NCT00193843

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2005

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
11.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

December 26, 2005

Status Verified

September 1, 2005

First QC Date

September 13, 2005

Last Update Submit

December 23, 2005

Conditions

Mouth Neoplasms

Keywords

Oral cancerHead and neck surgeryAccelerated radiotherapyChemo-radiotherapy

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Post-operative chemoradiotherapy / accelerated radiotherapyPROCEDURE

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Mumbai, Maharashtra, 400012, India

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36669426DERIVED

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rohini W. Hawaldar, BSc, DCM

CONTACT

91-22-24177000tmhcrs@vsnl.com

Kasturi R Awatagiri, B.Sc.Nursing

CONTACT

91-22-24177000awatagiri2002@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

June 1, 2005

Study Completion

June 1, 2017

Last Updated

December 26, 2005

Record last verified: 2005-09

Locations

IN(1)