Oral Cancer Adjuvant Therapy (OCAT) Trial

• ClinicalTrials.gov Identifier: NCT00193843
• Recruitment Status: Unknown
• First Posted: September 19, 2005
• Last Update Posted: December 26, 2005
• Sponsor: Tata Memorial Hospital
• Information provided by: Tata Memorial Hospital

Study Description

Brief 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, resectable, squamous cell carcinoma of oral cavity.

Condition or disease	Intervention/treatment	Phase
Mouth Neoplasms	Procedure: Post-operative chemoradiotherapy / accelerated radiotherapy	Phase 3

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

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)

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 900 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: June 2005
• Study Completion Date: June 2017

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. Local-regional failure

Secondary Outcome Measures :

1. Overall survival
2. Treatment related toxicity
3. Protocol compliance
4. Overall treatment time
5. Quality of life: assessment by EORTC-QLQ-C30 and EORTC-H&N-35

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Rohini W. Hawaldar, BSc, DCM; 91-22-24177000 ext 4265; tmhcrs@vsnl.com

Contact: Kasturi R Awatagiri, B.Sc.Nursing; 91-22-24177000 ext 4254; awatagiri2002@yahoo.com

Locations

India

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

Mumbai, Maharashtra, India, 400012

Contact: Mandar S Deshpande, MS,DNB 91-22-24177000 ext 7218 mandarsd@yahoo.com

Contact: Rohini W Hawaldar, B.Sc, DCM 91-22-24177000 ext 4265 tmhcrs@vsnl.com

Sub-Investigator: Anil K D'cruz, MS,DNB

Sub-Investigator: Devendra A Chaukar, MS,DNB

Sub-Investigator: Pankaj C Chaturvedi, MS

Sub-Investigator: Prathamesh P Pai, MS, DORL

Sub-Investigator: Sarbani S Laskar, MD,DMRT

Sub-Investigator: Jai P Agarwal, MD

Sub-Investigator: Rajendra L Bhalavat, MD,DMRT

Sub-Investigator: Ketayun A Dinshaw, FRCR,DMRT

Sub-Investigator: Venkatesh R Pai, MD

Sub-Investigator: Kunnisherry M Mohandas, MD,DNB

Sub-Investigator: Shubhada V Kane, MD

Sub-Investigator: Tejpal Gupta, MD,DNB

Sub-Investigator: Aashish A Bakshi, MD,DM

Sub-Investigator: Amish D Vora, MD,DM

Sub-Investigator: Kumar Prabhash, MD,DM

Sub-Investigator: Ashwini N Budrukkar, MD,DMRT

Sub-Investigator: Kasturi R Awatagiri, B.Sc. Nsg

Sub-Investigator: Rohini W Hawaldar, B.Sc.DCM

Sponsors and Collaborators

Tata Memorial Hospital

Investigators

• Principal Investigator: Mandar S Deshpande, MBBS,MS,DNB; Tata Memorial Hospital, Parel, Mumbai 12, Maharashtra, India
• Principal Investigator: Mandar S Deshpande, MBBS,MS,DNB; Tata Memorial Hospital, Parel, Mumbai 12 .Maharshtra, India

More Information

• ClinicalTrials.gov Identifier: NCT00193843
• Other Study ID Numbers: TMH/177/2004
• First Posted: September 19, 2005
• Last Update Posted: December 26, 2005
• Last Verified: September 2005

Keywords provided by Tata Memorial Hospital:

Oral cancer; Head and neck surgery; Accelerated radiotherapy; Chemo-radiotherapy

Additional relevant MeSH terms:

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases