Mouth NeoplasmsPhase 3NCT00193843
Oral Cancer Adjuvant Therapy (OCAT) Trial
A Phase 3 study testing Post-operative chemoradiotherapy / accelerated radiotherapy in people with Mouth Neoplasms, run by Tata Memorial Hospital at 1 site in India.
Trial summary
To demonstrate whether addition of Concurrent chemotherapy to post-operative adjuvant radiotherapy OR shortening of duration of post-operative radiotherapy, by administering 6 fractions / week instead of 5 fractions / week improves local-regional control and / or overall survival in high risk, locally advanced… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mouth Neoplasms
- What is being tested?
- Post-operative chemoradiotherapy / accelerated radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 900 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2005to Jun 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previously untreated, resectable, loco-regionally advanced, stage III \& IV, biopsy-proven squamous cell carcinoma of the oral cavity. (Clinically lower stage patients will also be included if upstaged to pathological stage III or IV after Surgery)
- One or more of the following must be present:
- extracapsular nodal extension, involvement of > 2 regional lymph nodes, margin of resection with invasive cancer (on histopathology) Extensive soft tissue and / or skin infiltration requiring major reconstructive procedure.
- Peri-neural invasion with positive lymph node(s). Lymphovascular embolisation with positive lymph node(s). Age > 18. Karnofsky performance status of > 60. WBC > 3500, platelets > 100,000 Serum creatinine < 1.2 mg / m2 Signed study-specific informed consent form. Protocol treatment must begin within 8 weeks surgery.
Who cannot join
- Gross (visible or palpable) residual disease left after surgery. Prior chemotherapy or radiation therapy to the head and neck region.
- Evidence of distant metastasis. Any post-operative complication which will delay starting of adjuvant treatment for more than 8 weeks.
- Presence of synchronous or concurrent head and neck primary tumors. Prior malignancy within the previous 5 years. Patients who because of their medical status are not candidates for the proposed treatment.
- KPS < 60. Age > 65 years. Poor expected follow up.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Dr. Mandar. S. Deshpande, Tata Memorial Hospital, Parel
Mumbai, Maharashtra, 400012
Mandar S Deshpande, MS,DNB, 91-22-24177000 ext. 7218, mandarsd@yahoo.com
Rohini W Hawaldar, B.Sc, DCM, 91-22-24177000 ext. 4265, tmhcrs@vsnl.com
About this study
Official title: Phase III Trial of Surgery Followed by Conventional RT(5fr/Week)Vs.Concurrent Chemo-Radiotherapy Vs.Accelerated RT(6fr/Week)in High Risk, Loco-Regionally Advanced, Stage III&IVA, Resectable, Squamous Cell Carcinomas of Oralcavity
To demonstrate whether addition of Concurrent chemotherapy to post-operative adjuvant radiotherapy OR shortening of duration of post-operative radiotherapy, by administering 6 fractions / week instead of 5 fractions / week improves local-regional control and / or overall survival in high risk, locally advanced, resectable, squamous cell carcinoma of oral cavity.
Read the detailed description
Locally advanced, stage III and IVA, resectable, squamous cell carcinomas of oral cavity are conventionally treated with surgery, followed by post-operative radiotherapy. Local-regional recurrence remains the most frequent cause of failure of this treatment. The results of conventional therapy are dismal with five-year survival of less than 30% and 60-80% incidence of local-regional failure within 3 years. There are various known histological prognostic factors. The local-regional control and overall survival are extremely poor in high risk patients with these poor prognostic factors. In an attempt to improve the outcome of this high risk group, various alternative treatment policies such as addition of chemotherapy to radiotherapy or altered fractionation schedules have been tried. But till date, there is no alternative treatment modality with acceptable toxicity, available for these patients.
Aims Of Study: To demonstrate whether addition of Concurrent chemotherapy to post-operative adjuvant radiotherapy OR shortening of duration of post-operative radiotherapy, by administering 6 fractions / week instead of 5 fractions / week improves local-regional control and / or overall survival in high risk, locally advanced, resectable, squamous cell carcinoma of oral cavity.
Eligibility criteria: Locally advanced, stage III and IVA, resectable, squamous cell carcinomas of oral cavity with one of the following poor prognostic factors extracapsular nodal extension, involvement of > 2 regional lymph nodes, margin of resection with invasive cancer Extensive soft tissue and / or skin infiltration requiring major reconstructive procedure.
Peri-neural invasion with positive lymph node. Lympho-vascular embolisation with positive lymph node.
Trial Design The eligible patients will be randomly allocated to one of the three arms
- Arm 1 (Control arm): Surgery followed by conventional radiotherapy
- Arm 2: Surgery followed by Concurrent chemo-radiotherapy
- Arm 3: Surgery followed by Accelerated radiotherapy
Surgery: Surgery will be same in all three arms. Wide excision tumour with appropriate nodal dissection and reconstruction utilizing accepted criteria for the region involved will be done.
Radiotherapy: Total dose of radiotherapy will be 56 - 60 Gy. Patients in Arms 1 and 2, five fractions per week for six weeks. Patients in Arm 3, six fractions a week for five weeks.
Chemotherapy: Patients in Arm 2 will get weekly chemotherapy (Inj Cisplatin 30 mg / m2)
Stratification: Patients will be stratified according to following factors Site: Gingivo-buccal complex cancers Vs Tongue and Floor of mouth cancers. T stage. N stage. Extra-capsular spread (Peri-nodal extension) Surgical margin Extensive soft tissue infiltration
End points Primary end point: Local-regional failure. Secondary end point: Overall survival. Other parameters to be assessed are Treatment related toxicity Protocol compliance Overall treatment time Quality of life: assessment by EORTC-QLQ-C30 and EORTC-H\&N-35 Sample size: 900 pts (300 pts in each arm). Duration of accrual: 7 years. Duration of follow up: 5 years. With minimum follow up of 2 years. Analysis: Intent to treat analysis will be done. Interim analysis will be done after 450 patients (150 pts in each arm)
- Conditions
- Mouth Neoplasms
- Being tested
- Post-operative chemoradiotherapy / accelerated radiotherapy
- Keywords
- Oral cancer, Head and neck surgery, Accelerated radiotherapy, Chemo-radiotherapy
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-operative chemoradiotherapy / accelerated radiotherapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Local-regional failure
Secondary outcomes (5)
Overall survival
Treatment related toxicity
Protocol compliance
Overall treatment time
Quality of life: assessment by EORTC-QLQ-C30 and EORTC-H&N-35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJun 2005
- Study completionJun 2017
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 Mouth NeoplasmsStudies 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
- 900 participants
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Investigators
- Mandar S Deshpande, MBBS,MS,DNB, Principal investigator, Tata Memorial Hospital, Parel, Mumbai 12, Maharashtra, IndiaMandar S Deshpande, MBBS,MS,DNB, Principal investigator, Tata Memorial Hospital, Parel, Mumbai 12 .Maharshtra, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00193843
- Sponsor's protocol ID
- TMH/177/2004
- Status last verified
- Sep 2005
- First submitted
- 13 Sep 2005
- Last updated
- 26 Dec 2005
- Results posted
- No
Publications
Laskar SG, Chaukar D, Deshpande M, Chatterjee A, Sinha S, Chakraborty S, Agarwal JP, Gupta T, Budrukkar A, Murthy V, Pai P, Chaturvedi P, Pantvaidya G, Deshmukh A, Nair D, Nair S, Prabhash K, Swain M, Kumar A, Noronha V, Patil V, Joshi A, DCruz A. Oral cavity adjuvant therapy (OCAT) -a phase III, randomized controlled trial of surgery followed by conventional RT (5 fr/wk) versus concurrent CT-RT versus accelerated RT (6fr/wk) in locally advanced, resectable, squamous cell carcinoma of oral cavity. Eur J Cancer. 2023 Mar;181:179-187. doi: 10.1016/j.ejca.2022.12.016. Epub 2022 Dec 26.
PubMed 36669426
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Trial of Surgery Followed by Conventional RT(5fr/Week)Vs.Concurrent Chemo-Radiotherapy Vs.Accelerated RT(6fr/Week)in High Risk, Loco-Regionally Advanced, Stage III&IVA, Resectable, Squamous Cell Carcinomas of Oralcavity
- ClinicalTrials.gov ID
- NCT00193843
- Acronym / sponsor ID
- TMH/177/2004
- Conditions
- Mouth Neoplasms
- Keywords
- Oral cancer, Head and neck surgery, Accelerated radiotherapy, Chemo-radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- Jun 2005
- Study completion
- Jun 2017
- First posted
- 19 Sep 2005 (estimated)
- 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.
To demonstrate whether addition of Concurrent chemotherapy to post-operative adjuvant radiotherapy OR shortening of duration of post-operative radiotherapy, by administering 6 fractions / week instead of 5 fractions / week improves local-regional control and / or overall survival in high risk, locally advanced, resectable, squamous cell carcinoma of oral cavity.
Detailed description
Locally advanced, stage III and IVA, resectable, squamous cell carcinomas of oral cavity are conventionally treated with surgery, followed by post-operative radiotherapy. Local-regional recurrence remains the most frequent cause of failure of this treatment. The results of conventional therapy are dismal with five-year survival of less than 30% and 60-80% incidence of local-regional failure within 3 years. There are various known histological prognostic factors. The local-regional control and overall survival are extremely poor in high risk patients with these poor prognostic factors. In an attempt to improve the outcome of this high risk group, various alternative treatment policies such as addition of chemotherapy to radiotherapy or altered fractionation schedules have been tried. But till date, there is no alternative treatment modality with acceptable toxicity, available for these patients.
Aims Of Study: To demonstrate whether addition of Concurrent chemotherapy to post-operative adjuvant radiotherapy OR shortening of duration of post-operative radiotherapy, by administering 6 fractions / week instead of 5 fractions / week improves local-regional control and / or overall survival in high risk, locally advanced, resectable, squamous cell carcinoma of oral cavity.
Eligibility criteria: Locally advanced, stage III and IVA, resectable, squamous cell carcinomas of oral cavity with one of the following poor prognostic factors extracapsular nodal extension, involvement of > 2 regional lymph nodes, margin of resection with invasive cancer Extensive soft tissue and / or skin infiltration requiring major reconstructive procedure.
Peri-neural invasion with positive lymph node. Lympho-vascular embolisation with positive lymph node.
Trial Design The eligible patients will be randomly allocated to one of the three arms
- Arm 1 (Control arm): Surgery followed by conventional radiotherapy
- Arm 2: Surgery followed by Concurrent chemo-radiotherapy
- Arm 3: Surgery followed by Accelerated radiotherapy
Surgery: Surgery will be same in all three arms. Wide excision tumour with appropriate nodal dissection and reconstruction utilizing accepted criteria for the region involved will be done.
Radiotherapy: Total dose of radiotherapy will be 56 - 60 Gy. Patients in Arms 1 and 2, five fractions per week for six weeks. Patients in Arm 3, six fractions a week for five weeks.
Chemotherapy: Patients in Arm 2 will get weekly chemotherapy (Inj Cisplatin 30 mg / m2)
Stratification: Patients will be stratified according to following factors Site: Gingivo-buccal complex cancers Vs Tongue and Floor of mouth cancers. T stage. N stage. Extra-capsular spread (Peri-nodal extension) Surgical margin Extensive soft tissue infiltration
End points Primary end point: Local-regional failure. Secondary end point: Overall survival. Other parameters to be assessed are Treatment related toxicity Protocol compliance Overall treatment time Quality of life: assessment by EORTC-QLQ-C30 and EORTC-H\&N-35 Sample size: 900 pts (300 pts in each arm). Duration of accrual: 7 years. Duration of follow up: 5 years. With minimum follow up of 2 years. Analysis: Intent to treat analysis will be done. Interim analysis will be done after 450 patients (150 pts in each arm)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Previously untreated, resectable, loco-regionally advanced, stage III \& IV, biopsy-proven squamous cell carcinoma of the oral cavity. (Clinically lower stage patients will also be included if upstaged to pathological stage III or IV after Surgery)
- extracapsular nodal extension, involvement of > 2 regional lymph nodes, margin of resection with invasive cancer (on histopathology) Extensive soft tissue and / or skin infiltration requiring major reconstructive procedure.
- Peri-neural invasion with positive lymph node(s). Lymphovascular embolisation with positive lymph node(s). Age > 18. Karnofsky performance status of > 60. WBC > 3500, platelets > 100,000 Serum creatinine < 1.2 mg / m2 Signed study-specific informed consent form. Protocol treatment must begin within 8 weeks surgery.
Key exclusion criteria (4 listed)
- Gross (visible or palpable) residual disease left after surgery. Prior chemotherapy or radiation therapy to the head and neck region.
- Evidence of distant metastasis. Any post-operative complication which will delay starting of adjuvant treatment for more than 8 weeks.
- Presence of synchronous or concurrent head and neck primary tumors. Prior malignancy within the previous 5 years. Patients who because of their medical status are not candidates for the proposed treatment.
- KPS < 60. Age > 65 years. Poor expected follow up.
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 |
|---|---|---|
| Post-operative chemoradiotherapy / accelerated radiotherapy | Procedure or surgery | – |
Primary outcome
Local-regional failure
5 secondary outcomes
Overall survival
Treatment related toxicity
Protocol compliance
Overall treatment time
Quality of life: assessment by EORTC-QLQ-C30 and EORTC-H&N-35
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2005.
- Derived from this study: PubMed 36669426Laskar SG, Chaukar D, Deshpande M, Chatterjee A, Sinha S, Chakraborty S, Agarwal JP, Gupta T, Budrukkar A, Murthy V, Pai P, Chaturvedi P, Pantvaidya G, Deshmukh A, Nair D, Nair S, Prabhash K, Swain M, Kumar A, Noronha V, Patil V, Joshi A, DCruz A. Oral cavity adjuvant therapy (OCAT) -a phase III, randomized controlled trial of surgery followed by conventional RT (5 fr/wk) versus concurrent CT-RT versus accelerated RT (6fr/wk) in locally advanced, resectable, squamous cell carcinoma of oral cavity. Eur J Cancer. 2023 Mar;181:179-187. doi: 10.1016/j.ejca.2022.12.016. Epub 2022 Dec 26.
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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. This study is not recruiting at the moment.
Mandar S Deshpande, MBBS,MS,DNB principal investigator
Tata Memorial Hospital, Parel, Mumbai 12, Maharashtra, India
Mandar S Deshpande, MBBS,MS,DNB principal investigator
Tata Memorial Hospital, Parel, Mumbai 12 .Maharshtra, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Post-operative chemoradiotherapy / accelerated radiotherapy in people with Mouth Neoplasms, run by Tata Memorial Hospital at 1 site 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rohini W. Hawaldar, BSc, DCM (91-22-24177000 ext. 4265, tmhcrs@vsnl.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local-regional failure. 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 NCT00193843, 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 26 Dec 2005.