MedDataX Logo

Oral Cancer Adjuvant Therapy (OCAT) Trial

NCT ID: NCT00193843

Last Updated: 2005-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

1. Arm 1 (Control arm): Surgery followed by conventional radiotherapy
2. Arm 2: Surgery followed by Concurrent chemo-radiotherapy
3. 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

See the medical conditions and disease areas that this research is targeting or investigating.

Mouth Neoplasms

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Oral cancer Head and neck surgery Accelerated radiotherapy Chemo-radiotherapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Post-operative chemoradiotherapy / accelerated radiotherapy

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.

Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tata Memorial Hospital

OTHER_GOV

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mandar S Deshpande, MBBS,MS,DNB

Role: PRINCIPAL_INVESTIGATOR

Tata Memorial Hospital, Parel, Mumbai 12, Maharashtra, India

Mandar S Deshpande, MBBS,MS,DNB

Role: PRINCIPAL_INVESTIGATOR

Tata Memorial Hospital, Parel, Mumbai 12 .Maharshtra, India

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dr. Mandar. S. Deshpande, Tata Memorial Hospital, Parel

Mumbai, Maharashtra, India

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

India

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Rohini W. Hawaldar, BSc, DCM

Role: CONTACT

Phone: 91-22-24177000

Email: [email protected]

Kasturi R Awatagiri, B.Sc.Nursing

Role: CONTACT

Phone: 91-22-24177000

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mandar S Deshpande, MS,DNB

Role: primary

Rohini W Hawaldar, B.Sc, DCM

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 36669426 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TMH/177/2004

Identifier Type: -

Identifier Source: org_study_id