a hazard ratio of 0.67, using a two-sided significance level, a total of 184 events are needed. Assuming an accrual rate of 15 patients a month, 300 patients need to be recruited. The analysis of DFS will take place 32 months after the start of the trial. The follow-up of patients will continue for 5 years. The analysis of OS will be conducted when 184 deaths are observed. taking 10% of withdrawal of consent, a total of 346 patients need to be included.
Inclusion Criteria Biopsy proven, operable oral Squamous cell carcinoma cT1-T4; cN2-N3, with adequate organ function, Age- 18-75 years, ECOG-PS:0-2 Treatment Arms
Standard Arm (SURG arm):
Surgery (Wide local Excision/composite resection with neck dissection) followed by adjuvant Radiotherapy ± Concurrent Chemotherapy
Experimental Arm (ICT):
2# TPF or TPX based induction chemotherapy followed by Surgery (Wide local Excision/composite resection with neck dissection) followed by adjuvant Radiotherapy ± Concurrent Chemotherapy
Study endpoints Primary- Disease free survival Secondary- Overall survival/ Quality of life/ Toxicity of treatment/ Treatment tolerance
- Conditions
- Oral Cancer, Head and Neck Neoplasms
- Being tested
- TPF or TPX Regimen (2# ICT) --> Surgery and Adjuvant Treatment, Surgery and Adjuvant Treatment
- Medical subject headings
- Mouth Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPF or TPX Regimen (2# ICT) --> Surgery and Adjuvant TreatmentCombination product
TPF:
IINJ DOCETAXEL 75mg/M2 in 500 ML NORMAL SALINE(PVC free container/glass bottle) via codon filter OVER 60 MIN (DAY 1 ONLY) INJ. CISPLATIN 75 MG/M 2 IN 500 ML NS IV OVER 1 HOUR ON DAY1 ONLY INJ. 5FU 750 MG/M2 IV THROUGH INFUSION PUMP OVER 24 HOURS D 1-4
Or
TPX Regimen INJ DOCETAXEL 75mg/M2 in 500 ML NORMAL SALINE(PVC free container/glass bottle) via codon filter OVER 60 MIN (DAY 1 ONLY) INJ. CISPLATIN 75 MG/M 2 IN 500 ML NS IV OVER 1 HOUR ON D1 ONLY TAB. CAPECITABINE 850-1000MG/M2 TWICE A DAY 30 MINUTES AFTER MEALS FOR 14 DAYS IN A THREE WEEKLY CYCLE
Surgery and Adjuvant Treatment Patients with PR/CR or SD will go for surgical resection. Patients having PD but still localized and resectable will be offered surgical resection, other would undergo radical CTRT or Palliative Treatment.
Surgery and Adjuvant TreatmentCombination product
Wide Local Excision (WLE) with Comprehensive neck dissection and Adjuvant Treatment as per current standard Guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Surg Arm | Active comparator | Wide Local Excision (WLE) with Comprehensive neck dissection Adjuvant Treatment as per current standard Guidelines Receives: Combination Product: Surgery and Adjuvant Treatment |
| ICT Arm | Experimental | 2# of Chemotherapy before the Stadrard Surery: Either TPF or TPX Wide Local Excision (WLE) with Comprehensive neck dissection Adjuvant Treatment as per current standard Guidelines Receives: Combination Product: TPF or TPX Regimen (2# ICT) --> Surgery and Adjuvant Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival
Date of randomization to the date of clinical or pathological evidence of recurrence
Measured: 2 Years
Secondary outcomes (9)
Overall Survival
Date of randomization to the date of death due to any reason.
Measured: 2 Years
Treatment Completion Rate
Number of Participants completing the treatment
Measured: 2 Years
Treatment Related Toxicity
Chemotherapy Related and Radiotherapy Related: Common Terminology Criteria for Adverse Events (CTCAE v5.0)
Measured: 2 Years
Quality of Life using PROs
FACT HN Scale
Measured: 3 Months; 6 Months; 12 Months; 18 Months; 24 Months; 36 Months; 48 Months; 60 Months
Postoperative Surgical Morbidity
Clavien Dindo Scale
Measured: 30 Days and 90 Days
Biobanking of Tumor, Non Tumor tissue and Blood
DNA Sequencing using NGS to assess the genetic alterations
Measured: 2 Years
Financial Toxicity using Questionnaire
FACT Scale
Measured: 3 Months; 6 Months; 12 Months; 18 Months; 24 Months; 36 Months; 48 Months; 60 Months
Early Radiotherapy Related Toxicity
RTOG Criteria
Measured: 30 Days
Late Radiotherapy Relate Toxicity
RTOG Criteria
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start20 Dec 2024
- Primary completionOct 2027 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 346 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Jodhpur
- Sponsor type
- Other government
- Collaborators
- All India Institute of Medical Sciences, Rishikesh, All India Institute of Medical Sciences, Bhubaneswar, All India Institute of Medical Sciences, Bathinda, King George's Medical University, Shri Mahant Indiresh Hospital, Dehradun, Geetanjali Medical College, Udaipur
- Responsible party
- Principal investigator, Dharma Ram Poonia, All India Institute of Medical Sciences, Jodhpur
- Investigators
- Dharma R Poonia, MS DNB, Principal investigator, AIIMS Jodhpur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737822
- Sponsor's protocol ID
- 2023/5784
- Acronym
- SurVIC
- Status last verified
- Mar 2025
- First submitted
- 7 Oct 2024
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Poonia DR, Sehrawat A, Vishnoi JR, Sharma N, Kumar P, Devnani B, Warriere A, Solanki A, Pareek P, Aggarwal D, Yadav T, Sharma PP, Gadwal A, Goyal A, Elhence P, Khera P, Jakhetiya A, Swaim P, Muduly D, Mahajan R, Garg P, Kumar V, Kar M, Misra S. Upfront surgery versus induction chemotherapy followed by surgery in oral cavity squamous cell cancers with advanced nodal disease (SurVIC Trial): a phase 3 multicentre randomised controlled trial. BMJ Open. 2025 Oct 6;15(10):e106644. doi: 10.1136/bmjopen-2025-106644.
PubMed 41057182
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upfront Surgery Vs Induction Chemotherapy Followed By Surgery In Oral Cavity Squamous Cell Cancers With Advanced Nodal Disease (SurVIC Trial): A Phase 3 Multicentric Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06737822
- Acronym / sponsor ID
- SurVIC / 2023/5784
- Conditions
- Oral Cancer, Head and Neck Neoplasms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 346 participants (estimated)
- Lead sponsor
- All India Institute of Medical Sciences, JodhpurOther government
- Collaborators
- All India Institute of Medical Sciences, Rishikesh, All India Institute of Medical Sciences, Bhubaneswar, All India Institute of Medical Sciences, Bathinda, King George's Medical University, Shri Mahant Indiresh Hospital, Dehradun, Geetanjali Medical College, Udaipur
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A majority of oral cancer patients in India present in the advanced stage hence tend to have poor oncological outcomes. Chemotherapy has been associated with improved oncological outcomes in various cancers but its role in oral cancer is not well defined in curative setting apart from radio sensitization. Attempted trials of neoadjuvant chemotherapy failed to show oncological advantage despite an excellent response rate, in part due to poor patient selection. Patients with a biologically aggressive disease are more likely to benefit, hence we intend to find out the oncological advantage of adding induction chemotherapy to oral squamous cell cancer with advanced nodal disease (N2-N3).
Earlier studies suffered from their heterogeneous patient population- all head and neck subsites together and included a spectrum ranging from early- stage operable cases to inoperable cancer. Due to such patient selection, the intended results were never met. The current study is intended to study the role of chemotherapy in curable patients who are most likely to benefit (biologically aggressive and advanced stage of presentation).
Objective
Primary:
To study the 2 year disease free survival by adding induction chemotherapy before surgery in patients of oral cancer with advanced nodal disease as compared to upfront surgery.
Secondary:
To assess treatment related outcomes between the treatment arms- Response rate; Treatment compliance; treatment related toxicity, postoperative complications and Quality of life.
To study the overall survival at 2 years. Oral cancer tissue biobanking for future translational research.
Study population Operable Oral cavity Squamous cell carcinoma with advanced nodal disease (N2-N3) Study Design Open label, Multi centric, randomized controlled trial with allocation ratio of 1:1
Sample Size The primary end point is disease-free survival. In order to have 80% power to detect a hazard ratio of 0.67, using a two-sided significance level, a total of 184 events are needed. Assuming an accrual rate of 15 patients a month, 300 patients need to be recruited. The analysis of DFS will take place 32 months after the start of the trial. The follow-up of patients will continue for 5 years. The analysis of OS will be conducted when 184 deaths are observed. taking 10% of withdrawal of consent, a total of 346 patients need to be included.
Inclusion Criteria Biopsy proven, operable oral Squamous cell carcinoma cT1-T4; cN2-N3, with adequate organ function, Age- 18-75 years, ECOG-PS:0-2 Treatment Arms
Standard Arm (SURG arm):
Surgery (Wide local Excision/composite resection with neck dissection) followed by adjuvant Radiotherapy ± Concurrent Chemotherapy
Experimental Arm (ICT):
2# TPF or TPX based induction chemotherapy followed by Surgery (Wide local Excision/composite resection with neck dissection) followed by adjuvant Radiotherapy ± Concurrent Chemotherapy
Study endpoints Primary- Disease free survival Secondary- Overall survival/ Quality of life/ Toxicity of treatment/ Treatment tolerance
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surg Arm | Active comparator | Combination Product: Surgery and Adjuvant TreatmentWide Local Excision (WLE) with Comprehensive neck dissection Adjuvant Treatment as per current standard Guidelines |
| ICT Arm | Experimental | Combination Product: TPF or TPX Regimen (2# ICT) --> Surgery and Adjuvant Treatment2# of Chemotherapy before the Stadrard Surery: Either TPF or TPX Wide Local Excision (WLE) with Comprehensive neck dissection Adjuvant Treatment as per current standard Guidelines |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Newly diagnosed, treatment naïve, biopsy or cytology proven OSCC
- Clinical Stage cT1-4a, cN2-N3**, M0- as per UICC 2018
- No evidence of distant metastases on chest x-ray and/or CT Thorax
- ECOG PS 0-2
- No contraindication to Cisplatin or radiotherapy***
Key exclusion criteria (5 listed)
- Pregnant
- History of moderate to severe hearing loss.
- History of previous malignancy excluding non-melanoma skin cancers or cervical carcinoma in situ.
- Documented Weight loss of more than 15% in the last 6 months.
- Patients with known HIV, hepatitis B or C infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TPF or TPX Regimen (2# ICT) --> Surgery and Adjuvant TreatmentTPF: IINJ DOCETAXEL 75mg/M2 in 500 ML NORMAL SALINE(PVC free container/glass bottle) via codon filter OVER 60 MIN (DAY 1 ONLY) INJ. CISPLATIN 75 MG/M 2 IN 500 ML NS IV OVER 1 HOUR ON DAY1 ONLY INJ. 5FU 750 MG/M2 IV THROUGH INFUSION PUMP OVER 24 HOURS D 1-4 Or TPX Regimen INJ DOCETAXEL 75mg/M2 in 500 ML NORMAL SALINE(PVC free container/glass bottle) via codon filter OVER 60 MIN (DAY 1 ONLY) INJ. CISPLATIN 75 MG/M 2 IN 500 ML NS IV OVER 1 HOUR ON D1 ONLY TAB. CAPECITABINE 850-1000MG/M2 TWICE A DAY 30 MINUTES AFTER MEALS FOR 14 DAYS IN A THREE WEEKLY CYCLE Surgery and Adjuvant Treatment Patients with PR/CR or SD will go for surgical resection. Patients having PD but still localized and resectable will be offered surgical resection, other would undergo radical CTRT or Palliative Treatment. | Combination product | ICT Arm |
| Surgery and Adjuvant TreatmentWide Local Excision (WLE) with Comprehensive neck dissection and Adjuvant Treatment as per current standard Guidelines. | Combination product | Surg Arm |
Primary outcome
Disease Free Survival
Time frame: 2 Years
Date of randomization to the date of clinical or pathological evidence of recurrence
9 secondary outcomes
Overall Survival
Time frame: 2 Years
Treatment Completion Rate
Time frame: 2 Years
Treatment Related Toxicity
Time frame: 2 Years
Quality of Life using PROs
Time frame: 3 Months; 6 Months; 12 Months; 18 Months; 24 Months; 36 Months; 48 Months; 60 Months
Postoperative Surgical Morbidity
Time frame: 30 Days and 90 Days
Biobanking of Tumor, Non Tumor tissue and Blood
Time frame: 2 Years
Financial Toxicity using Questionnaire
Time frame: 3 Months; 6 Months; 12 Months; 18 Months; 24 Months; 36 Months; 48 Months; 60 Months
Early Radiotherapy Related Toxicity
Time frame: 30 Days
Late Radiotherapy Relate Toxicity
Time frame: 2 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Derived from this study: PubMed 41057182Poonia DR, Sehrawat A, Vishnoi JR, Sharma N, Kumar P, Devnani B, Warriere A, Solanki A, Pareek P, Aggarwal D, Yadav T, Sharma PP, Gadwal A, Goyal A, Elhence P, Khera P, Jakhetiya A, Swaim P, Muduly D, Mahajan R, Garg P, Kumar V, Kar M, Misra S. Upfront surgery versus induction chemotherapy followed by surgery in oral cavity squamous cell cancers with advanced nodal disease (SurVIC Trial): a phase 3 multicentre randomised controlled trial. BMJ Open. 2025 Oct 6;15(10):e106644. doi: 10.1136/bmjopen-2025-106644.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dharma R Poonia, MS DNB principal investigator
AIIMS Jodhpur
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TPF or TPX Regimen (2# ICT) --> Surgery and Adjuvant Treatment and Surgery and Adjuvant Treatment in people with Oral Cancer and Head and Neck Neoplasms, run by All India Institute of Medical Sciences, Jodhpur at 7 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dharma R Poonia, MS DNB (9958654196, pooniadr@aiimsjodhpur.edu.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Free Survival (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06737822, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.