Phase III randomized trial of preoperative concurrent chemoradiotherapy versus preoperative radiotherapy in the treatment of locally advanced head and neck squamous cell carcinoma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-14004322

Enrollment

Unknown

Registered

2014-03-03

Start date

2002-09-02

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Locally advanced head and neck Squamous cell carcinoma

Interventions

Preoperative concurrent chemoradiotherapy group:concurrent chemotherapy

preoperative radiohterapy group:preoperative radiohterapy

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Pathological proved clinical stage III/IV M0 squamous cell carcinoma oringinated from oral cavity, oropharynx, hypopharynx and larynx; 2. Karnovsky performence >70; 3. aged 18 to 70, with expectancy life time > 6month; 4. patients with normal blood routine test; 5. patients with normal liver and renal function; 6. without heart infraction history within past 6 month; 7. with no irradiation to the head and neck region and no chemotherapy for head and neck cancer; 8. no non-melanoma skin cancer histoy or other malignant tumor in head and neck; 9. patients have signed the inform consent; 10. without psychopathy.

Exclusion criteria

Exclusion criteria: 1. pathological proved non-squamous cell carcinoma; 2. with distant metastasis evidence before and during treatment; 3. Previously receivedchemotherapy for any reason and/or received radiotherapy in head and neck region; 4. patients received surgery as first treatment choice, except biopsy for primary site and lymph node; 5. with synchronization tumor at other site; 6. with pregnancy; 7. with serious diabetes and other circumstances of contraindication for using steroids.

Design outcomes

Primary

Measure	Time frame
Overall survival;	—

Secondary

Measure	Time frame
progression-free survival;local control rate;Distant metastasis-free survival;	—

Countries

China

Contacts

Public ContactGao Li

Cancer Hospital, Chinese Academy of Medical Sciences

li_gao2008@outlook.com+86 13801371743

Outcome results

None listed

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