NCT07528495 A Trial Evaluating Omission of Radiotherapy to Regional Lymphatic's
| NCT ID | NCT07528495 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | All India Institute of Medical Sciences |
| Condition | Head and Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 396 participants |
| Start Date | 2024-04-03 |
| Primary Completion | 2027-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 396 participants in total. It began in 2024-04-03 with a primary completion date of 2027-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The present study is a phase II/III prospective randomized trial designed to determine whether eliminating of post operative radiotherapy to regional lymphatics in pN0-N1oral cavity is associated with similar treatment outcomes.
Eligibility Criteria
Inclusion Criteria: 1. Aged 18 or above and less than 70 years 2. Stage pT1-4histological confirmed squamous cell carcinoma of oral cavity undergoing radical excision and ipsilateral/bilateral neck dissection. 3. Patient with high risk features: positive or close (≤ 5mm) margin, presence of LVI or PNI, pT3-4 4. At least one dissected hemi-neck (at least 12 nodes recovered in one dissected hemi-neck) 5. Pathological N0/ N1 neck and high risk features undergoing radiotherapy for HNSCC of the oral cavity 6. Brandwein-Gensler (BG) histological risk assessment in all patients 7. Karnofsky performance score greater or equal 70 8. Ability to complete the MD Anderson Dysphagia Inventory (MDADI) and EORTC quality of life questionnaires English or Hindi Version. 9. Timely delivery of PORT preferable within 6weeks of surgery (upto 1-2 weeks of delay beyond 6 weeks is permissible to accommodate for delayed wound healing or other logistics) 10. Written informed consent for treatment. 11. Available to attend long term follow- up Exclusion Criteria: 1. Non squamous histology 2. Presences of distant metastases 3. pT1-2 disease and no high risk features 4. Pathologically N2/N3 disease. 5. Patients that require re-irradiation for recurrent disease 6. Inadequate neck dissection (less than 12 nodes examined) 7. Primary tumor reaching midline (within 1 cm from midline) and only ipsilateral neck dissection done 8. Initiation of PORT after 8 weeks of radical surgery. 9. Previous radiotherapy to the head and neck region 10. Any invasive malignancy within previous 2 years (other than non melanomatous skin carcinoma or cervical carcinoma in situ). 11. Age \< 18 years or \> 70 years 12. Brandwein-Gensler (BG) histological risk not done
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07528495 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07528495 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07528495 currently recruiting?
Yes, NCT07528495 is actively recruiting participants. Contact the research team at amans757@gmail.com for enrollment information.
Where is the NCT07528495 trial being conducted?
This trial is being conducted at Jhajjar, India.
Who is sponsoring the NCT07528495 clinical trial?
NCT07528495 is sponsored by All India Institute of Medical Sciences. The trial plans to enroll 396 participants.
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