Randomised trial comparing Upfront surgery versus chemoradiotherapy (CCRT) in Head and Neck squamous cell carcinoma of unknown primary with neck node metastasis:

Upfront surgery followed by adjuvant treatment versus chemoradiotherapy (CCRT) in Head and Neck squamous cell carcinoma of unknown primary with neck node metastasis:A phase III randomized controlled trial. - SCCoUP Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/01/030749

Enrollment

364

Registered

2021-01-25

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C801- Malignant (primary) neoplasm, unspecified Health Condition 2: C760- Malignant neoplasm of head, face and neck

Interventions

Intervention1: Upfront Surgery Followed by adjuvant treatment: Neck dissection followed by adjuvant therapy as indicated. Surgery will be performed upfront, it had to be performed within 4 weeks of ra

Eligibility

Inclusion criteria

Inclusion criteria: 1. Head Neck Cancer of Unknown Primary (HNCUP), as defined by AJCC 8th edition. 2. Squamous cell carcinoma only. 3. Karnofsky performance status >=70 and adequate hematologic, renal, and hepatic function. 4. Patients consenting to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Lymph node (core) biopsy positive patients for HPV (p16-IHC) and EBV (EBV-ISH) and 2. Isolated Level IV metastasis in a case of HNCUP 3. Prior chemotherapy or radiation therapy to the head and neck region. 4. Evidence of distant metastasis. 5. Prior malignancy within the previous 5 years, other than curatively treated skin cancer or cervical intraepithelial neoplasia. 5. Pregnant and lactating women. 6. Unresectable nodal disease 7. Exclusion criteria for cisplatin, i.e. â?? The presence of moderate to severe sensorineural hearing loss. â?? The presence of renal dysfunction, i.e. creatinine clearance â?? The presence of inadequate bone marrow reserve, as defined as Hb â?? The presence of hepatic dysfunction, i.e. bilirubin >= 2 x upper limit normal (ULN), AST/ALT/ALP >= 2.5 xULN, S. albumin 8. Serious co-morbidities such as severe cardiac failure or severe pulmonary compromise or severe and active infections.

Design outcomes

Primary

Measure	Time frame
To test whether upfront surgery followed by adjuvant treatment offers better overall survival in comparison to chemoradiotherapy followed by salvage neck dissection for residual disease. Timepoint: at 3-6 months	—

Secondary

Measure	Time frame
1. Disease-free survival (DFS) 2. Loco-regional control (disease progression/recurrent or new disease /death due to any cause) 3. Treatment-related toxicity (CTCAE/Clavin-Dindo Classification) 4. QoL (EORTC-QLQ-30, HN-35) Timepoint: 1. Patient will be assessed during routine treatment. 2. After treatment completion patient will be clinically evaluated after 6 weeks & will undergo response assesment scan (PET-CT/CECT scan) at 10-12 weeks. 3.Further evaluation will be based on any clinical or radiological suspicion. 4.All enrolled patients will be followed up for at least 3 years.	—

Measure

Time frame

1. Disease-free survival (DFS) 2. Loco-regional control (disease progression/recurrent or new disease /death due to any cause) 3. Treatment-related toxicity (CTCAE/Clavin-Dindo Classification) 4. QoL (EORTC-QLQ-30, HN-35) Timepoint: 1. Patient will be assessed during routine treatment. 2. After treatment completion patient will be clinically evaluated after 6 weeks & will undergo response assesment scan (PET-CT/CECT scan) at 10-12 weeks. 3.Further evaluation will be based on any clinical or radiological suspicion. 4.All enrolled patients will be followed up for at least 3 years.

—

Countries

India

Contacts

Public ContactDr SHIVAKUMAR THIAGARAJAN

Tata Memorial Centre

drshiva78in@gmail.com9846572399

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026