NCT07528495

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
396

participants targeted

Target at P75+ for phase_2 head-and-neck-cancer

Timeline
24mo left

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress52%
Apr 2024Apr 2028

First Submitted

Initial submission to the registry

December 6, 2022

Completed
1.3 years until next milestone

Study Start

First participant enrolled

April 3, 2024

Completed
2 years until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2028

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

3.7 years

First QC Date

December 6, 2022

Last Update Submit

April 30, 2026

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • Regional control

    Regional control will be assessed as occurrence of any new lesion in the regional /nearby area over time with the help of radiological imaging (CT/MRI/PET-CT) and clinical examination. will be assessed at 3 months, 6 months, 12 months, 18 months, 24 months

    2 years

Secondary Outcomes (8)

  • Local control

    2 years

  • Disease free survival

    2 years

  • Overall survival

    2 years

  • Acute toxicity

    2 years

  • late toxicity

    2 years

  • +3 more secondary outcomes

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Post operative radiotherapy to primary tumor bed and regional lymphatics

Radiation: IMRT - adjuvant concurrent CRT/ RTDrug: Cisplatin

Arm B

EXPERIMENTAL

Post operative radiotherapy to primary tumor bed but omission of PORT to regional lymphatics

Radiation: ommission of IMRT - adjuvant concurrent CRT/ RT for regional lymphaticsDrug: Cisplatin

Interventions

CisplatinDRUG

Cisplatin is a antineoplastic drug, will be given during the radiation at a dose of 40 mg/m2 weekly to a cumulative dose of at least 200 mg/m2 in case of margin positive disease.

Arm AArm B
IMRT - adjuvant concurrent CRT/ RTRADIATION

IMRT - adjuvant concurrent CRT/ RT as 66Gy/33fr or 60Gy/30fr or 50Gy/20fr to primary and regional lymphatics

Arm A
ommission of IMRT - adjuvant concurrent CRT/ RT for regional lymphaticsRADIATION

IMRT- adjuvant concurrent CRT/ RT as 66Gy/33fr or 60Gy/30fr or 50Gy/20fr / Brachytherapy 40-48 Gy in10-12 fractions twice daily at least 6 hours apart, to primary tumor bed only \- elimination of regional lymphatics

Arm B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 or above and less than 70 years
  • Stage pT1-4histological confirmed squamous cell carcinoma of oral cavity undergoing radical excision and ipsilateral/bilateral neck dissection.
  • Patient with high risk features: positive or close (≤ 5mm) margin, presence of LVI or PNI, pT3-4
  • At least one dissected hemi-neck (at least 12 nodes recovered in one dissected hemi-neck)
  • Pathological N0/ N1 neck and high risk features undergoing radiotherapy for HNSCC of the oral cavity
  • Brandwein-Gensler (BG) histological risk assessment in all patients
  • Karnofsky performance score greater or equal 70
  • Ability to complete the MD Anderson Dysphagia Inventory (MDADI) and EORTC quality of life questionnaires English or Hindi Version.
  • 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)
  • Written informed consent for treatment.
  • Available to attend long term follow- up

You may not qualify if:

  • Non squamous histology
  • Presences of distant metastases
  • pT1-2 disease and no high risk features
  • Pathologically N2/N3 disease.
  • Patients that require re-irradiation for recurrent disease
  • Inadequate neck dissection (less than 12 nodes examined)
  • Primary tumor reaching midline (within 1 cm from midline) and only ipsilateral neck dissection done
  • Initiation of PORT after 8 weeks of radical surgery.
  • Previous radiotherapy to the head and neck region
  • Any invasive malignancy within previous 2 years (other than non melanomatous skin carcinoma or cervical carcinoma in situ).
  • Age \< 18 years or \> 70 years
  • Brandwein-Gensler (BG) histological risk not done

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nci, Aiims

Jhajjar, Haryana, 124105, India

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Central Study Contacts

Aman Sharma, MD

CONTACT

+91117018529339amans757@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Principal Investigator, Radiation Oncology

Study Record Dates

First Submitted

December 6, 2022

First Posted

April 14, 2026

Study Start

April 3, 2024

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

April 3, 2028

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)