Clinical trial · Interventional
Oral Cancer Adjuvant Therapy (OCAT) Trial
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mouth Neoplasms | Oral Cavity Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Post-operative chemoradiotherapy / accelerated radiotherapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Local-regional failure
Secondary outcomes (5)
- measure
- Overall survival
- measure
- Treatment related toxicity
- measure
- Protocol compliance
- measure
- Overall treatment time
- measure
- Quality of life: assessment by EORTC-QLQ-C30 and EORTC-H&N-35
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDLaskar 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 36669426